Enhancing Veteran-Clinical Collaboration in VA PRRCs

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Collaborative Decision Skills Training

    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

    Behavioral

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

Treatment groups

119 Participants
are divided into 2 treatment groups
Group A: Collaborative Decision Skills TrainingExperimental treatment 1 intervention
Group B: Leveling UpActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline to 3-month follow-up
2

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).

Time frame
Baseline to 6-month follow-up
3

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.

Time frame
Baseline to 3-month follow-up
4

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.

Time frame
Baseline to 6-month follow-up

Secondary outcomes

1

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.

Time frame
Baseline to 3-month follow-up
2

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.

Time frame
Baseline to 6-month follow-up
3

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.

Time frame
Baseline to 3-month follow-up
4

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.

Time frame
Baseline to 6-month follow-up

Other outcomes

1

Scale to Assess Therapeutic Relationship (patient and clinician versions)

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 3-month follow-up
2

Scale to Assess Therapeutic Relationship (patient and clinician versions)

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
3

Maslach Burnout Inventory

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
4

General Self-Efficacy Scale

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

Sponsors and contacts

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