NCT Number: NCT06898879
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
VA San Diego Healthcare System, San Diego, CA, San Diego, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: CDST
An ten-session group intervention that focuses on psychoeducation, befriending, and Veteran to Veteran support. Each session is 60 minutes long.
Other names: LU
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).
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).
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.
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.
Time frame: Baseline to 3-month follow-up
A 14-item clinician-rated measure using a 4-point Likert scale. Scores range from 0-42, where higher scores indicate more service engagement.
Time frame: Baseline to 6-month follow-up
A 14-item clinician-rated measure using a 4-point Likert scale. Scores range from 0-42, where higher scores indicate more service engagement.
Time frame: Baseline to 3-month follow-up
An 8-item self-report measure of client satisfaction, with scores ranging from 8-32. Higher scores indicate higher levels of satisfaction.
Time frame: Baseline to 6-month follow-up
An 8-item self-report measure of client satisfaction, with scores ranging from 8-32. Higher scores indicate higher levels of satisfaction.
Time frame: Baseline to 3-month follow-up
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.
Time frame: Baseline to 6-month follow-up
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.
Time frame: Baseline to 3-month follow-up
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.
Time frame: Baseline to 6-month follow-up
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.
Time frame: Baseline to 3-month follow-up
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.
Time frame: Baseline to 6-month follow-up
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.
Time frame: Baseline to 3-month follow-up
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.
Time frame: Baseline to 6-month follow-up
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.
Time frame: Baseline to 3-month follow-up
9 item measure of involvement in treatment decisions. Scores range from 0-45, with higher scores indicating high levels of involvement in treatment decisions.
Time frame: Baseline to 6-month follow-up
9 item measure of involvement in treatment decisions. Scores range from 0-45, with higher scores indicating high levels of involvement in treatment decisions.
Time frame: Baseline to 3-month follow-up
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.
Time frame: Baseline to 6-month follow-up
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.
Time frame: Baseline to 3-month follow-up
13 item self report measure. Scores range 0-13, with higher scores indicating higher perceived involvement in care.
Time frame: Baseline to 6-month follow-up
13 item self report measure. Scores range 0-13, with higher scores indicating higher perceived involvement in care.
Time frame: Baseline to 3-month follow-up
28 item self-report measure. Scores range from 0-112, where lower scores indicate more empowerment. Developed specifically for people with serious mental illness.
Time frame: Baseline to 6-month follow-up
28 item self-report measure. Scores range from 0-112, where lower scores indicate more empowerment. Developed specifically for people with serious mental illness.
Time frame: Baseline to 3-month follow-up
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.
Time frame: Baseline to 6-month follow-up
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.
Time frame: Baseline to 3-month follow-up
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.
Time frame: Baseline to 6-month follow-up
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.
Time frame: Baseline to 3-month follow-up
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.
Time frame: Baseline to 6-month follow-up
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.
Time frame: Baseline to 3-month follow-up
12 item measure to assess therapeutic alliance. One is patient-completed and one is clinician-completed. Total scores range from 0-48, where higher scores indicate higher therapeutic alliance.
Time frame: Baseline to 6-month follow-up
12 item measure to assess therapeutic alliance. One is patient-completed and one is clinician-completed. Total scores range from 0-48, where higher scores indicate higher therapeutic alliance.
Time frame: Every three months for 2.5 year clinical trial duration
22 item measure of burnout. Includes three subscales, emotional exhaustion (9 items, total score ranging 0-54), depersonalization (5 items, total score ranging 0 - 30), and personal accomplishment (8 items, total score ranging from 0 -48). Total score therefore ranges from 0- 132. Higher scores indicate more burnout.
Time frame: Every three months for 2.5 year clinical trial duration
10 item self report measure. Scores range from 10-40 with higher scores indicate higher self efficacy.
Time frame: Every three months for 2.5 year clinical trial duration
20 item clinical report measure. Scores range from 20-100 where higher scores indicate greater knowledge of recovery and stronger recovery orientation.
Time frame: Every three months for 2.5 year clinical trial duration
six item self report scale of work climate related to two subconstructs (tasks and relationships with colleagues). Scoring ranges from 0-15 on each subscale and 0-30 overall, where higher scores indicate more positive climate.
Time frame: Every three months for 2.5 year clinical trial duration
8 item clinician report measure. Scores range from 0-40 where higher scores indicate greater use of collaborative decision-making and greater alignment with collaborative decision-making as a clinical practice.
Time frame: Every three months for 2.5 year clinical trial duration
Single 10-point item (Overall, how satisfied are you with your current job?")
Time frame: Baseline to 3-month follow-up
9 item patient completed scale. Total scores range from 9-63 where higher scores indicate better cultural competency experiences with clinicians.
Time frame: Baseline to 6-month follow-up
9 item patient completed scale. Total scores range from 9-63 where higher scores indicate better cultural competency experiences with clinicians.
Time frame: Baseline to six month follow up
Veteran semi-structured interviews focused on constructs aligned with quantitative outcomes including involvement in decision-making, treatment engagement, motivation, and satisfaction, and attainment of recovery goals. These interviews capture both primary, secondary, and pre-specified outcomes and will be triangulated with quantitative measures during the mixed methods integration process.
Contact information is provided by the study sponsor or research team.
VA Office of Research and Development
Fed
Enhancing Veteran-Clinical Collaboration in VA Psychosocial Rehabilitation and Recovery Centers
Acronym: EVCC VPRRC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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