SchizophreniaNCT02469389
Improving Negative Symptoms & Community Engagement in Veterans With Schizophrenia
A study testing Engaging in Community Roles and Experiences (ENCoRE) and Health & Wellness (H&W) in people with Schizophrenia and Serious Mental Illness, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The goal of this project is to evaluate an innovative psychosocial intervention package that will incorporate evidence-based treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Schizophrenia, Serious Mental Illness
- What is being tested?
- Engaging in Community Roles and Experiences (ENCoRE) and Health & Wellness (H&W)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2015to 27 May 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic and Statistical Manual of Disorders, 5th edition (DSM 5) diagnosis of schizophrenia or schizoaffective disorder
- A minimum average rating of a "moderately severe deficit" (3 or greater on a 0-4 scale) on one symptom domain or a minimum average rating of a "moderate deficit" (2 or greater on a 0-4 scale) on two or more domains, within the affect motivation factor of the Clinical Assessment Interview for Negative Symptoms (CAINS) i.e.,:
- symptoms of asociality
- avolition
- anhedonia
- Age between 18 and 75 years
- Seen by a service provider twice within the last 6 months or once in the last 6 months consistently for two years, as in line with the Veteran's recorded mental health treatment plan (to demonstrate that participants receive ongoing and regular mental health care)
- Competent to sign Informed Consent
Who cannot join
- Documented history of serious neurological disorder or head trauma with loss of consciousness
- Cognitive impairment (defined as a total intelligence quotient (IQ) score less than 70 as measured by the Wechsler Test of Adult Reading or as indicated by chart review
- Inability to effectively participate in the baseline assessments due to psychiatric symptoms on two successive appointments
- Current problematic substance use as indexed by scores on the Michigan Alcoholism Screening Test and the Drug Abuse Screening Test
- Currently meet criteria for a major depressive episode
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
The goal of this project is to evaluate an innovative psychosocial intervention package that will incorporate evidence-based treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. The intervention - called EnCoRE (Engaging in Community Roles and Experiences) - will include strategies aimed at teaching Veterans with schizophrenia and negative symptoms ways to (1) overcome deficits in anticipatory pleasure, (2) increase intrinsic motivation for goal-directed activities, (3) reduce expectancies for failure, and (4) perform skillfully in new social situations, all of which can impact implementation of new skills and behaviors. Rather than develop a new set of intervention strategies, the investigators will include within EnCoRE evidence-based strategies for these treatment domains. In addition, the investigators will collect qualitative information both from Veterans concerning their perceptions of the strengths, weaknesses, and barriers to participation in EnCoRE, as well as from a sample of mental health providers who work with Veterans with schizophrenia and negative symptoms, in order to inform a larger scale implementation trial should EnCoRE prove effective here.
Read the detailed description
The goal of this study is to evaluate an innovative psychosocial intervention package that will incorporate evidence-based treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. The intervention - called EnCoRE (Engaging in Community Roles and Experiences) - will include strategies aimed at teaching Veterans with schizophrenia and negative symptoms ways to (1) overcome deficits in anticipatory pleasure, (2) increase intrinsic motivation for goal-directed activities, (3) reduce expectancies for failure, and (4) perform skillfully in new social situations, all of which can impact implementation of new skills and behaviors. Rather than develop a new set of intervention strategies, the investigators will include within EnCoRE evidence-based strategies for these treatment domains. In addition, the investigators will collect qualitative information both from Veterans concerning their perceptions of the strengths, weaknesses, and barriers to participation in EnCoRE, as well as from a sample of mental health providers who work with Veterans with schizophrenia and negative symptoms, in order to inform a larger scale implementation trial should EnCoRE prove effective here.
Following a short pilot to train interventionists and refine the manual, the investigators will conduct a randomized controlled trial to test the efficacy of EnCoRE in improving ratings of negative symptoms, functional outcomes, and engagement in community activities in a sample of Veterans with schizophrenia and negative symptoms (n=108). Participants will be randomized either to EnCoRE or a health-related control group. These goals fit well within the objectives of the Rehabilitation Research and Development (RR\&D) program of funding research aimed at studying rehabilitation interventions focused on maximizing functional recovery and assisting in the integration of Veterans into civilian life. Specifically, the investigators will address the following Specific Aims:
Specific Aim 1: Train therapists and refine the EnCoRE manual in a preliminary trial with 10 Veterans with schizophrenia and negative symptoms.
Specific Aim 2: Conduct a randomized controlled trial (n=108, medium effect, alpha=.05) to test the efficacy of EnCoRE in producing positive changes at post-treatment and 3-month follow-up on the primary outcomes of negative symptoms and social and community functioning.
Specific Aim 3: Examine qualitative interviews completed by (1) Veterans who participated in EnCoRE and (2) Mental Health Providers to determine aspects of EnCoRE that were perceived as more or less helpful, interesting, and valuable in order to make adjustments prior to conducting a larger, multi-site implementation trial.
- Conditions
- Schizophrenia, Serious Mental Illness
- Being tested
- Engaging in Community Roles and Experiences (ENCoRE), Health & Wellness (H&W)
- Keywords
- Schizophrenia, Negative Symptoms
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engaging in Community Roles and Experiences (ENCoRE)Behavioural
Also called ENCoRE
Engaging in Community Roles and Experiences (ENCoRE) includes evidence-based psychosocial treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. Behavioral strategies include motivational enhancement, psychoeducation, cognitive therapy, and social skills training.
Health & Wellness (H&W)Behavioural
Also called H&W
Health \& Wellness (H\&W) will focus on health and wellness issues and education on ways to better manage health-related concerns following a basic structure that includes: review of the previous session's material, new educational content, and discussion/application.
Topics will include: 1) Overview, 2) Physical Activity (3 sessions), 3) Nutrition/Healthy Eating (3 sessions), 4) Managing Fatigue/Sleep (3 sessions), 5) Relaxation (3 sessions), 6) Tobacco cessation (3 sessions), 7) Substance Use (3 sessions), 8) Medication/Side Effects (3 sessions), 9) Review (1 session), and Closing (1session).
| Study group | Role | What they receive |
|---|---|---|
| Engaging in Community Roles and Experiences (ENCoRE) | Experimental | Engaging in Community Roles and Experiences (ENCoRE) includes evidence-based psychosocial treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. Behavioral strategies include motivational enhancement, psychoeducation, cognitive therapy, and social skills training. Receives: Behavioral: Engaging in Community Roles and Experiences (ENCoRE) |
| Health & Wellness (H&W) | Active comparator | Health \& Wellness (H\&W) will focus on health and wellness issues and education on ways to better manage health-related concerns following a basic structure that includes: review of the previous session's material, new educational content, and discussion/application. Topics will include: 1) Overview, 2) Physical Activity (3 sessions), 3) Nutrition/Healthy Eating (3 sessions), 4) Managing Fatigue/Sleep (3 sessions), 5) Relaxation (3 sessions), 6) Tobacco cessation (3 sessions), 7) Substance Use (3 sessions), 8) Medication/Side Effects (3 sessions), 9) Review (1 session), and Closing (1session). Receives: Behavioral: Health & Wellness (H&W) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 12 Weeks
Differences in mean change on the CAINS MAP scale from baseline assessment to 12 week assessment. This scale contains a total of 9 items, each with a range of 0-4. Scores range from 0-36. Lower scores mean a better outcome.
Measured: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
Social Functioning Scale (SFS) - 12 Weeks
Differences in mean change on the SFS from baseline assessment to 12 week assessment. In the present analysis, we used a total score for the SFS including all subscales except the employment subscale. Scores ranged from 13-213. Higher scores mean a better outcome.
Measured: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 24 Weeks
Differences in mean change on the CAINS MAP scale from baseline assessment to 24 week assessment. This scale contains a total of 9 items, each with a range of 0-4. Scores range from 0-36. Lower scores mean a better outcome.
Measured: Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks
Social Functioning Scale (SFS) - 24 Weeks
Differences in mean change on the SFS from baseline assessment to 24 week assessment. In the present analysis, we used a total score for the SFS including all subscales except the employment subscale. Scores ranged from 13-213. Higher scores mean a better outcome.
Measured: Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks
Secondary outcomes (8)
University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 12 Weeks
Differences in mean change on the UPSA-B from baseline assessment to 12 week assessment. The UPSA-B has a range of 0-100 with higher scores mean a better outcome. In the present analysis, we used the square root of UPSA-B scores with range 0-10.
Measured: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
Maryland Assessment of Recovery Scale (MARS) - 12 Weeks
Differences in mean change on the MARS from baseline assessment to 12 week assessment. Scores can range from 25-125. Higher scores mean a better outcome.
Measured: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 12 Weeks
Differences in mean change on the CAINS SMAP from baseline assessment to 12 week assessment. This subscale has a total of 4 items each rated on a 0-4 score. The range of scores was 0-16. Lower scores mean a better outcome.
Measured: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
Role Functioning Scale (RFS) - 12 Weeks
Differences in mean change on the RFS from baseline assessment to 12 week assessment. Items are rated on a 1 to 7 scale. In the present analysis, we summed ratings of Family Network Relationships and Immediate Social Network Relationships as our measure of role functioning. Scores can range from 2-14. Higher scores mean a better outcome.
Measured: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 24 Weeks
Differences in mean change on the UPSA-B from baseline assessment to 24 week assessment. The UPSA-B has a range of 0-100 with higher scores mean a better outcome. In the present analysis, we used the square root of UPSA-B scores with range 0-10.
Measured: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
Maryland Assessment of Recovery Scale (MARS) - 24 Weeks
Differences in mean change on the MARS from baseline assessment to 24 week assessment. Scores can range from 25-125. Higher scores mean a better outcome.
Measured: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 24 Weeks
Differences in mean change on the CAINS SMAP from baseline assessment to 24 week assessment. This subscale has a total of 4 items each rated on a 0-4 score. The range of scores was 0-16. Lower scores mean a better outcome.
Measured: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
Role Functioning Scale (RFS) - 24 Weeks
Differences in mean change on the RFS from baseline assessment to 24 week assessment. Items are rated on a 1 to 7 scale. In the present analysis, we summed ratings of Family Network Relationships and Immediate Social Network Relationships as our measure of role functioning. Scores can range from 2-14. Higher scores mean a better outcome.
Measured: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study start3 Aug 2015
- Primary completion27 May 2020
- Study completion27 May 2020
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 (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Melanie E Bennett, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469389
- Sponsor's protocol ID
- D1293-R
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2015
- Last updated
- 13 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bennett ME, Kuykendall L, Harvey K, Lucksted A. Increasing community engagement: Skills used by adults with schizophrenia participating in a psychosocial intervention. Psychiatr Rehabil J. 2023 Mar;46(1):83-93. doi: 10.1037/prj0000549.
PubMed 36809019
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Negative Symptoms & Community Engagement in Veterans With Schizophrenia
- ClinicalTrials.gov ID
- NCT02469389
- Acronym / sponsor ID
- D1293-R
- Conditions
- Schizophrenia, Serious Mental Illness
- Keywords
- Schizophrenia, Negative Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Aug 2015 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 27 May 2020 (actual)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Posted 13 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to evaluate an innovative psychosocial intervention package that will incorporate evidence-based treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. The intervention - called EnCoRE (Engaging in Community Roles and Experiences) - will include strategies aimed at teaching Veterans with schizophrenia and negative symptoms ways to (1) overcome deficits in anticipatory pleasure, (2) increase intrinsic motivation for goal-directed activities, (3) reduce expectancies for failure, and (4) perform skillfully in new social situations, all of which can impact implementation of new skills and behaviors. Rather than develop a new set of intervention strategies, the investigators will include within EnCoRE evidence-based strategies for these treatment domains. In addition, the investigators will collect qualitative information both from Veterans concerning their perceptions of the strengths, weaknesses, and barriers to participation in EnCoRE, as well as from a sample of mental health providers who work with Veterans with schizophrenia and negative symptoms, in order to inform a larger scale implementation trial should EnCoRE prove effective here.
Detailed description
The goal of this study is to evaluate an innovative psychosocial intervention package that will incorporate evidence-based treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. The intervention - called EnCoRE (Engaging in Community Roles and Experiences) - will include strategies aimed at teaching Veterans with schizophrenia and negative symptoms ways to (1) overcome deficits in anticipatory pleasure, (2) increase intrinsic motivation for goal-directed activities, (3) reduce expectancies for failure, and (4) perform skillfully in new social situations, all of which can impact implementation of new skills and behaviors. Rather than develop a new set of intervention strategies, the investigators will include within EnCoRE evidence-based strategies for these treatment domains. In addition, the investigators will collect qualitative information both from Veterans concerning their perceptions of the strengths, weaknesses, and barriers to participation in EnCoRE, as well as from a sample of mental health providers who work with Veterans with schizophrenia and negative symptoms, in order to inform a larger scale implementation trial should EnCoRE prove effective here.
Following a short pilot to train interventionists and refine the manual, the investigators will conduct a randomized controlled trial to test the efficacy of EnCoRE in improving ratings of negative symptoms, functional outcomes, and engagement in community activities in a sample of Veterans with schizophrenia and negative symptoms (n=108). Participants will be randomized either to EnCoRE or a health-related control group. These goals fit well within the objectives of the Rehabilitation Research and Development (RR\&D) program of funding research aimed at studying rehabilitation interventions focused on maximizing functional recovery and assisting in the integration of Veterans into civilian life. Specifically, the investigators will address the following Specific Aims:
Specific Aim 1: Train therapists and refine the EnCoRE manual in a preliminary trial with 10 Veterans with schizophrenia and negative symptoms.
Specific Aim 2: Conduct a randomized controlled trial (n=108, medium effect, alpha=.05) to test the efficacy of EnCoRE in producing positive changes at post-treatment and 3-month follow-up on the primary outcomes of negative symptoms and social and community functioning.
Specific Aim 3: Examine qualitative interviews completed by (1) Veterans who participated in EnCoRE and (2) Mental Health Providers to determine aspects of EnCoRE that were perceived as more or less helpful, interesting, and valuable in order to make adjustments prior to conducting a larger, multi-site implementation trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Engaging in Community Roles and Experiences (ENCoRE) | Experimental | Behavioral: Engaging in Community Roles and Experiences (ENCoRE)Engaging in Community Roles and Experiences (ENCoRE) includes evidence-based psychosocial treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. Behavioral strategies include motivational enhancement, psychoeducation, cognitive therapy, and social skills training. |
| Health & Wellness (H&W) | Active comparator | Behavioral: Health & Wellness (H&W)Health \& Wellness (H\&W) will focus on health and wellness issues and education on ways to better manage health-related concerns following a basic structure that includes: review of the previous session's material, new educational content, and discussion/application. Topics will include: 1) Overview, 2) Physical Activity (3 sessions), 3) Nutrition/Healthy Eating (3 sessions), 4) Managing Fatigue/Sleep (3 sessions), 5) Relaxation (3 sessions), 6) Tobacco cessation (3 sessions), 7) Substance Use (3 sessions), 8) Medication/Side Effects (3 sessions), 9) Review (1 session), and Closing (1session). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnostic and Statistical Manual of Disorders, 5th edition (DSM 5) diagnosis of schizophrenia or schizoaffective disorder
- A minimum average rating of a "moderately severe deficit" (3 or greater on a 0-4 scale) on one symptom domain or a minimum average rating of a "moderate deficit" (2 or greater on a 0-4 scale) on two or more domains, within the affect motivation factor of the Clinical Assessment Interview for Negative Symptoms (CAINS) i.e.,:
- Age between 18 and 75 years
- Seen by a service provider twice within the last 6 months or once in the last 6 months consistently for two years, as in line with the Veteran's recorded mental health treatment plan (to demonstrate that participants receive ongoing and regular mental health care)
- Competent to sign Informed Consent
Key exclusion criteria (5 listed)
- Documented history of serious neurological disorder or head trauma with loss of consciousness
- Cognitive impairment (defined as a total intelligence quotient (IQ) score less than 70 as measured by the Wechsler Test of Adult Reading or as indicated by chart review
- Inability to effectively participate in the baseline assessments due to psychiatric symptoms on two successive appointments
- Current problematic substance use as indexed by scores on the Michigan Alcoholism Screening Test and the Drug Abuse Screening Test
- Currently meet criteria for a major depressive episode
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 |
|---|---|---|
| Engaging in Community Roles and Experiences (ENCoRE)Also: ENCoREEngaging in Community Roles and Experiences (ENCoRE) includes evidence-based psychosocial treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. Behavioral strategies include motivational enhancement, psychoeducation, cognitive therapy, and social skills training. | Behavioural | Engaging in Community Roles and Experiences (ENCoRE) |
| Health & Wellness (H&W)Also: H&WHealth \& Wellness (H\&W) will focus on health and wellness issues and education on ways to better manage health-related concerns following a basic structure that includes: review of the previous session's material, new educational content, and discussion/application. Topics will include: 1) Overview, 2) Physical Activity (3 sessions), 3) Nutrition/Healthy Eating (3 sessions), 4) Managing Fatigue/Sleep (3 sessions), 5) Relaxation (3 sessions), 6) Tobacco cessation (3 sessions), 7) Substance Use (3 sessions), 8) Medication/Side Effects (3 sessions), 9) Review (1 session), and Closing (1session). | Behavioural | Health & Wellness (H&W) |
Primary outcome
Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 12 Weeks
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
Differences in mean change on the CAINS MAP scale from baseline assessment to 12 week assessment. This scale contains a total of 9 items, each with a range of 0-4. Scores range from 0-36. Lower scores mean a better outcome.
Social Functioning Scale (SFS) - 12 Weeks
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
Differences in mean change on the SFS from baseline assessment to 12 week assessment. In the present analysis, we used a total score for the SFS including all subscales except the employment subscale. Scores ranged from 13-213. Higher scores mean a better outcome.
Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 24 Weeks
Time frame: Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks
Differences in mean change on the CAINS MAP scale from baseline assessment to 24 week assessment. This scale contains a total of 9 items, each with a range of 0-4. Scores range from 0-36. Lower scores mean a better outcome.
Social Functioning Scale (SFS) - 24 Weeks
Time frame: Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks
Differences in mean change on the SFS from baseline assessment to 24 week assessment. In the present analysis, we used a total score for the SFS including all subscales except the employment subscale. Scores ranged from 13-213. Higher scores mean a better outcome.
8 secondary outcomes
University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 12 Weeks
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
Maryland Assessment of Recovery Scale (MARS) - 12 Weeks
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 12 Weeks
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
Role Functioning Scale (RFS) - 12 Weeks
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 24 Weeks
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
Maryland Assessment of Recovery Scale (MARS) - 24 Weeks
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 24 Weeks
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
Role Functioning Scale (RFS) - 24 Weeks
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36809019Bennett ME, Kuykendall L, Harvey K, Lucksted A. Increasing community engagement: Skills used by adults with schizophrenia participating in a psychosocial intervention. Psychiatr Rehabil J. 2023 Mar;46(1):83-93. doi: 10.1037/prj0000549.
- 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.
Melanie E Bennett principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engaging in Community Roles and Experiences (ENCoRE) and Health & Wellness (H&W) in people with Schizophrenia and Serious Mental Illness, 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 8 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 13 Jul 2021. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2021). 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?
Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 12 Weeks (time frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks). 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?
On the ClinicalTrials.gov record for NCT02469389, which also lists 1 linked publication.
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 13 Jul 2021.