Adapting and Examining Collaborative Decision Skills Training Among Veterans With Serious Mental Illness

NCT04324944 | Completed

• 1 other identifier: D3079-W
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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 assigns equal participation and obligation to patients and providers across all aspects of decision-making, thereby empowering patients and facilitating better decision-making based on patient values and preferences. CDM is associated with several important outcomes including improved treatment engagement, treatment satisfaction, and social functioning. However, current levels of CDM among Veterans with SMI are low, and there is not yet an evidence-based method to improve CDM. Improving Veteran skill sets associated with engaging in CDM is a potential intervention strategy. Collaborative Decision Skills Training (CDST) is a promising new intervention that was previously developed by the applicant for use in adult civilians with SMI and found to improve relevant skills and improve sense of personal recovery. The proposed study has two primary stages. First, a small, one-armed, open label trial will establish CDST's feasibility will evaluate CDST among 12 Veterans with SMI receiving services at the VA San Diego Psychosocial Rehabilitation and Recovery Center (PRRC) and identify and complete any needed adaptations to CDST. Stakeholder feedback from Veterans, VA clinicians, and VA administrators will be collected to assess Veteran needs and service context to identify any needed adaptations to the CDST manual or the delivery of CDST to maximize its impact and feasibility. The developers of CDST will review all feedback and make final decisions about adaptations to ensure that CDST retains its essential components to protect against loss of efficacy. For example, a recommendation to adjust role-play topics to better reflect the needs of Veterans would be accepted because it would increase CDST's relevance without impairing its integrity, but a recommendation to remove all role-plays would not be accepted because it would cause loss of a key component. Second, CDST will be compared to active control (AC) using a randomized clinical trial of 72 Veterans. The primary outcome measure will be functioning within the rehabilitation context, operationalized as frequency of Veteran CDM behaviors during Veteran-provider interactions. Secondary outcomes are treatment attendance, engagement, satisfaction, and motivation, along with treatment outcomes (i.e., rehabilitation goal attainment, sense of personal recovery, symptom severity, and social functioning). Three exploratory outcomes will be assessed: Veteran-initiated collaborative behaviors, acute service use and provider attitudes and behavior. Veterans will be randomly assigned to CDST or AC conditions. Veterans in the both groups will attend eight hour-long group sessions held over eight weeks. All Veterans will complete an assessment battery at baseline, post-intervention, and at three-month post-intervention follow-up. Following the trial and adaptation phase, the findings will be used to develop a CDST service delivery manual and design a logical subsequent study. The results of the proposed study will inform the potential for larger trials of CDST and 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 data that will: 1) identify adaptations needed to optimize CDST for Veterans receiving services in PRRCs; 2) identify possible benefits of CDST; 3) inform development of alternate interventions or methods to improve CDM; and 4) further elucidate CDM and associated treatment processes among Veterans with SMI receiving VA rehabilitation services.

Conditions

Schizophrenia; Schizoaffective Disorder; Delusional Disorder; Major Depressive Disorder With Psychotic Features

Keywords

psychosis; serious mental illness; collaborative decision making; shared decision making; veterans; recovery; personal recovery

Outcome Measures

Primary Outcomes (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).

  Change in collaborative decision-making behaviors from baseline (month 0) to post-intervention (month 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).

  Change in collaborative decision-making behaviors from baseline (month 0) to follow-up at 3-months post-intervention (month 5)

Secondary Outcomes (35)

• Service Engagement Scale

  Change in service engagement from baseline (month 0) to post-intervention (month 2)

• Situational Motivation Scale for Schizophrenia Research

  Change in treatment motivation from baseline (month 0) to post-intervention (month 2)

• Interest in adjunctive rehabilitative approaches

  Change in interest in adjunctive rehabilitative approaches from baseline (month 0) to post-intervention (month 2)

• Client Satisfaction Questionnaire

  Change in client satisfaction from baseline (month 0) to post-intervention (month 2)

• Canadian Occupational Performance Measure- Performance subscale

  Change in goal attainment from baseline (month 0) to post-intervention (month 2)

Other Outcomes (5)

• Consumer-Created Opportunities for Active Involvement Coding System

  Change in consumer driven collaborative behaviors from baseline (month 0) to post-intervention (month 2)

• Acute service use

  Change in acute service use on a per month basis from 12 months prior to study start through 3 month post-intervention follow-up

• Adaptation and implementation focused qualitative interviews

  Post-intervention (month 2)

Study Arms (2)

Collaborative Decision Skills Training

EXPERIMENTAL

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

Behavioral: Collaborative Decision Skills Training

Leveling Up

ACTIVE COMPARATOR

Leveling Up is the active control arm.

Behavioral: Leveling Up

Interventions

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.

Collaborative Decision Skills Training

Leveling Up BEHAVIORAL

An ten-session group intervention that focuses on psychoeducation around befriending. Each session is 60 minutes long.

Leveling Up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• currently receive services in the VASDHS PRRC
• i.e., seen in the clinic in the past month and/or completed a PRRC group during the past trimester
• have an SMI diagnosis per the electronic medical record
• e.g., schizophrenia, schizoaffective disorder, delusional disorder, and major depressive disorder with psychotic features
• agree to have a subset of treatment appointments audiotaped

You may not qualify if:

• having primary substance use or organic neurological disorder diagnosis
• are determined by PRRC 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 PRRC and/or study staff determine to be too high risk to manage effectively at the PRRC's outpatient clinic location (which has less police presence than the primary VASDHS hospital location)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

Related Publications (2)

• Treichler EBH, McBride LE, Gomez E, Jain J, Seaton S, Yu KE, Oakes D, Perivoliotis D, Girard V, Reznik S, Salyers MP, Thomas ML, Spaulding WD, Granholm EL, Rabin BA, Light GA. Enhancing patient-clinician collaboration during treatment decision-making: study protocol for a community-engaged, mixed method hybrid type 1 trial of collaborative decision skills training (CDST) for veterans with psychosis. Trials. 2024 Jun 6;25(1):363. doi: 10.1186/s13063-024-08127-4.

  PMID: 38840160 DERIVED

• Treichler EBH, Rabin BA, Spaulding WD, Thomas ML, Salyers MP, Granholm EL, Cohen AN, Light GA. Skills-based intervention to enhance collaborative decision-making: systematic adaptation and open trial protocol for veterans with psychosis. Pilot Feasibility Stud. 2021 Mar 29;7(1):89. doi: 10.1186/s40814-021-00820-4.

  PMID: 33781352 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Schizophrenia, Paranoid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Emily Treichler, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research assistant 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The experimental design for this study is a 2-group randomized effectiveness trial, with assessments at baseline (month 0), post-intervention (month 2), and 3-month post-intervention follow-up (month 5). Veterans will be randomly assigned to either the CDST condition or to AC after completing baseline assessments. To maximize power for between-group comparisons, randomization will be 1:1 resulting in 36 participants per group. Participants will be randomly assigned by cohort, so that for each cohort, there are 12 participants each in CDST and AC. 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.

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 27, 2020
• Study Start: July 5, 2022
• Primary Completion: September 13, 2025
• Study Completion: September 13, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: IPD will be available six months after publication, and remain available for five years.
• Access Criteria: Data will be shared with researchers and consumer advocates who provide a rationale and methodological sound plan for their use of the data. Acceptable uses include meta-analysis and mega-analysis, among other uses. Data sets provided to requesters will include data necessary for the requester's stated purpose, as long as the requester's purpose does not violate participant privacy, research ethics, or similar procedures. Requests for access must be made in writing including an explicit assurance that the recipient will not attempt to identify or re-identify any individual. Requests must be signed by a requester currently residing in the United States. The request must reference the publication or other source motivating the request along with the detailed purpose for the request. Requests should be made to the corresponding author or the principal investigator, but can be made to the Associate Chief of Staff for Research.

Locations

US (1)