PsychosisNCT02946255
Testing the Effectiveness of The Welcome Basket Intervention
A study testing Welcome Basket (WB), Welcome Basket Brief (WBbr) and Treatment As Usual in people with Psychosis, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The investigators propose to examine the effectiveness of a brief intervention that might better facilitate the transition into the community for people with schizophrenia or bipolar disorder with psychotic features. The intervention is called the Welcome Basket. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosis
- What is being tested?
- Welcome Basket (WB), Welcome Basket Brief (WBbr) and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- 16 May 2017to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be adults, 18 years of age or older, with a chart diagnosis of a schizophrenia spectrum mental illness or bipolar disorder with psychotic features confirmed by Module B (psychotic symptoms) of the Structured Clinical Interview for DSM-5 (SCID-5) (First, William, Karg, \& Spitzer, 2015). All participants will be on CAMH inpatient units at the time of recruitment and will have been in continuous inpatient care for close to or more than 2 weeks. This timeframe is guided by the rationale and experience indicating that an overly brief period of hospitalization circumscribes the relevance of the intervention.
- Participants will be returning to places of residence in the Greater Toronto Area (catchment of CAMH) or can travel to the GTA if they will reside outside the catchment area.
- Participants must have been referred to outpatient case management.
- Proposed housing arrangements must be stable and conducive to the intervention. If homelessness or emergency shelter residence appears likely, or boarding home policy precludes any external staff from entering the premises, such individuals will be excluded.
- Proficiency in English.
Who cannot join
- 1. Do not meet the above criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Effectiveness of a Brief, Peer Support Intervention to Facilitate Transition Form Psychiatric Hospitalization
The investigators propose to examine the effectiveness of a brief intervention that might better facilitate the transition into the community for people with schizophrenia or bipolar disorder with psychotic features. The intervention is called the Welcome Basket. It involves Peer Support Workers connecting with and supporting hospitalized individuals in the days before discharge and again in the community in the first month immediately following discharge. The investigators will compare the outcomes of discharge from hospital as usual with the full version of the welcome basket and a preliminary test of an abbreviated 2 visit version of the intervention.
Read the detailed description
Discharge from hospital has been highlighted as a critical time in the care of individuals with mental illness. The peak period of risk for readmission for individuals with severe mental illness is in the first month and the highest risk for post-discharge suicide is within the first 2 weeks with discontinuity of contact with providers highlighted as a key risk factor. One half of individuals with schizophrenia miss their first-scheduled outpatient appointment following discharge and this time is a key period of risk for medication non-compliance. Common problems that occur at the time of discharge from psychiatric care settings include poor communication between inpatient and outpatient providers and inadequate involvement and support of families. The research literature on effective practices linked with discharge is strikingly sparse given the evidence that this is a period of heightened risk.
The investigators hypothesize that the Welcome Basket intervention will improve the discharge-related outcomes of individuals with schizophrenia or bipolar disorder with psychotic features compared to treatment as usual. Investigators will also explore the outcomes of an abbreviated, 2-visit version of the intervention. This study will employ a randomized, controlled trial design. Inpatient clients with a diagnosis of schizophrenia spectrum mental illness or bipolar disorder with psychotic features will be randomized with a 2:2:1 ratio to: treatment as usual, the full welcome basket intervention, and the abbreviated intervention. Measures will include re-hospitalization, symptomatology, quality of life, and community functioning. Assessments at baseline, 4 weeks post-discharge, and 6 months post-discharge will facilitate studies of relative effectiveness and sustainment of gains. This design will facilitate an examination of both overall outcomes as well as some preliminary dismantling of mechanisms of action.
- Conditions
- Psychosis
- Being tested
- Welcome Basket (WB), Welcome Basket Brief (WBbr), Treatment As Usual
- Keywords
- Psychosis, Psychosis NOS, Schizophrenia, Hospital discharge, Inpatient psychiatry
- Medical subject headings
- Psychotic Disorders, Mental Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Welcome Basket (WB)Behavioural
Peer Support Workers (PSWs) hold 1-2 meetings with clients (30-60 minutes) in the 2-week period before they are discharged from hospital. They describe the program and undertake an assessment. From this assessment the two core components of the intervention are initiated. First, a "welcome basket" is created for the client. The PSW also forms a plan with the client about tours of their neighbourhood to familiarize them with the local resources and support them in building confidence in accessing their local communities. These activities will take place through weekly visits (2 hours/visit) in the 4 weeks immediately following discharge. WB will be provided in combination with core Cognitive Adaptation Training (CAT) compensatory interventions.
Welcome Basket Brief (WBbr)Behavioural
The brief version of the Welcome Basket (WBbr) was developed based upon the observation in feasibility testing that for some participants much of the benefit of this approach appeared to be centred upon the visits immediately prior and subsequent to discharge. In the WBbr the same core components will be present, albeit in an abbreviated form with one 30-60 minute visit in the week prior to discharge and a single, 3-hour visit in the week subsequent to discharge in which the welcome basket would be delivered, core CAT strategies discussed and implemented, and some basic orientation to community resources undertaken. This brief version of the intervention has not to date been studied.
Treatment As UsualBehavioural
Treatment as usual (TAU) involves the typical discharge procedures for clients from Unit 2, Forensic and EPU wards at CAMH. It includes referral to outpatient psychiatric services and relevant community supports with the transition facilitated by inpatient social work staff.
| Study group | Role | What they receive |
|---|---|---|
| Welcome Basket Brief (WBbr) | Experimental | The brief version of the Welcome Basket (WBbr) was developed based upon the observation in feasibility testing that for some participants much of the benefit of this approach appeared to be centred upon the visits immediately prior and subsequent to discharge. In the WBbr the same core components will be present, albeit in an abbreviated form with one 30-60 minute visit in the week prior to discharge and a single, 3-hour visit in the week subsequent to discharge in which the welcome basket would be delivered, core CAT strategies discussed and implemented, and some basic orientation to community resources undertaken. This brief version of the intervention has not to date been studied. Receives: Behavioral: Welcome Basket Brief (WBbr) |
| Welcome Basket (WB) | Experimental | Peer Support Workers (PSWs) hold 1-2 meetings with clients (30-60 minutes) in the 2-week period before they are discharged from hospital. They describe the program and undertake an assessment. From this assessment the two core components of the intervention are initiated. First, a "welcome basket" is created for the client. The PSW also forms a plan with the client about tours of their neighbourhood to familiarize them with the local resources and support them in building confidence in accessing their local communities. These activities will take place through weekly visits (2 hours/visit) in the 4 weeks immediately following discharge. WB will be provided in combination with core Cognitive Adaptation Training (CAT) compensatory interventions. Receives: Behavioral: Welcome Basket (WB) |
| Treatment As Usual | Active comparator | Treatment as usual (TAU) involves the typical discharge procedures for clients from Unit 2, Forensic and EPU wards at CAMH. It includes referral to outpatient psychiatric services and relevant community supports with the transition facilitated by inpatient social work staff. Receives: Behavioral: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multnomah Community Ability Scale - Participant Interview Based
Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.
Measured: Baseline
Multnomah Community Ability Scale - Participant Interview Based
Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.
Measured: 4 Week Follow-Up
Multnomah Community Ability Scale - Participant Interview Based
Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.
Measured: 6 Month Follow-Up
Multnomah Community Ability Scale - Clinician Based
Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.
Measured: Baseline
Multnomah Community Ability Scale - Clinician Based
Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.
Measured: 4 Week Follow-Up
Multnomah Community Ability Scale - Clinician Based
Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.
Measured: 6 Month Follow-Up
Secondary outcomes (17)
Hospitalizations and Emergency Room Visits
The percentage of participants that were re-hospitalized or visited the emergency room during the study were captured through case manager report and verified through hospital electronic database if a CAMH hospitalization.
Measured: Baseline to 6 Month Follow-Up
The Satisfaction With Life Scale
Quality of Life will be assessed with the Satisfaction With Life scale, an 18-item scale comprised of 4 subscales assessing living situation (4 items), social relationships (6 items), work (2 items), self and present life (6 items). Items are rated from 0 (not at all) to 1 (very little) to 2 (average or OK) to 3 (a lot) to 4 (a great deal). Subscale scores are reported here. The min value for all subscales is 0. The max value for the Living Situation subscale is 16. The max value for both the Social Relationships subscale and the Self and Present Life subscale is 24. The max value for the Work subscale is 8. Higher subscale scores indicate better outcomes (i.e., greater satisfaction with that area of life).
Measured: 4 Week Follow-Up
The Satisfaction With Life Scale
Quality of Life will be assessed with the Satisfaction With Life scale, an 18-item scale comprised of 4 subscales assessing living situation (4 items), social relationships (6 items), work (2 items), self and present life (6 items). Items are rated from 0 (not at all) to 1 (very little) to 2 (average or OK) to 3 (a lot) to 4 (a great deal). Subscale scores are reported here. The min value for all subscales is 0. The max value for the Living Situation subscale is 16. The max value for both the Social Relationships subscale and the Self and Present Life subscale is 24. The max value for the Work subscale is 8. Higher subscale scores indicate better outcomes (i.e., greater satisfaction with that area of life).
Measured: 6 Month Follow-Up
Social Support Survey
Quality of Life will also be assessed using the Social Support Survey, a 19 item scale that measures emotional/information support, tangible support, affectionate support and positive social interaction. Overall support index (i.e., Total Score) is reported here and is calculated from averaging all items and then applying a transformation [i.e., minimum possible score subtracted from observed score (first difference) and maximum possible score (second difference) and then the first difference divided by the second difference and that quotient multiplied by 100] such that the min score is 0 and the max is 100. Higher scores indicate better outcomes (i.e., more frequent availability of different types of support).
Measured: Baseline
Social Support Survey
Quality of Life will also be assessed using the Social Support Survey, a 19 item scale that measures emotional/information support, tangible support, affectionate support and positive social interaction. Overall support index (i.e., Total Score) is reported here and is calculated from averaging all items and then applying a transformation [i.e., minimum possible score subtracted from observed score (first difference) and maximum possible score (second difference) and then the first difference divided by the second difference and that quotient multiplied by 100] such that the min score is 0 and the max is 100. Higher scores indicate better outcomes (i.e., more frequent availability of different types of support).
Measured: 4 Week Follow-Up
Social Support Survey
Quality of Life will also be assessed using the Social Support Survey, a 19 item scale that measures emotional/information support, tangible support, affectionate support and positive social interaction. Overall support index (i.e., Total Score) is reported here and is calculated from averaging all items and then applying a transformation [i.e., minimum possible score subtracted from observed score (first difference) and maximum possible score (second difference) and then the first difference divided by the second difference and that quotient multiplied by 100] such that the min score is 0 and the max is 100. Higher scores indicate better outcomes (i.e., more frequent availability of different types of support).
Measured: 6 Month Follow-Up
Brief Symptom Inventory
Changes in symptomatology will be assessed with the 53 item Brief Symptom Inventory (BSI); this widely used instrument has extensively demonstrated validity and reliability properties and assesses a wide range of symptom areas. Participants rank how distressing symptoms are from 0 (not at all) to 4 (a great deal). The 52 items are organized into 9 symptom dimensions: Somatization, Obsession-Compulsions, Interpersonal Sensitivity Items, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Dimension scores are calculated by summing the values for the items included in that dimension and dividing by the number of items endorsed in that dimension. The Global Severity Index (GSI) is reported here. The GSI is calculated by summing all the dimensions plus four additional items and dividing by the total number of items responded to. The min value is 0 and the max value is 72. Higher scores indicate worse outcomes (i.e., more distressing symptoms).
Measured: Baseline
Brief Symptom Inventory
Changes in symptomatology will be assessed with the 53 item Brief Symptom Inventory (BSI); this widely used instrument has extensively demonstrated validity and reliability properties and assesses a wide range of symptom areas. Participants rank how distressing symptoms are from 0 (not at all) to 4 (a great deal). The 52 items are organized into 9 symptom dimensions: Somatization, Obsession-Compulsions, Interpersonal Sensitivity Items, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Dimension scores are calculated by summing the values for the items included in that dimension and dividing by the number of items endorsed in that dimension. The Global Severity Index (GSI) is reported here. The GSI is calculated by summing all the dimensions plus four additional items and dividing by the total number of items responded to. The min value is 0 and the max value is 72. Higher scores indicate worse outcomes (i.e., more distressing symptoms).
Measured: 4 Week Follow-Up
Brief Symptom Inventory
Changes in symptomatology will be assessed with the 53 item Brief Symptom Inventory (BSI); this widely used instrument has extensively demonstrated validity and reliability properties and assesses a wide range of symptom areas. Participants rank how distressing symptoms are from 0 (not at all) to 4 (a great deal). The 52 items are organized into 9 symptom dimensions: Somatization, Obsession-Compulsions, Interpersonal Sensitivity Items, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Dimension scores are calculated by summing the values for the items included in that dimension and dividing by the number of items endorsed in that dimension. The Global Severity Index (GSI) is reported here. The GSI is calculated by summing all the dimensions plus four additional items and dividing by the total number of items responded to. The min value is 0 and the max value is 72. Higher scores indicate worse outcomes (i.e., more distressing symptoms).
Measured: 6 Month Follow-Up
Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale
The 5-item Global Appraisal of Individual Needs Short Screener (GAIN-SS) Substance Disorder Subscale (5-items) will be used to measure common psychological, behavioral, and personal problems related to alcohol and drug use. Each item is rated from 4 to 0 with 4, 3 and 2 representing use or problems in the past month, 2-3 months ago and 4-12 months ago, respectively. Items rated 1 represent problems over a year ago and items rated 0 indicate never having that problem. The subscale score is the total number of responses that indicate substance use problems within the last year. Substance Disorder Subscale scores for each arm are reported here. The min value is 0 and the max value is 5. Higher scores indicate worse outcomes (i.e., more severe problems related to substance use).
Measured: Baseline
Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale
The 5-item Global Appraisal of Individual Needs Short Screener (GAIN-SS) Substance Disorder Subscale (5-items) will be used to measure common psychological, behavioral, and personal problems related to alcohol and drug use. Each item is rated from 4 to 0 with 4, 3 and 2 representing use or problems in the past month, 2-3 months ago and 4-12 months ago, respectively. Items rated 1 represent problems over a year ago and items rated 0 indicate never having that problem. The subscale score is the total number of responses that indicate substance use problems within the last year. Substance Disorder Subscale scores for each arm are reported here. The min value is 0 and the max value is 5. Higher scores indicate worse outcomes (i.e., more severe problems related to substance use).
Measured: 4 Week Follow-Up
Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale
The 5-item Global Appraisal of Individual Needs Short Screener (GAIN-SS) Substance Disorder Subscale (5-items) will be used to measure common psychological, behavioral, and personal problems related to alcohol and drug use. Each item is rated from 4 to 0 with 4, 3 and 2 representing use or problems in the past month, 2-3 months ago and 4-12 months ago, respectively. Items rated 1 represent problems over a year ago and items rated 0 indicate never having that problem. The subscale score is the total number of responses that indicate substance use problems within the last year. Substance Disorder Subscale scores for each arm are reported here. The min value is 0 and the max value is 5. Higher scores indicate worse outcomes (i.e., more severe problems related to substance use).
Measured: 6 Month Follow-Up
Personal Recovery Outcome Measure
The brief, 10-item version of the Personal Recovery Outcome Measure was used to assess change in recovery engagement. Total score is reported here. Total score is calculated by summing all the responses. Min total score value is 0 and max total score value is 40. Higher scores indicate better outcomes (i.e., more engagement in recovery).
Measured: Baseline
Personal Recovery Outcome Measure
The brief, 10-item version of the Personal Recovery Outcome Measure was used to assess change in recovery engagement. Total score is reported here. Total score is calculated by summing all the responses. Min total score value is 0 and max total score value is 40. Higher scores indicate better outcomes (i.e., more engagement in recovery).
Measured: 4 Week Follow-Up
Personal Recovery Outcome Measure
The brief, 10-item version of the Personal Recovery Outcome Measure was used to assess change in recovery engagement. Total score is reported here. Total score is calculated by summing all the responses. Min total score value is 0 and max total score value is 40. Higher scores indicate better outcomes (i.e., more engagement in recovery).
Measured: 6 Month Follow-Up
Community Integration Scale
Community involvement will be assessed with the 11 item Community Integration Scale which was developed for the At Home study with a comparable population to assesses psychological and behavioural community engagement. The first 7 items measure physical integration (community presence) and the remaining 4 items measure psychological integration (sense of belonging). Community Involvement was assessed post intervention and at follow up and not during inpatient stay since it would not be valid due to contextual confounds with items. Total scores (i.e, the average of the responses) are reported here. The min total score value is -1 and the max is 2.5. Higher scores indicate better outcomes (i.e., greater community engagement)
Measured: 4 Week Follow-Up
Community Integration Scale
Community involvement will be assessed with the 11 item Community Integration Scale which was developed for the At Home study with a comparable population to assesses psychological and behavioural community engagement. The first 7 items measure physical integration (community presence) and the remaining 4 items measure psychological integration (sense of belonging). Community Involvement was assessed post intervention and at follow up and not during inpatient stay since it would not be valid due to contextual confounds with items. Total scores (i.e, the average of the responses) are reported here. The min total score value is -1 and the max is 2.5. Higher scores indicate better outcomes (i.e., greater community engagement)
Measured: 6 Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start16 May 2017
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Kidd, Centre for Addiction and Mental Health
- Investigators
- Sean A Kidd, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946255
- Sponsor's protocol ID
- 073/2016
- Status last verified
- Aug 2023
- First submitted
- 12 Oct 2016
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barker S, Barron N, McFarland BH, Bigelow DA. A community ability scale for chronically mentally ill consumers: Part I. Reliability and validity. Community Ment Health J. 1994 Aug;30(4):363-83. doi: 10.1007/BF02207489.
PubMed 7956112Lee, K., Brekke, J., Yamada, A., & Chou, C. (2010). Longitudinal invariance of the satisfaction with life scale for individuals with schizophrenia. Research on Social Work Practice, 20(2), 234-241.
Derogatis, L.R.(1993). BSI Brief Symptom Inventory: Administration, Scoring, and Procedure Manual (4th Ed.). Minneapolis, MN: National Computer Systems.
Barbic, S., Kidd, SA, Backman, C., MacEwan, W.. Honer, W., & McKenzie, K. (2016). The development and testing of the Personal Recovery Outcome Measure (PROM) [in preparation].
Stergiopoulos V, Gozdzik A, Misir V, Skosireva A, Connelly J, Sarang A, Whisler A, Hwang SW, O'Campo P, McKenzie K. Effectiveness of Housing First with Intensive Case Management in an Ethnically Diverse Sample of Homeless Adults with Mental Illness: A Randomized Controlled Trial. PLoS One. 2015 Jul 15;10(7):e0130281. doi: 10.1371/journal.pone.0130281. eCollection 2015.
PubMed 26176621First MB, William JBW, Karg RS, Spitzer RL: Structured Clinical Interview for DSM-5-Research Version (SCID-5 for DSM-5, Research Version; SCRID-5-RV). Arlington,VA, American Psychiatric-Association, 2015.
Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b.
PubMed 2035047Dennis ML, Chan YF, Funk RR. Development and validation of the GAIN Short Screener (GSS) for internalizing, externalizing and substance use disorders and crime/violence problems among adolescents and adults. Am J Addict. 2006;15 Suppl 1(Suppl 1):80-91. doi: 10.1080/10550490601006055.
PubMed 17182423Birchwood M, Smith J, Cochrane R, Wetton S, Copestake S. The Social Functioning Scale. The development and validation of a new scale of social adjustment for use in family intervention programmes with schizophrenic patients. Br J Psychiatry. 1990 Dec;157:853-9. doi: 10.1192/bjp.157.6.853.
PubMed 2289094
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of a Brief, Peer Support Intervention to Facilitate Transition Form Psychiatric Hospitalization
- ClinicalTrials.gov ID
- NCT02946255
- Acronym / sponsor ID
- 073/2016
- Conditions
- Psychosis
- Keywords
- Psychosis, Psychosis NOS, Schizophrenia, Hospital discharge, Inpatient psychiatry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 16 May 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Posted 19 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to examine the effectiveness of a brief intervention that might better facilitate the transition into the community for people with schizophrenia or bipolar disorder with psychotic features. The intervention is called the Welcome Basket. It involves Peer Support Workers connecting with and supporting hospitalized individuals in the days before discharge and again in the community in the first month immediately following discharge. The investigators will compare the outcomes of discharge from hospital as usual with the full version of the welcome basket and a preliminary test of an abbreviated 2 visit version of the intervention.
Detailed description
Discharge from hospital has been highlighted as a critical time in the care of individuals with mental illness. The peak period of risk for readmission for individuals with severe mental illness is in the first month and the highest risk for post-discharge suicide is within the first 2 weeks with discontinuity of contact with providers highlighted as a key risk factor. One half of individuals with schizophrenia miss their first-scheduled outpatient appointment following discharge and this time is a key period of risk for medication non-compliance. Common problems that occur at the time of discharge from psychiatric care settings include poor communication between inpatient and outpatient providers and inadequate involvement and support of families. The research literature on effective practices linked with discharge is strikingly sparse given the evidence that this is a period of heightened risk.
The investigators hypothesize that the Welcome Basket intervention will improve the discharge-related outcomes of individuals with schizophrenia or bipolar disorder with psychotic features compared to treatment as usual. Investigators will also explore the outcomes of an abbreviated, 2-visit version of the intervention. This study will employ a randomized, controlled trial design. Inpatient clients with a diagnosis of schizophrenia spectrum mental illness or bipolar disorder with psychotic features will be randomized with a 2:2:1 ratio to: treatment as usual, the full welcome basket intervention, and the abbreviated intervention. Measures will include re-hospitalization, symptomatology, quality of life, and community functioning. Assessments at baseline, 4 weeks post-discharge, and 6 months post-discharge will facilitate studies of relative effectiveness and sustainment of gains. This design will facilitate an examination of both overall outcomes as well as some preliminary dismantling of mechanisms of action.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Welcome Basket Brief (WBbr) | Experimental | Behavioral: Welcome Basket Brief (WBbr)The brief version of the Welcome Basket (WBbr) was developed based upon the observation in feasibility testing that for some participants much of the benefit of this approach appeared to be centred upon the visits immediately prior and subsequent to discharge. In the WBbr the same core components will be present, albeit in an abbreviated form with one 30-60 minute visit in the week prior to discharge and a single, 3-hour visit in the week subsequent to discharge in which the welcome basket would be delivered, core CAT strategies discussed and implemented, and some basic orientation to community resources undertaken. This brief version of the intervention has not to date been studied. |
| Welcome Basket (WB) | Experimental | Behavioral: Welcome Basket (WB)Peer Support Workers (PSWs) hold 1-2 meetings with clients (30-60 minutes) in the 2-week period before they are discharged from hospital. They describe the program and undertake an assessment. From this assessment the two core components of the intervention are initiated. First, a "welcome basket" is created for the client. The PSW also forms a plan with the client about tours of their neighbourhood to familiarize them with the local resources and support them in building confidence in accessing their local communities. These activities will take place through weekly visits (2 hours/visit) in the 4 weeks immediately following discharge. WB will be provided in combination with core Cognitive Adaptation Training (CAT) compensatory interventions. |
| Treatment As Usual | Active comparator | Behavioral: Treatment As UsualTreatment as usual (TAU) involves the typical discharge procedures for clients from Unit 2, Forensic and EPU wards at CAMH. It includes referral to outpatient psychiatric services and relevant community supports with the transition facilitated by inpatient social work staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants will be adults, 18 years of age or older, with a chart diagnosis of a schizophrenia spectrum mental illness or bipolar disorder with psychotic features confirmed by Module B (psychotic symptoms) of the Structured Clinical Interview for DSM-5 (SCID-5) (First, William, Karg, \& Spitzer, 2015). All participants will be on CAMH inpatient units at the time of recruitment and will have been in continuous inpatient care for close to or more than 2 weeks. This timeframe is guided by the rationale and experience indicating that an overly brief period of hospitalization circumscribes the relevance of the intervention.
- Participants will be returning to places of residence in the Greater Toronto Area (catchment of CAMH) or can travel to the GTA if they will reside outside the catchment area.
- Participants must have been referred to outpatient case management.
- Proposed housing arrangements must be stable and conducive to the intervention. If homelessness or emergency shelter residence appears likely, or boarding home policy precludes any external staff from entering the premises, such individuals will be excluded.
- Proficiency in English.
Key exclusion criteria (1 listed)
- 1. Do not meet the above criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Welcome Basket (WB)Peer Support Workers (PSWs) hold 1-2 meetings with clients (30-60 minutes) in the 2-week period before they are discharged from hospital. They describe the program and undertake an assessment. From this assessment the two core components of the intervention are initiated. First, a "welcome basket" is created for the client. The PSW also forms a plan with the client about tours of their neighbourhood to familiarize them with the local resources and support them in building confidence in accessing their local communities. These activities will take place through weekly visits (2 hours/visit) in the 4 weeks immediately following discharge. WB will be provided in combination with core Cognitive Adaptation Training (CAT) compensatory interventions. | Behavioural | Welcome Basket (WB) |
| Welcome Basket Brief (WBbr)The brief version of the Welcome Basket (WBbr) was developed based upon the observation in feasibility testing that for some participants much of the benefit of this approach appeared to be centred upon the visits immediately prior and subsequent to discharge. In the WBbr the same core components will be present, albeit in an abbreviated form with one 30-60 minute visit in the week prior to discharge and a single, 3-hour visit in the week subsequent to discharge in which the welcome basket would be delivered, core CAT strategies discussed and implemented, and some basic orientation to community resources undertaken. This brief version of the intervention has not to date been studied. | Behavioural | Welcome Basket Brief (WBbr) |
| Treatment As UsualTreatment as usual (TAU) involves the typical discharge procedures for clients from Unit 2, Forensic and EPU wards at CAMH. It includes referral to outpatient psychiatric services and relevant community supports with the transition facilitated by inpatient social work staff. | Behavioural | Treatment As Usual |
Primary outcome
Multnomah Community Ability Scale - Participant Interview Based
Time frame: Baseline
Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.
Multnomah Community Ability Scale - Participant Interview Based
Time frame: 4 Week Follow-Up
Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.
Multnomah Community Ability Scale - Participant Interview Based
Time frame: 6 Month Follow-Up
Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.
Multnomah Community Ability Scale - Clinician Based
Time frame: Baseline
Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.
Multnomah Community Ability Scale - Clinician Based
Time frame: 4 Week Follow-Up
Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.
Multnomah Community Ability Scale - Clinician Based
Time frame: 6 Month Follow-Up
Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.
17 secondary outcomes
Hospitalizations and Emergency Room Visits
Time frame: Baseline to 6 Month Follow-Up
The Satisfaction With Life Scale
Time frame: 4 Week Follow-Up
The Satisfaction With Life Scale
Time frame: 6 Month Follow-Up
Social Support Survey
Time frame: Baseline
Social Support Survey
Time frame: 4 Week Follow-Up
Social Support Survey
Time frame: 6 Month Follow-Up
Brief Symptom Inventory
Time frame: Baseline
Brief Symptom Inventory
Time frame: 4 Week Follow-Up
Brief Symptom Inventory
Time frame: 6 Month Follow-Up
Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale
Time frame: Baseline
Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale
Time frame: 4 Week Follow-Up
Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale
Time frame: 6 Month Follow-Up
Personal Recovery Outcome Measure
Time frame: Baseline
Personal Recovery Outcome Measure
Time frame: 4 Week Follow-Up
Personal Recovery Outcome Measure
Time frame: 6 Month Follow-Up
Community Integration Scale
Time frame: 4 Week Follow-Up
Community Integration Scale
Time frame: 6 Month Follow-Up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7956112Barker S, Barron N, McFarland BH, Bigelow DA. A community ability scale for chronically mentally ill consumers: Part I. Reliability and validity. Community Ment Health J. 1994 Aug;30(4):363-83. doi: 10.1007/BF02207489.
- BackgroundLee, K., Brekke, J., Yamada, A., & Chou, C. (2010). Longitudinal invariance of the satisfaction with life scale for individuals with schizophrenia. Research on Social Work Practice, 20(2), 234-241.
- BackgroundDerogatis, L.R.(1993). BSI Brief Symptom Inventory: Administration, Scoring, and Procedure Manual (4th Ed.). Minneapolis, MN: National Computer Systems.
- BackgroundBarbic, S., Kidd, SA, Backman, C., MacEwan, W.. Honer, W., & McKenzie, K. (2016). The development and testing of the Personal Recovery Outcome Measure (PROM) [in preparation].
- Background: PubMed 26176621Stergiopoulos V, Gozdzik A, Misir V, Skosireva A, Connelly J, Sarang A, Whisler A, Hwang SW, O'Campo P, McKenzie K. Effectiveness of Housing First with Intensive Case Management in an Ethnically Diverse Sample of Homeless Adults with Mental Illness: A Randomized Controlled Trial. PLoS One. 2015 Jul 15;10(7):e0130281. doi: 10.1371/journal.pone.0130281. eCollection 2015.
- BackgroundFirst MB, William JBW, Karg RS, Spitzer RL: Structured Clinical Interview for DSM-5-Research Version (SCID-5 for DSM-5, Research Version; SCRID-5-RV). Arlington,VA, American Psychiatric-Association, 2015.
- Background: PubMed 2035047Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b.
- Background: PubMed 17182423Dennis ML, Chan YF, Funk RR. Development and validation of the GAIN Short Screener (GSS) for internalizing, externalizing and substance use disorders and crime/violence problems among adolescents and adults. Am J Addict. 2006;15 Suppl 1(Suppl 1):80-91. doi: 10.1080/10550490601006055.
- Background: PubMed 2289094Birchwood M, Smith J, Cochrane R, Wetton S, Copestake S. The Social Functioning Scale. The development and validation of a new scale of social adjustment for use in family intervention programmes with schizophrenic patients. Br J Psychiatry. 1990 Dec;157:853-9. doi: 10.1192/bjp.157.6.853.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addictions teachings hospital.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean A Kidd, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Welcome Basket (WB), Welcome Basket Brief (WBbr) and Treatment As Usual in people with Psychosis, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multnomah Community Ability Scale - Participant Interview Based (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02946255, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.