SchizophreniaEVCC VPRRCNCT06898879
Enhancing Veteran-Clinical Collaboration in VA PRRCs
A study testing Collaborative Decision Skills Training and Leveling Up in people with Schizophrenia and Schizoaffective Disorder, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
Over 60% of Veterans with serious mental illness have a service-connected disability that impairs their ability to work, go to school, and/or have successful personal lives. Although traditional treatments tend to focus on symptom remission, Veterans prioritize a range of treatment goals, including personal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Delusional Disorder
- What is being tested?
- Collaborative Decision Skills Training and Leveling Up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Aug 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Be a Veteran currently receiving Psychosocial Rehabilitation and Recovery Center (PRRC), Mental Health Intensive Case Management (MHICM) and/or Behavioral Health Interdisciplinary Program (BHIP) services at VA San Diego, Los Angeles, or Albuquerque (e.g., seen in the clinic in the past month or based on clinic criteria)
- Meet Substance Abuse and Mental Health Services Administration (SAMHSA) criteria of serious mental illness; i.e., "having (within the past year) a diagnosable mental, behavior, or emotional disorder that causes serious functional impairment that substantially interferes with or limits one or more major life activities," based on chart review and clinician consultation if needed
- Be fluent and literate in English
- Agree to have a subset of VA mental health treatment appointments audiotaped
Who cannot join
- Primary substance use or organic neurological disorder diagnosis determined by chart review
- Are determined by clinician and/or study staff to be at significant risk of exacerbation of symptoms, suicidal ideation, or other risk due to study participation
- Have a history and/or current risk of violence that clinicians and/or study staff determine to be too high risk to manage effectively in the study setting (e.g., poses a risk to Veterans or study staff)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, 87108-5153
Kate Belon, PhD, 505-265-1711 ext. 5943, Katherine.Belon@va.gov
- Not yet recruiting
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Emily Treichler, PhD, (858) 552-8585, Emily.Treichler@va.gov
Emily Treichler, PhD
- Not yet recruiting
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
Sonya Gabrielian, MD, 213-503-5519, Sonya.Gabrielian@va.gov
About this study
Official title: Enhancing Veteran-Clinical Collaboration in VA Psychosocial Rehabilitation and Recovery Centers
Over 60% of Veterans with serious mental illness have a service-connected disability that impairs their ability to work, go to school, and/or have successful personal lives. Although traditional treatments tend to focus on symptom remission, Veterans prioritize a range of treatment goals, including personal empowerment and gaining personally meaningful skills. Increasing Veteran-clinician collaboration can help effectively align care with each Veteran's goals and support an empowering therapeutic experience. This project will evaluate the effectiveness of a group-based intervention intended to increase Veterans' comfort, confidence, knowledge, and skills to collaborate with their treatment teams. Findings from this study will contribute important knowledge about this intervention's effectiveness and how to enhance its effectiveness, especially for Veterans from minoritized groups. If the decision-making intervention is effective, it would help Veterans with serious mental illness, and might also help Veterans with other chronic health conditions, like PTSD and chronic pain.
Read the detailed description
Recovery-oriented care is an imperative for the VA, particularly in mental health programming for Veterans with serious mental illness (SMI). Collaborative decision-making (CDM) is a recovery-oriented approach to treatment decision-making that supports meaningful involvement for patients across all aspects of decision- making, thereby empowering patients and facilitating better decision-making based on patient values, preferences, and cultural context. CDM is associated with several important outcomes including improved personal recovery, treatment engagement, treatment satisfaction, and social functioning. However, current levels of CDM among Veterans with SMI are low. Collaborative Decision Skills Training (CDST) is a promising 10-session group intervention that support Veterans to gain knowledge, skills, comfort, and confidence to collaborate with their clinicians and other members of their treatment teams. CDST has undergone initial testing in a VA Psychosocial Rehabilitation and Recovery Center (PRRC) and demonstrated feasibility for use among Veterans participating in PRRC care. This initial tests demonstrated preliminary evidence that CDST is effective at increasing Veteran-clinician collaboration, personal recovery, empowerment, treatment engagement, and social functioning.
Therefore, the proposed study will examine CDST's effectiveness among 119 Veterans with SMI participating in three PRRCs in the Southwestern United States (San Diego, Los Angeles, and Albuquerque). Veterans will be randomized to either CDST or active control (AC). The primary outcome measure will be functioning within the rehabilitation context, meaning Veteran CDM behavior during usual care VA mental health appointments. Secondary outcomes are treatment attendance, engagement, and satisfaction, along with functioning outside of the rehabilitation context (i.e., rehabilitation goal attainment, sense of personal recovery, empowerment symptom severity, and social functioning). Given that CDM is fundamentally an interaction between Veterans and their clinicians, the team will also assess whether clinician factors (i.e., engagement in CDST training or delivery; therapeutic alliance; work satisfaction; burnout; perceptions of self-efficacy; organizational climate; attitudes about recovery and CDM) moderate Veteran outcomes. Veterans in both groups will attend 10 hour- long group sessions held over 10 weeks.
All Veterans will complete an assessment battery at baseline, post-intervention, at three-month post- intervention follow-up, and at six-month follow-up. This will allow the team to assess durability of CDST's hypothesized benefits. Veterans who leave PRRC care and then return while the study is still active will complete one final assessment to further assess whether benefits are durable to re-entry to care. Additionally, the team will assess equity of benefits by assessing subgroup differences in benefits by race/ethnicity, gender, and sexual orientation. A team of Veterans and clinicians will be recruited to co-create consensus equity guidelines to support effective and equitable delivery of CDST in PRRCs.
The results of the proposed study will confirm CDST's benefits for Veterans in PRRC care and inform the utility of providing CDST broadly to Veterans with SMI. The results of this study will expand current understanding of CDM among Veterans with SMI by providing a large, diverse sample to 1) assess CDST's overall benefits; 2) durability and equity of those potential benefits; 3) whether and how clinician factors impact those potential benefits; and 4) identify how to deliver CDST and related interventions effectively and equitably.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Delusional Disorder, Bipolar Disorder, Major Depressive Disorder
- Being tested
- Collaborative Decision Skills Training, Leveling Up
- Keywords
- serious mental illness, psychosis, collaborative decision-making, shared decision-making, veterans, recovery, personal recovery, empowerment
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Schizophrenia, Paranoid, Bipolar Disorder, Depressive Disorder, Major, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Decision Skills TrainingBehavioural
Also called CDST
An ten-session group-based skills training intervention that focuses on treatment-related decision-making in order to facilitate improved engagement in decision-making processes. CDST teaches assertiveness skills, problem solving, goal planning, and conflict negotiation, within the context of treatment planning and decision-making. Each session is 60 minutes long.
Leveling UpBehavioural
Also called LU
An ten-session group intervention that focuses on psychoeducation, befriending, and Veteran to Veteran support. Each session is 60 minutes long.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Decision Skills Training | Experimental | Collaborative Decision Skills Training (CDST) is the intervention group (experimental arm). Receives: Behavioral: Collaborative Decision Skills Training |
| Leveling Up | Active comparator | Leveling Up is the active control arm. Receives: Behavioral: Leveling Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shared Decision-Making Coding System
The Shared Decision-Making Coding System (SDM-CS) is a validated method of coding collaborative behaviors during treatment decision-making among patients with SMI and their providers. The SDM-CDS codes 9 elements of the decision process including goal setting, exploration of patient preference, and treatment alternatives. Coding for this measure is completed by recording frequency of specific interactions (e.g., the patient states a preference). Scores range from 0-18, where higher scores are better (indicating more collaborative behaviors).
Measured: Baseline to 3-month follow-up
Shared Decision-Making Coding System
The Shared Decision-Making Coding System (SDM-CS) is a validated method of coding collaborative behaviors during treatment decision-making among patients with SMI and their providers. The SDM-CDS codes 9 elements of the decision process including goal setting, exploration of patient preference, and treatment alternatives. Coding for this measure is completed by recording frequency of specific interactions (e.g., the patient states a preference). Scores range from 0-18, where higher scores are better (indicating more collaborative behaviors).
Measured: Baseline to 6-month follow-up
Consumer-Created Opportunities for Active Involvement Coding System
A validated measure for adults with SMI that codes presence of consumer driven collaborative behaviors, including sharing opinions about treatment effectiveness, making requests, and reflecting on the therapeutic relationship. This measure codes behaviors, so the minimum score is 0, and it has no maximum. Higher scores indicate more collaborative behaviors initiated by the consumer.
Measured: Baseline to 3-month follow-up
Consumer-Created Opportunities for Active Involvement Coding System
A validated measure for adults with SMI that codes presence of consumer driven collaborative behaviors, including sharing opinions about treatment effectiveness, making requests, and reflecting on the therapeutic relationship. This measure codes behaviors, so the minimum score is 0, and it has no maximum. Higher scores indicate more collaborative behaviors initiated by the consumer.
Measured: Baseline to 6-month follow-up
Secondary outcomes (26)
Singh O'Brien Level of Engagement Scale
A 14-item clinician-rated measure using a 4-point Likert scale. Scores range from 0-42, where higher scores indicate more service engagement.
Measured: Baseline to 3-month follow-up
Singh O'Brien Level of Engagement Scale
A 14-item clinician-rated measure using a 4-point Likert scale. Scores range from 0-42, where higher scores indicate more service engagement.
Measured: Baseline to 6-month follow-up
Client Satisfaction Questionnaire
An 8-item self-report measure of client satisfaction, with scores ranging from 8-32. Higher scores indicate higher levels of satisfaction.
Measured: Baseline to 3-month follow-up
Client Satisfaction Questionnaire
An 8-item self-report measure of client satisfaction, with scores ranging from 8-32. Higher scores indicate higher levels of satisfaction.
Measured: Baseline to 6-month follow-up
Canadian Occupational Performance Measure- Performance subscale
A short interview-based measure that assesses goal attainment in a range of functional areas. In this study, the investigators will use the performance subscale. The performance subscale is rated between 1-10, where higher scores indicate better performance.
Measured: Baseline to 3-month follow-up
Canadian Occupational Performance Measure- Performance subscale
A short interview-based measure that assesses goal attainment in a range of functional areas. In this study, the investigators will use the performance subscale. The performance subscale is rated between 1-10, where higher scores indicate better performance.
Measured: Baseline to 6-month follow-up
Goal Attainment Scaling
An algorithm that identifies goals and goal attainment. Scores range from -2 to +2, with 0 meaning that the expected outcome was achieved, while lower scores mean that less favorable outcomes occurred, and higher scores mean that better than expected outcomes occurred.
Measured: Baseline to 3-month follow-up
Goal Attainment Scaling
An algorithm that identifies goals and goal attainment. Scores range from -2 to +2, with 0 meaning that the expected outcome was achieved, while lower scores mean that less favorable outcomes occurred, and higher scores mean that better than expected outcomes occurred.
Measured: Baseline to 6-month follow-up
Maryland Assessment of Recovery in Serious Mental Illness
A 25-item self-report measure that assesses personal alignment with six primary domains of recovery: self-direction or empowerment, holistic, nonlinear, strengths based, responsibility, and hope. Scores range from 25-125, with higher scores indicating higher levels of personal recovery.
Measured: Baseline to 3-month follow-up
Maryland Assessment of Recovery in Serious Mental Illness
A 25-item self-report measure that assesses personal alignment with six primary domains of recovery: self-direction or empowerment, holistic, nonlinear, strengths based, responsibility, and hope. Scores range from 25-125, with higher scores indicating higher levels of personal recovery.
Measured: Baseline to 6-month follow-up
Personal and Social Performance scale
A clinician-reported scale of patient ability in four areas: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Scores range from 1-100, with higher scores indicating better social functioning.
Measured: Baseline to 3-month follow-up
Personal and Social Performance scale
A clinician-reported scale of patient ability in four areas: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Scores range from 1-100, with higher scores indicating better social functioning.
Measured: Baseline to 6-month follow-up
Shared Decision Making Questionnaire for Mental Health
9 item measure of involvement in treatment decisions. Scores range from 0-45, with higher scores indicating high levels of involvement in treatment decisions.
Measured: Baseline to 3-month follow-up
Shared Decision Making Questionnaire for Mental Health
9 item measure of involvement in treatment decisions. Scores range from 0-45, with higher scores indicating high levels of involvement in treatment decisions.
Measured: Baseline to 6-month follow-up
Problem-Solving Decision-Making Scale for Mental Health
Self-report about preferences for involvement in treatment decision-making based on three brief vignettes. There are 18 items and a total score range from 18-90, with lower scores indicating preference for paternalistic (provider-determined) decision-making, higher scores indicating preference for self-determination in treatment decisions, and middle scores indicating preference for provider-self collaboration.
Measured: Baseline to 3-month follow-up
Problem-Solving Decision-Making Scale for Mental Health
Self-report about preferences for involvement in treatment decision-making based on three brief vignettes. There are 18 items and a total score range from 18-90, with lower scores indicating preference for paternalistic (provider-determined) decision-making, higher scores indicating preference for self-determination in treatment decisions, and middle scores indicating preference for provider-self collaboration.
Measured: Baseline to 6-month follow-up
Patient Perceived Involved in Care Scale
13 item self report measure. Scores range 0-13, with higher scores indicating higher perceived involvement in care.
Measured: Baseline to 3-month follow-up
Patient Perceived Involved in Care Scale
13 item self report measure. Scores range 0-13, with higher scores indicating higher perceived involvement in care.
Measured: Baseline to 6-month follow-up
Empowerment Scale
28 item self-report measure. Scores range from 0-112, where lower scores indicate more empowerment. Developed specifically for people with serious mental illness.
Measured: Baseline to 3-month follow-up
Empowerment Scale
28 item self-report measure. Scores range from 0-112, where lower scores indicate more empowerment. Developed specifically for people with serious mental illness.
Measured: Baseline to 6-month follow-up
Behaviour and Symptom Identification Scale (BASIS)
24 item self-report scale of broad mental health symptom severity, where higher scores indicate higher symptom severity. Total scores and subscales are based on weighted means of items, ranging of 0-4.
Measured: Baseline to 3-month follow-up
Behaviour and Symptom Identification Scale (BASIS)
24 item self-report scale of broad mental health symptom severity, where higher scores indicate higher symptom severity. Total scores and subscales are based on weighted means of items, ranging of 0-4.
Measured: Baseline to 6-month follow-up
Clinical Global Impression
Two item clinician rating of global illness severity. Higher scores indicate greater overall severity. Items are scored separately and both are on a 1-7 likert scale.
Measured: Baseline to 3-month follow-up
Clinical Global Impression
Two item clinician rating of global illness severity. Higher scores indicate greater overall severity. Items are scored separately and both are on a 1-7 likert scale.
Measured: Baseline to 6-month follow-up
Brief Inventory of Psychosocial Functioning
7 item self report measure of social functioning. Developed specifically for adults with serious mental illness. Total scores result in a 0-100 range where higher scores indicate higher functional impairment.
Measured: Baseline to 3-month follow-up
Brief Inventory of Psychosocial Functioning
7 item self report measure of social functioning. Developed specifically for adults with serious mental illness. Total scores result in a 0-100 range where higher scores indicate higher functional impairment.
Measured: Baseline to 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 Mar 2025
- Study start12 Aug 2026
- Primary completion3 Apr 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- The experimental design for this study is a 2-group randomized effectiveness trial, with assessments at baseline (month 0), post-intervention (month 3), and 3- and 6- post-intervention follow-ups (months 6 and 9). Veterans will be randomly assigned to either the CDST condition or to LU after completing baseline assessments. To maximize power for between-group comparisons, randomization will be 1:1 resulting in \~60 participants per group. Stratification may be introduced if necessary due to uneven or statistically different groups in key demographic domains (e.g., age, gender). Quantitative analyses will compare improvements in primary, secondary, and exploratory outcomes between the two groups, as described elsewhere. There are also qualitative outcomes associated with this study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Emily Treichler, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898879
- Sponsor's protocol ID
- D5052-R
- Other IDs
- RX005052
- Acronym
- EVCC VPRRC
- Status last verified
- Aug 2026
- First submitted
- 12 Mar 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD underlying results in a publication will be shared. Deidentified data sets will be used for analysis and only these de-identified sets will be shared. All HIPAA identifiers, combinations of variables that might be used for re-identification, and proprietary information will be excluded. Audio data will not be shared; de-identified transcriptions and coding based on audio data will be. Only data needed to fulfill a requester's stated purpose will be shared. Therefore this plan will protect personal privacy of research subjects, prevent loss of confidentiality, and ensure the secure maintenance of propriety data and information.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Veteran-Clinical Collaboration in VA Psychosocial Rehabilitation and Recovery Centers
- ClinicalTrials.gov ID
- NCT06898879
- Acronym / sponsor ID
- EVCC VPRRC / D5052-R
- Conditions
- Schizophrenia, Schizoaffective Disorder, Delusional Disorder, Bipolar Disorder, Major Depressive Disorder
- Keywords
- serious mental illness, psychosis, collaborative decision-making, shared decision-making, veterans, recovery, personal recovery, empowerment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- 3 Apr 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over 60% of Veterans with serious mental illness have a service-connected disability that impairs their ability to work, go to school, and/or have successful personal lives. Although traditional treatments tend to focus on symptom remission, Veterans prioritize a range of treatment goals, including personal empowerment and gaining personally meaningful skills. Increasing Veteran-clinician collaboration can help effectively align care with each Veteran's goals and support an empowering therapeutic experience. This project will evaluate the effectiveness of a group-based intervention intended to increase Veterans' comfort, confidence, knowledge, and skills to collaborate with their treatment teams. Findings from this study will contribute important knowledge about this intervention's effectiveness and how to enhance its effectiveness, especially for Veterans from minoritized groups. If the decision-making intervention is effective, it would help Veterans with serious mental illness, and might also help Veterans with other chronic health conditions, like PTSD and chronic pain.
Detailed description
Recovery-oriented care is an imperative for the VA, particularly in mental health programming for Veterans with serious mental illness (SMI). Collaborative decision-making (CDM) is a recovery-oriented approach to treatment decision-making that supports meaningful involvement for patients across all aspects of decision- making, thereby empowering patients and facilitating better decision-making based on patient values, preferences, and cultural context. CDM is associated with several important outcomes including improved personal recovery, treatment engagement, treatment satisfaction, and social functioning. However, current levels of CDM among Veterans with SMI are low. Collaborative Decision Skills Training (CDST) is a promising 10-session group intervention that support Veterans to gain knowledge, skills, comfort, and confidence to collaborate with their clinicians and other members of their treatment teams. CDST has undergone initial testing in a VA Psychosocial Rehabilitation and Recovery Center (PRRC) and demonstrated feasibility for use among Veterans participating in PRRC care. This initial tests demonstrated preliminary evidence that CDST is effective at increasing Veteran-clinician collaboration, personal recovery, empowerment, treatment engagement, and social functioning.
Therefore, the proposed study will examine CDST's effectiveness among 119 Veterans with SMI participating in three PRRCs in the Southwestern United States (San Diego, Los Angeles, and Albuquerque). Veterans will be randomized to either CDST or active control (AC). The primary outcome measure will be functioning within the rehabilitation context, meaning Veteran CDM behavior during usual care VA mental health appointments. Secondary outcomes are treatment attendance, engagement, and satisfaction, along with functioning outside of the rehabilitation context (i.e., rehabilitation goal attainment, sense of personal recovery, empowerment symptom severity, and social functioning). Given that CDM is fundamentally an interaction between Veterans and their clinicians, the team will also assess whether clinician factors (i.e., engagement in CDST training or delivery; therapeutic alliance; work satisfaction; burnout; perceptions of self-efficacy; organizational climate; attitudes about recovery and CDM) moderate Veteran outcomes. Veterans in both groups will attend 10 hour- long group sessions held over 10 weeks.
All Veterans will complete an assessment battery at baseline, post-intervention, at three-month post- intervention follow-up, and at six-month follow-up. This will allow the team to assess durability of CDST's hypothesized benefits. Veterans who leave PRRC care and then return while the study is still active will complete one final assessment to further assess whether benefits are durable to re-entry to care. Additionally, the team will assess equity of benefits by assessing subgroup differences in benefits by race/ethnicity, gender, and sexual orientation. A team of Veterans and clinicians will be recruited to co-create consensus equity guidelines to support effective and equitable delivery of CDST in PRRCs.
The results of the proposed study will confirm CDST's benefits for Veterans in PRRC care and inform the utility of providing CDST broadly to Veterans with SMI. The results of this study will expand current understanding of CDM among Veterans with SMI by providing a large, diverse sample to 1) assess CDST's overall benefits; 2) durability and equity of those potential benefits; 3) whether and how clinician factors impact those potential benefits; and 4) identify how to deliver CDST and related interventions effectively and equitably.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The experimental design for this study is a 2-group randomized effectiveness trial, with assessments at baseline (month 0), post-intervention (month 3), and 3- and 6- post-intervention follow-ups (months 6 and 9). Veterans will be randomly assigned to either the CDST condition or to LU after completing baseline assessments. To maximize power for between-group comparisons, randomization will be 1:1 resulting in ~60 participants per group. Stratification may be introduced if necessary due to uneven or statistically different groups in key demographic domains (e.g., age, gender). Quantitative analyses will compare improvements in primary, secondary, and exploratory outcomes between the two groups, as described elsewhere. There are also qualitative outcomes associated with this study.
| Arm | Type | Receives |
|---|---|---|
| Collaborative Decision Skills Training | Experimental | Behavioral: Collaborative Decision Skills TrainingCollaborative Decision Skills Training (CDST) is the intervention group (experimental arm). |
| Leveling Up | Active comparator | Behavioral: Leveling UpLeveling Up is the active control arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be a Veteran currently receiving Psychosocial Rehabilitation and Recovery Center (PRRC), Mental Health Intensive Case Management (MHICM) and/or Behavioral Health Interdisciplinary Program (BHIP) services at VA San Diego, Los Angeles, or Albuquerque (e.g., seen in the clinic in the past month or based on clinic criteria)
- Meet Substance Abuse and Mental Health Services Administration (SAMHSA) criteria of serious mental illness; i.e., "having (within the past year) a diagnosable mental, behavior, or emotional disorder that causes serious functional impairment that substantially interferes with or limits one or more major life activities," based on chart review and clinician consultation if needed
- Be fluent and literate in English
- Agree to have a subset of VA mental health treatment appointments audiotaped
Key exclusion criteria (3 listed)
- Primary substance use or organic neurological disorder diagnosis determined by chart review
- Are determined by clinician and/or study staff to be at significant risk of exacerbation of symptoms, suicidal ideation, or other risk due to study participation
- Have a history and/or current risk of violence that clinicians and/or study staff determine to be too high risk to manage effectively in the study setting (e.g., poses a risk to Veterans or study staff)
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 |
|---|---|---|
| Collaborative Decision Skills TrainingAlso: CDSTAn ten-session group-based skills training intervention that focuses on treatment-related decision-making in order to facilitate improved engagement in decision-making processes. CDST teaches assertiveness skills, problem solving, goal planning, and conflict negotiation, within the context of treatment planning and decision-making. Each session is 60 minutes long. | Behavioural | Collaborative Decision Skills Training |
| Leveling UpAlso: LUAn ten-session group intervention that focuses on psychoeducation, befriending, and Veteran to Veteran support. Each session is 60 minutes long. | Behavioural | Leveling Up |
Primary outcome
Shared Decision-Making Coding System
Time frame: Baseline to 3-month follow-up
The Shared Decision-Making Coding System (SDM-CS) is a validated method of coding collaborative behaviors during treatment decision-making among patients with SMI and their providers. The SDM-CDS codes 9 elements of the decision process including goal setting, exploration of patient preference, and treatment alternatives. Coding for this measure is completed by recording frequency of specific interactions (e.g., the patient states a preference). Scores range from 0-18, where higher scores are better (indicating more collaborative behaviors).
Shared Decision-Making Coding System
Time frame: Baseline to 6-month follow-up
The Shared Decision-Making Coding System (SDM-CS) is a validated method of coding collaborative behaviors during treatment decision-making among patients with SMI and their providers. The SDM-CDS codes 9 elements of the decision process including goal setting, exploration of patient preference, and treatment alternatives. Coding for this measure is completed by recording frequency of specific interactions (e.g., the patient states a preference). Scores range from 0-18, where higher scores are better (indicating more collaborative behaviors).
Consumer-Created Opportunities for Active Involvement Coding System
Time frame: Baseline to 3-month follow-up
A validated measure for adults with SMI that codes presence of consumer driven collaborative behaviors, including sharing opinions about treatment effectiveness, making requests, and reflecting on the therapeutic relationship. This measure codes behaviors, so the minimum score is 0, and it has no maximum. Higher scores indicate more collaborative behaviors initiated by the consumer.
Consumer-Created Opportunities for Active Involvement Coding System
Time frame: Baseline to 6-month follow-up
A validated measure for adults with SMI that codes presence of consumer driven collaborative behaviors, including sharing opinions about treatment effectiveness, making requests, and reflecting on the therapeutic relationship. This measure codes behaviors, so the minimum score is 0, and it has no maximum. Higher scores indicate more collaborative behaviors initiated by the consumer.
26 secondary outcomes
Singh O'Brien Level of Engagement Scale
Time frame: Baseline to 3-month follow-up
Singh O'Brien Level of Engagement Scale
Time frame: Baseline to 6-month follow-up
Client Satisfaction Questionnaire
Time frame: Baseline to 3-month follow-up
Client Satisfaction Questionnaire
Time frame: Baseline to 6-month follow-up
Canadian Occupational Performance Measure- Performance subscale
Time frame: Baseline to 3-month follow-up
Canadian Occupational Performance Measure- Performance subscale
Time frame: Baseline to 6-month follow-up
Goal Attainment Scaling
Time frame: Baseline to 3-month follow-up
Goal Attainment Scaling
Time frame: Baseline to 6-month follow-up
Maryland Assessment of Recovery in Serious Mental Illness
Time frame: Baseline to 3-month follow-up
Maryland Assessment of Recovery in Serious Mental Illness
Time frame: Baseline to 6-month follow-up
Personal and Social Performance scale
Time frame: Baseline to 3-month follow-up
Personal and Social Performance scale
Time frame: Baseline to 6-month follow-up
Shared Decision Making Questionnaire for Mental Health
Time frame: Baseline to 3-month follow-up
Shared Decision Making Questionnaire for Mental Health
Time frame: Baseline to 6-month follow-up
Problem-Solving Decision-Making Scale for Mental Health
Time frame: Baseline to 3-month follow-up
Problem-Solving Decision-Making Scale for Mental Health
Time frame: Baseline to 6-month follow-up
Patient Perceived Involved in Care Scale
Time frame: Baseline to 3-month follow-up
Patient Perceived Involved in Care Scale
Time frame: Baseline to 6-month follow-up
Empowerment Scale
Time frame: Baseline to 3-month follow-up
Empowerment Scale
Time frame: Baseline to 6-month follow-up
Behaviour and Symptom Identification Scale (BASIS)
Time frame: Baseline to 3-month follow-up
Behaviour and Symptom Identification Scale (BASIS)
Time frame: Baseline to 6-month follow-up
Clinical Global Impression
Time frame: Baseline to 3-month follow-up
Clinical Global Impression
Time frame: Baseline to 6-month follow-up
Brief Inventory of Psychosocial Functioning
Time frame: Baseline to 3-month follow-up
Brief Inventory of Psychosocial Functioning
Time frame: Baseline to 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. IPD underlying results in a publication will be shared. Deidentified data sets will be used for analysis and only these de-identified sets will be shared. All HIPAA identifiers, combinations of variables that might be used for re-identification, and proprietary information will be excluded. Audio data will not be shared; de-identified transcriptions and coding based on audio data will be. Only data needed to fulfill a requester's stated purpose will be shared. Therefore this plan will protect personal privacy of research subjects, prevent loss of confidentiality, and ensure the secure maintenance of propriety data and information.
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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.
Emily Treichler, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Decision Skills Training and Leveling Up in people with Schizophrenia and Schizoaffective Disorder, run by VA Office of Research and Development at 3 sites 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Treichler, PhD ((858) 552-8585, Emily.Treichler@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shared Decision-Making Coding System (time frame: Baseline to 3-month follow-up). 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 19 Aug 2026.