Mental DisordersNCT00375167
Efficacy of the Recovery Workbook as a Psychoeducational Tool for Facilitating Recovery
A study testing Recovery Workbook Training (psychoeducational training) and ACT as usual in people with Mental Disorders, run by Queen's University at 1 site in Canada.
Trial summary
The present study will determine if Spaniol and colleague's (1994) Recovery Workbook group intervention is an effective clinical tool to move a person with SMI along in their journey of recovery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Recovery Workbook Training (psychoeducational training) and ACT as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to May 2007
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Receive support from an Assertive Community Treatment Team.
- Meet the DSM-IV diagnostic classification for schizophrenia, schizoaffective, schizophreniform, delusional disorder, or bipolar disorder.
- Aged 18-55 years-old.
- Individuals agree to participate in the study after they have been informed of all the expected benefits and risks.
- Neither substance misuse nor organic disorder judged to be the major cause of psychotic symptoms.
Who cannot join
- Inability to give informed consent
- Diagnosis of dementia
- Significant head injury or other brain injury leading to cognitive impairment
- Mental retardation (premorbid IQ < 65)
- Require an interpreter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Recovery Workbook as a Psychoeducational Tool for Facilitating Recovery in Persons With Severe and Persistent Mental Illness
The present study will determine if Spaniol and colleague's (1994) Recovery Workbook group intervention is an effective clinical tool to move a person with SMI along in their journey of recovery. The primary outcome measurements of this study will be the participants' perceived level of empowerment, hope and optimism, knowledge of recovery, and life satisfaction. This kind of information would add to the current body of knowledge about how principles of recovery can be used in psychoeducational programs used by outpatient community mental health services.
Read the detailed description
ABSTRACT:
Objective: Adopting the principles of recovery into the mental health field has been a growing area for discussion at many different levels of care. The present study will determine if Spaniol and colleague's (1994) Recovery Workbook group intervention can be used as an effective clinical tool to move a person with a severe mental illness along in their journey of recovery. The primary outcome measurements of this study will be the participants' perceived level of empowerment, hope and optimism, knowledge of recovery, and life satisfaction. Method: The study will be a multicenter, prospective, single-blinded, randomized control trial. Sixty participants will be recruited from three Assertive Community Treatment Teams (ACTT) in Kingston, Ontario and individuals will be randomized to either the control or intervention arm of the study. The control arm of the study will receive their regular services from ACTT. The intervention arm will participate in a 10-week psychoeducational group program in addition to receiving their regular services from ACTT. Results: Analysis will be performed by intention to treat, based on total scores of four assessments which will be performed at the trial commencement and termination.
- Conditions
- Mental Disorders
- Being tested
- Recovery Workbook Training (psychoeducational training), ACT as usual
- Keywords
- Recovery, Hope, Empowerment, Randomized Control Trial
- Medical subject headings
- Mental Disorders, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery Workbook Training (psychoeducational training)Behavioural
The Recovery Workbook uses an educational process to increase awareness of recovery, increase knowledge and control of the illness, increase awareness of the importance and nature of stress, enhance personal meaning, build personal support, and develop goals and plans of action. The intervention period of 30 weekly sessions recommended by Spaniol and colleagues was shortened to 12 weekly sessions to accommodate for clinical and participant commitment. No workbook content was excluded, and all practice exercises were covered.
ACT as usualBehavioural
Assertive Community Treatment services provided as per established and evidence-based fidelity standards.
| Study group | Role | What they receive |
|---|---|---|
| Recovery Workbook Intervention | Experimental | 12-week Recovery Intervention: The intervention is a 12-week group-based intervention. The intervention is informed by the Recovery Workbook- a validated intervention for people with serious mental illness. The intervention includes 2 hour sessions for 12 weeks that focus on the following areas: Introduction to the intervention; Recovery; Knowledge and Control; Managing life stress; Enhancing personal meaning; Building personal support; and Setting personal goals. The total time period of the intervention is 24 hours. Participants in this arm also receive treatment as usual. Receives: Behavioral: Recovery Workbook Training (psychoeducational training); Behavioral: ACT as usual |
| Treatment as usual | No intervention | The participants in the control arm will continue to receive treatment as usual. TAU is Assertive Community Treatment. Assertive Community Treatments are structured to meet set fidelity standards that are evidence-based. This arm did not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hope Herth Index
The Herth Hope Index was used to gather information about participants' level of hopefulness. The 12-item scale is easily administered and has been used with persons with serious mental illness . It is a self-report tool, and respondents answer on a 4-point agreement scale that ranges from "strongly disagree" to "strongly agree". The scoring range is from 12-48 with a higher score indicating higher levels of hope. The scale has been shown to have an alpha coefficient of .97 and a test-retest reliability of .91 within two weeks. Criterion-related validity has also been supported by high correlations (.81-.92) with instruments measuring the same construct.
Measured: Within 3 days of completion of intervention
Empowerment Scale
The construct measured is empowerment. The Empowerment Scale is a self-reported measure that contains 28 statements about empowerment to which participants respond on a 4-point agreement scale. Scoring range is 28-112, with a lower score indicating higher empowerment. Studies have demonstrated the scale's high internal consistency ({alpha}=.85-.90) and good reliability ({alpha}>.60) and validity (28,31,32).
Measured: Within 3 days of completion of interventions
Recovery Assessment Scale
The construct is Personal Recovery, defined as a person's ability to live a full and meaningful life. The Recovery Assessment Scale (RAS) has 41-items and uses a 5-point agreement scale, and a total score is used, with scores ranging from 41-205, with a higher score indicating a higher sense of personal recovery. The RAS also has 5 subscales (see below). Subscales are added to produce a total score. Domain 1 is Confidence and Hope. he scoring range here is 9-45, where a higher score indicating higher recovery. Domain 2 is Willingness to Ask for Help. Scoring range is 3-15. Domain 3: Ability rely on others: Scoring range 5-25. Domain 4 Symptoms: Scoring range 4-20. Domain 5: Goal and Success Orientation: Scoring range 3-15. For each domain, higher values represent a better outcome.
Measured: Within 3 days of completion of intervention
Quality of Life Index, General Version
The Quality of Life Index, General Version (37), is a 33-item self-report scale measuring satisfaction with and importance of aspects of life. It includes four subscales: health and functioning, socioeconomic status, psychological status, and significant others. Satisfaction and importance are measured on a 6-point agreement scale. A high score indicates higher quality of life. Full scoring instructions and computer algorithm is available at http://qli.org.uic.edu/questionaires/pdf/genericversionIII/genericscoring.pdf. Importance ratings are used to weight satisfaction responses so that scores reflect satisfaction with aspects of life that are valued by the individual (37). For internal consistency and reliability, Cronbach's alpha is .92 for the entire tool and .88, .75, .80, and .68, respectively, for the subscales (37). Possible range for the final scores = 0 to 30, where a higher value represents a better outcome..
Measured: Within 3 days of completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionJan 2007
- Study completionMay 2007
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.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Terry Krupa, Queen's University
- Investigators
- Skye Barbic, BScOT, Principal investigator, Queen's UniversityTerry Krupa, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375167
- Sponsor's protocol ID
- 1
- Status last verified
- Nov 2018
- First submitted
- 11 Sep 2006
- Last updated
- 6 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Recovery Workbook as a Psychoeducational Tool for Facilitating Recovery in Persons With Severe and Persistent Mental Illness
- ClinicalTrials.gov ID
- NCT00375167
- Acronym / sponsor ID
- 1
- Conditions
- Mental Disorders
- Keywords
- Recovery, Hope, Empowerment, Randomized Control Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 12 Sep 2006 (estimated)
- Results
- Posted 6 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study will determine if Spaniol and colleague's (1994) Recovery Workbook group intervention is an effective clinical tool to move a person with SMI along in their journey of recovery. The primary outcome measurements of this study will be the participants' perceived level of empowerment, hope and optimism, knowledge of recovery, and life satisfaction. This kind of information would add to the current body of knowledge about how principles of recovery can be used in psychoeducational programs used by outpatient community mental health services.
Detailed description
ABSTRACT:
Objective: Adopting the principles of recovery into the mental health field has been a growing area for discussion at many different levels of care. The present study will determine if Spaniol and colleague's (1994) Recovery Workbook group intervention can be used as an effective clinical tool to move a person with a severe mental illness along in their journey of recovery. The primary outcome measurements of this study will be the participants' perceived level of empowerment, hope and optimism, knowledge of recovery, and life satisfaction. Method: The study will be a multicenter, prospective, single-blinded, randomized control trial. Sixty participants will be recruited from three Assertive Community Treatment Teams (ACTT) in Kingston, Ontario and individuals will be randomized to either the control or intervention arm of the study. The control arm of the study will receive their regular services from ACTT. The intervention arm will participate in a 10-week psychoeducational group program in addition to receiving their regular services from ACTT. Results: Analysis will be performed by intention to treat, based on total scores of four assessments which will be performed at the trial commencement and termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recovery Workbook Intervention | Experimental | Behavioral: Recovery Workbook Training (psychoeducational training), Behavioral: ACT as usual12-week Recovery Intervention: The intervention is a 12-week group-based intervention. The intervention is informed by the Recovery Workbook- a validated intervention for people with serious mental illness. The intervention includes 2 hour sessions for 12 weeks that focus on the following areas: Introduction to the intervention; Recovery; Knowledge and Control; Managing life stress; Enhancing personal meaning; Building personal support; and Setting personal goals. The total time period of the intervention is 24 hours. Participants in this arm also receive treatment as usual. |
| Treatment as usual | No intervention | –The participants in the control arm will continue to receive treatment as usual. TAU is Assertive Community Treatment. Assertive Community Treatments are structured to meet set fidelity standards that are evidence-based. This arm did not receive any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Receive support from an Assertive Community Treatment Team.
- Meet the DSM-IV diagnostic classification for schizophrenia, schizoaffective, schizophreniform, delusional disorder, or bipolar disorder.
- Aged 18-55 years-old.
- Individuals agree to participate in the study after they have been informed of all the expected benefits and risks.
- Neither substance misuse nor organic disorder judged to be the major cause of psychotic symptoms.
Key exclusion criteria (5 listed)
- Inability to give informed consent
- Diagnosis of dementia
- Significant head injury or other brain injury leading to cognitive impairment
- Mental retardation (premorbid IQ < 65)
- Require an interpreter
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 |
|---|---|---|
| Recovery Workbook Training (psychoeducational training)The Recovery Workbook uses an educational process to increase awareness of recovery, increase knowledge and control of the illness, increase awareness of the importance and nature of stress, enhance personal meaning, build personal support, and develop goals and plans of action. The intervention period of 30 weekly sessions recommended by Spaniol and colleagues was shortened to 12 weekly sessions to accommodate for clinical and participant commitment. No workbook content was excluded, and all practice exercises were covered. | Behavioural | Recovery Workbook Intervention |
| ACT as usualAssertive Community Treatment services provided as per established and evidence-based fidelity standards. | Behavioural | Recovery Workbook Intervention |
Primary outcome
Hope Herth Index
Time frame: Within 3 days of completion of intervention
The Herth Hope Index was used to gather information about participants' level of hopefulness. The 12-item scale is easily administered and has been used with persons with serious mental illness . It is a self-report tool, and respondents answer on a 4-point agreement scale that ranges from "strongly disagree" to "strongly agree". The scoring range is from 12-48 with a higher score indicating higher levels of hope. The scale has been shown to have an alpha coefficient of .97 and a test-retest reliability of .91 within two weeks. Criterion-related validity has also been supported by high correlations (.81-.92) with instruments measuring the same construct.
Empowerment Scale
Time frame: Within 3 days of completion of interventions
The construct measured is empowerment. The Empowerment Scale is a self-reported measure that contains 28 statements about empowerment to which participants respond on a 4-point agreement scale. Scoring range is 28-112, with a lower score indicating higher empowerment. Studies have demonstrated the scale's high internal consistency ({alpha}=.85-.90) and good reliability ({alpha}>.60) and validity (28,31,32).
Recovery Assessment Scale
Time frame: Within 3 days of completion of intervention
The construct is Personal Recovery, defined as a person's ability to live a full and meaningful life. The Recovery Assessment Scale (RAS) has 41-items and uses a 5-point agreement scale, and a total score is used, with scores ranging from 41-205, with a higher score indicating a higher sense of personal recovery. The RAS also has 5 subscales (see below). Subscales are added to produce a total score. Domain 1 is Confidence and Hope. he scoring range here is 9-45, where a higher score indicating higher recovery. Domain 2 is Willingness to Ask for Help. Scoring range is 3-15. Domain 3: Ability rely on others: Scoring range 5-25. Domain 4 Symptoms: Scoring range 4-20. Domain 5: Goal and Success Orientation: Scoring range 3-15. For each domain, higher values represent a better outcome.
Quality of Life Index, General Version
Time frame: Within 3 days of completion of intervention
The Quality of Life Index, General Version (37), is a 33-item self-report scale measuring satisfaction with and importance of aspects of life. It includes four subscales: health and functioning, socioeconomic status, psychological status, and significant others. Satisfaction and importance are measured on a 6-point agreement scale. A high score indicates higher quality of life. Full scoring instructions and computer algorithm is available at http://qli.org.uic.edu/questionaires/pdf/genericversionIII/genericscoring.pdf. Importance ratings are used to weight satisfaction responses so that scores reflect satisfaction with aspects of life that are valued by the individual (37). For internal consistency and reliability, Cronbach's alpha is .92 for the entire tool and .88, .75, .80, and .68, respectively, for the subscales (37). Possible range for the final scores = 0 to 30, where a higher value represents a better outcome..
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Skye Barbic, BScOT principal investigator
Queen's University
Terry Krupa, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Workbook Training (psychoeducational training) and ACT as usual in people with Mental Disorders, run by Queen's University 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 5 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 6 Mar 2019. 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 6 Mar 2019). 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?
Hope Herth Index (time frame: Within 3 days of completion of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.