Psychotic DisordersEarly Phase 1ACT-IPNCT01981356
Acceptance and Commitment Therapy for the Inpatient Treatment of Psychosis
A Early Phase 1 study testing Acceptance and Commitment Therapy and Treatment as Usual (TAU) in people with Psychotic Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial summary
There is a substantial need for enhancing the efficacy and effectiveness of Veterans Health Administration (VHA) inpatient services for psychosis and tailoring them to support recovery. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Acceptance and Commitment Therapy and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Apr 2015
- Phase
- Early Phase 1
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria for the patient sample, used to establish feasibility, acceptability, safety, and efficacy of the experimental treatment, will be:
- hospitalized with current psychosis symptoms (hallucinations and/or delusions);
- DSM-IV-TR (APA, 2000) diagnosis of a psychotic disorder (i.e., schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, brief psychotic disorder, psychotic disorder not otherwise specified) or a mood disorder with psychotic features (major depression, bipolar I disorder) that requires hospitalization;
- ability to provide informed consent ;
- conversational in English; and
- patient stay on the unit estimated in advance to be greater than one week.
Show all 9Show fewer
- Inclusion criteria for the staff sample, used to identify barriers and facilitators to the implementation of the experimental treatment, will be
- ability to provide informed consent and
- conversational in English.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
About this study
There is a substantial need for enhancing the efficacy and effectiveness of Veterans Health Administration (VHA) inpatient services for psychosis and tailoring them to support recovery. The proposed pilot study will explore whether Acceptance and Commitment Therapy (ACT), a recovery-oriented, evidence-based inpatient treatment, is a feasible, acceptable, safe, and effective adjunct for the inpatient treatment of Veterans with psychosis at a single VHA site. Additionally, an evaluation of barriers and facilitators to future implementation will be conducted. If promising, the data gained from the proposed study will support future evaluation, implementation and dissemination efforts that have the potential to improve inpatient treatment for psychosis and recovery, and thus, the lives of Veterans, while reducing costs for VHA.
Read the detailed description
Within the Veterans Health Administration (VHA) in fiscal year 2011, patients with psychotic disorders represented approximately 4% of the total population, and received approximately 14% of VHA's total expenditures (Blow et al., 2011). Patients with psychosis receive substantial, repeated, and costly inpatient treatment, and this is often the only chance to provide treatment due to gaps in mental health service utilization (Blow et al., 2011; McCarthy et al., 2007). Thus, there is an urgent need for enhancing the efficacy and effectiveness of VHA inpatient services and tailoring them to better support recovery.
Acceptance and Commitment Therapy (ACT), a recovery-oriented, evidence-based adjunct to inpatient treatment for psychosis, is an excellent candidate for investigations within VHA inpatient settings. ACT for psychosis is considered an empirically supported treatment by the American Psychological Association (APA, 2012; Chambless et al., 1998). A consistent body of research has demonstrated the clinical effectiveness of ACT for treatment of psychosis, including well-designed randomized clinical trials of ACT on inpatient settings (Bach \& Hayes, 2000; Gaudiano \& Herbert, 2006). ACT is effective when provided in a flexible format of three to four sessions, and for patients with a range of chronic and severe psychotic and comorbid mental disorders.
This proposed pilot study aims to explore ACT as an adjunct to inpatient treatment as usual (TAU) for psychosis among VHA patients at one VHA inpatient psychiatry unit. The project will use an effectiveness/ implementation Hybrid Type 1 design that incorporates a pilot RCT and semi-formative evaluation of barriers and facilitators to future implementation. Participants will be 80 VHA patients with current psychotic symptoms (hallucinations and/or delusions) related to a psychotic or mood disorder who are admitted to an inpatient psychiatry unit VA Palo Alto Health Care System (VAPAHCS). Participants will be randomly assigned to receive either TAU (n = 40), or TAU with plus 4-sessions of ACT (n = 40) individually provided during their stay on the inpatient unit. Aim 1 is to investigate the feasibility, acceptability, and safety of the treatment for VHA patients, as indexed by: (a) the ability to recruit and consent 2 eligible participants per week (for 40 weeks) to participate in the study and be randomized to ACT + TAU or TAU; (b) patient attendance of 3 ACT individual sessions (out of 4 possible) on average; (c) patient and ACT Facilitator (provider of the intervention), reported ACT treatment satisfaction and alliance; and (d) the occurrence of zero serious adverse events attributable to the ACT treatment. Aim 2 is to investigate treatment effects of ACT on patient functioning (i.e., acceptance), symptomatology, distress, and affect. Aim 3 is to obtain data from participating patients and unit staff regarding system-, clinician- and patient-level barriers and facilitators to implementing staff-delivered ACT services for psychosis at the participating VHA inpatient setting, including: (a) barriers that limit patients, staff, and site participation in ACT and how to address them; (b) provider and patient perceptions about why ACT is successful at achieving better outcomes; (c) site specific and general barriers to implementation of ACT and how to address them; and (d) perceived value of and how to sustain ACT in the absence of a funded project.
This project is the first step in exploring a potentially sustainable and effective intervention that will improve inpatient psychosis treatment and recovery, and hence, the lives of VHA patients with psychosis, while reducing costs for VHA. If promising, study findings will support a HSR\&D Investigator Initiated Research (IIR) Merit grant application that will propose to assess the effectiveness and cost of implementing the ACT intervention, and potential barriers and facilitators for implementation efforts at multiple VHA inpatient psychiatric units. The aims of this project align with the HSR\&D research priority area of improving mental and behavioral interventions for individuals with serious mental illness by refining recovery-oriented treatment approaches related to evidence-based programs.
- Conditions
- Psychotic Disorders
- Being tested
- Acceptance and Commitment Therapy, Treatment as Usual (TAU)
- Keywords
- Psychotic Disorders, Acceptance and Commitment Therapy, Inpatient psychiatry, Schizophrenia, Acute psychiatric disorder
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Also called ACT
The goal of ACT is to help the patient increase psychological flexibility, a core component of mental health and well-being. ACT teaches clients to be mindfully aware but nonreactive to delusions/ hallucinations and to increase willingness to
experience associated distressing emotions while simultaneously engaging in meaningful behavioral actions.
Patients expand their repertoire of behaviors to live according to their values and to pursue valued goals, thereby increasing adaptive functioning and quality of life.
All patients admitted to the acute psychiatry unit are administered anti-psychotic and/or other psychotropic medication during their inpatient stay. Patients participate in standard milieu therapy on the unit (group and activities therapies, and individual therapy as needed). Therapy on the unit focuses on psycho-education about illness, symptom identification, mood management techniques, stress reduction, and relapse prevention. Patients also receive unstructured individual therapy and case management as appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Experimental | Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions. The treatment protocol is adapted from and virtually identical to that presented in Gaudiano and Herbert (2006). Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Participants in the ACT condition will also receive treatment as usual. Receives: Behavioral: Acceptance and Commitment Therapy |
| Treatment as Usual (TAU) | Active comparator | TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Psychiatric Rating Scale (Overall & Gorham, 1962)
Assesses changes in broad symptom domains (affect disturbance, positive symptoms, negative symptoms, resistance/hostility, activation) and specific symptoms (e.g., delusions). All scale items were averaged to obtain a total scale score. Scale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest (7) to lowest (1) possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest (1) to highest (7) possible value on scale from baseline to follow-up. Decreases in percentage change are considered better outcomes (i.e., reduced symptoms).
Measured: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Secondary outcomes (10)
Frequency, Believability, and Distress Symptom Scale (Gaudiano & Herbert, 2006)
Assesses changes in the frequency, believability, and associated distress of psychosis symptoms. Frequency, believability, and distress subscales consist of two items each, one assessing delusions and one assessing hallucinations, averaged to obtain subscale scores. Subscale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest to lowest possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest to highest possible value on scale from baseline to follow-up. Decreases in percentage change are considered better outcomes (i.e., reduced frequency, believability and distress).
Measured: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Acceptance and Action Questionnaire - II (Bond et al.., 2011)
Assesses changes in the primary mechanism thought to contribute to change in ACT: acceptance. All scale items were averaged to obtain a total scale score. Total scale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest (7) to lowest (1) possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest (1) to highest (7) possible value on scale from baseline to follow-up. Increases in percentage change are considered better outcomes (i.e., increased acceptance).
Measured: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Positive and Negative Affect Scale (Watson et al., 1988)
Assesses short-term changes in global positive and negative affect in addition to changes in specific types of emotions (e.g., afraid, excited, guilty). Positive and negative affect subscales consist of ten items each, averaged to obtain scale scores. Scale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest (5) to lowest (1) possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest (1) to highest (5) possible value on scale from baseline to follow-up. Increases in positive affect percentage change and decreases in negative affect change are considered better outcomes.
Measured: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Cost of Stay
Obtained by: (a) obtaining length obtained by: (a) obtaining length-of-stay (in hours) on the inpatient unit for all study participants, (b) calculating the cost of stay for each participant by multiplying the length-of-stay by the dollar amount associated with inpatient treatment of psychosis (e.g., $1,297/day or $54/hour in 2011; Blow et al., 2011), and (c) summing the cost of stay across participants in each treatment condition.
Measured: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Barriers and Facilitators to Implementation
We will conduct 30-60 minute semi-structured interviews structured around the RE-AIM framework (Glasgow et al., 1999), and utilizing the RE-AIM Planning Tool (Forman et al., 2010). The RE-AIM framework identifies, for example, barriers that limit patients, staff, and site participation in the intervention and how to address them, and provider and patient perceptions about why the intervention is successful at achieving better outcomes.
Measured: 8-month study period
Experimental Treatment Feasibility
Assessed by our ability to recruit and consent 2 eligible participants per week (for 40 weeks) to participate in random assignment to ACT + TAU or TAU.
Measured: 8-month study period
Experimental Treatment Acceptability
Assessed by patient attendance of at least 3 out of 4 sessions on average.
Measured: 8-month study period
Experimental Treatment Safety
Assessed by the occurrence of zero adverse events attributable to ACT.
Measured: 8-month study period
Experimental Treatment Acceptability
Assessed by patient reported treatment satisfaction, as assessed by the well-validated Client Satisfaction Questionnaire - 8 (CSQ-8; Attkisson \& Zwick, 1982; range 0 to 5, higher scores indicate better outcome).
Measured: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Experimental Treatment Acceptability
Assessed by patient reported therapeutic alliance, measured by the well-validated Working Alliance Inventory (WAI; Horvath \& Greenberg, 1989; range 1 to 7, higher score indicated better outcome).
Measured: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startSep 2014
- Primary completionApr 2015
- Study completionApr 2015
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 Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Matthew T Boden, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981356
- Sponsor's protocol ID
- PPO 13-132
- Acronym
- ACT-IP
- Status last verified
- Apr 2016
- First submitted
- 4 Nov 2013
- Last updated
- 14 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy for the Inpatient Treatment of Psychosis
- ClinicalTrials.gov ID
- NCT01981356
- Acronym / sponsor ID
- ACT-IP / PPO 13-132
- Conditions
- Psychotic Disorders
- Keywords
- Psychotic Disorders, Acceptance and Commitment Therapy, Inpatient psychiatry, Schizophrenia, Acute psychiatric disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Sep 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Posted 14 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a substantial need for enhancing the efficacy and effectiveness of Veterans Health Administration (VHA) inpatient services for psychosis and tailoring them to support recovery. The proposed pilot study will explore whether Acceptance and Commitment Therapy (ACT), a recovery-oriented, evidence-based inpatient treatment, is a feasible, acceptable, safe, and effective adjunct for the inpatient treatment of Veterans with psychosis at a single VHA site. Additionally, an evaluation of barriers and facilitators to future implementation will be conducted. If promising, the data gained from the proposed study will support future evaluation, implementation and dissemination efforts that have the potential to improve inpatient treatment for psychosis and recovery, and thus, the lives of Veterans, while reducing costs for VHA.
Detailed description
Within the Veterans Health Administration (VHA) in fiscal year 2011, patients with psychotic disorders represented approximately 4% of the total population, and received approximately 14% of VHA's total expenditures (Blow et al., 2011). Patients with psychosis receive substantial, repeated, and costly inpatient treatment, and this is often the only chance to provide treatment due to gaps in mental health service utilization (Blow et al., 2011; McCarthy et al., 2007). Thus, there is an urgent need for enhancing the efficacy and effectiveness of VHA inpatient services and tailoring them to better support recovery.
Acceptance and Commitment Therapy (ACT), a recovery-oriented, evidence-based adjunct to inpatient treatment for psychosis, is an excellent candidate for investigations within VHA inpatient settings. ACT for psychosis is considered an empirically supported treatment by the American Psychological Association (APA, 2012; Chambless et al., 1998). A consistent body of research has demonstrated the clinical effectiveness of ACT for treatment of psychosis, including well-designed randomized clinical trials of ACT on inpatient settings (Bach \& Hayes, 2000; Gaudiano \& Herbert, 2006). ACT is effective when provided in a flexible format of three to four sessions, and for patients with a range of chronic and severe psychotic and comorbid mental disorders.
This proposed pilot study aims to explore ACT as an adjunct to inpatient treatment as usual (TAU) for psychosis among VHA patients at one VHA inpatient psychiatry unit. The project will use an effectiveness/ implementation Hybrid Type 1 design that incorporates a pilot RCT and semi-formative evaluation of barriers and facilitators to future implementation. Participants will be 80 VHA patients with current psychotic symptoms (hallucinations and/or delusions) related to a psychotic or mood disorder who are admitted to an inpatient psychiatry unit VA Palo Alto Health Care System (VAPAHCS). Participants will be randomly assigned to receive either TAU (n = 40), or TAU with plus 4-sessions of ACT (n = 40) individually provided during their stay on the inpatient unit. Aim 1 is to investigate the feasibility, acceptability, and safety of the treatment for VHA patients, as indexed by: (a) the ability to recruit and consent 2 eligible participants per week (for 40 weeks) to participate in the study and be randomized to ACT + TAU or TAU; (b) patient attendance of 3 ACT individual sessions (out of 4 possible) on average; (c) patient and ACT Facilitator (provider of the intervention), reported ACT treatment satisfaction and alliance; and (d) the occurrence of zero serious adverse events attributable to the ACT treatment. Aim 2 is to investigate treatment effects of ACT on patient functioning (i.e., acceptance), symptomatology, distress, and affect. Aim 3 is to obtain data from participating patients and unit staff regarding system-, clinician- and patient-level barriers and facilitators to implementing staff-delivered ACT services for psychosis at the participating VHA inpatient setting, including: (a) barriers that limit patients, staff, and site participation in ACT and how to address them; (b) provider and patient perceptions about why ACT is successful at achieving better outcomes; (c) site specific and general barriers to implementation of ACT and how to address them; and (d) perceived value of and how to sustain ACT in the absence of a funded project.
This project is the first step in exploring a potentially sustainable and effective intervention that will improve inpatient psychosis treatment and recovery, and hence, the lives of VHA patients with psychosis, while reducing costs for VHA. If promising, study findings will support a HSR\&D Investigator Initiated Research (IIR) Merit grant application that will propose to assess the effectiveness and cost of implementing the ACT intervention, and potential barriers and facilitators for implementation efforts at multiple VHA inpatient psychiatric units. The aims of this project align with the HSR\&D research priority area of improving mental and behavioral interventions for individuals with serious mental illness by refining recovery-oriented treatment approaches related to evidence-based programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Experimental | Behavioral: Acceptance and Commitment TherapyParticipants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions. The treatment protocol is adapted from and virtually identical to that presented in Gaudiano and Herbert (2006). Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Participants in the ACT condition will also receive treatment as usual. |
| Treatment as Usual (TAU) | Active comparator | Other: Treatment as Usual (TAU)TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Inclusion criteria for the patient sample, used to establish feasibility, acceptability, safety, and efficacy of the experimental treatment, will be:
- hospitalized with current psychosis symptoms (hallucinations and/or delusions);
- DSM-IV-TR (APA, 2000) diagnosis of a psychotic disorder (i.e., schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, brief psychotic disorder, psychotic disorder not otherwise specified) or a mood disorder with psychotic features (major depression, bipolar I disorder) that requires hospitalization;
- ability to provide informed consent ;
- conversational in English; and
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Acceptance and Commitment TherapyAlso: ACTThe goal of ACT is to help the patient increase psychological flexibility, a core component of mental health and well-being. ACT teaches clients to be mindfully aware but nonreactive to delusions/ hallucinations and to increase willingness to experience associated distressing emotions while simultaneously engaging in meaningful behavioral actions. Patients expand their repertoire of behaviors to live according to their values and to pursue valued goals, thereby increasing adaptive functioning and quality of life. | Behavioural | Acceptance and Commitment Therapy (ACT) |
| Treatment as Usual (TAU)All patients admitted to the acute psychiatry unit are administered anti-psychotic and/or other psychotropic medication during their inpatient stay. Patients participate in standard milieu therapy on the unit (group and activities therapies, and individual therapy as needed). Therapy on the unit focuses on psycho-education about illness, symptom identification, mood management techniques, stress reduction, and relapse prevention. Patients also receive unstructured individual therapy and case management as appropriate. | Other | Treatment as Usual (TAU) |
Primary outcome
Brief Psychiatric Rating Scale (Overall & Gorham, 1962)
Time frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Assesses changes in broad symptom domains (affect disturbance, positive symptoms, negative symptoms, resistance/hostility, activation) and specific symptoms (e.g., delusions). All scale items were averaged to obtain a total scale score. Scale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest (7) to lowest (1) possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest (1) to highest (7) possible value on scale from baseline to follow-up. Decreases in percentage change are considered better outcomes (i.e., reduced symptoms).
10 secondary outcomes
Frequency, Believability, and Distress Symptom Scale (Gaudiano & Herbert, 2006)
Time frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Acceptance and Action Questionnaire - II (Bond et al.., 2011)
Time frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Positive and Negative Affect Scale (Watson et al., 1988)
Time frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Cost of Stay
Time frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Barriers and Facilitators to Implementation
Time frame: 8-month study period
Experimental Treatment Feasibility
Time frame: 8-month study period
Experimental Treatment Acceptability
Time frame: 8-month study period
Experimental Treatment Safety
Time frame: 8-month study period
Experimental Treatment Acceptability
Time frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Experimental Treatment Acceptability
Time frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Psychotic Disorders
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis
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.
Matthew T Boden, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Acceptance and Commitment Therapy and Treatment as Usual (TAU) in people with Psychotic Disorders, run by VA Office of Research and Development at 1 site in United States.
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 9 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 14 Apr 2016. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2016). 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?
Brief Psychiatric Rating Scale (Overall & Gorham, 1962) (time frame: Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).). 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 14 Apr 2016.