Enhancing Veteran-Clinical Collaboration in VA PRRCs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2029-09-30

Brief Summary

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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.

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Detailed Description

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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

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Schizophrenia Schizoaffective Disorder Delusional Disorder Bipolar Disorder Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The research assistants who completes the assessments will be blind to condition, and will not attend any clinical team meetings or otherwise participate in any non-study related PRRC activities to maintain blindness. No study participants will be blinded. No other staff will be blinded.

Study Groups

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Collaborative Decision Skills Training

Collaborative Decision Skills Training (CDST) is the intervention group (experimental arm).

Group Type EXPERIMENTAL

Collaborative Decision Skills Training

Intervention Type BEHAVIORAL

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 Up

Leveling Up is the active control arm.

Group Type ACTIVE_COMPARATOR

Leveling Up

Intervention Type BEHAVIORAL

An ten-session group intervention that focuses on psychoeducation, befriending, and Veteran to Veteran support. Each session is 60 minutes long.

Interventions

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Collaborative Decision Skills Training

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.

Intervention Type BEHAVIORAL

Leveling Up

An ten-session group intervention that focuses on psychoeducation, befriending, and Veteran to Veteran support. Each session is 60 minutes long.

Intervention Type BEHAVIORAL

Other Intervention Names

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CDST LU

Eligibility Criteria

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Inclusion Criteria

* be a Veteran currently receiving PRRC, MHICM and/or 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 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 age 18 or above
* Be fluent and literate in English.
* Agree to have a subset of VA mental health treatment appointments audiotaped

Exclusion Criteria

* 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No