NCT06898879

Brief 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 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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
40mo left

Started Jul 2026

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2028

1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

March 12, 2025

Last Update Submit

April 14, 2026

Conditions

Keywords

serious mental illnesspsychosiscollaborative decision-makingshared decision-makingveteransrecoverypersonal recoveryempowerment

Outcome Measures

Primary Outcomes (4)

  • 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).

    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).

    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.

    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.

    Baseline to 6-month follow-up

Secondary Outcomes (26)

  • Singh O'Brien Level of Engagement Scale

    Baseline to 3-month follow-up

  • Singh O'Brien Level of Engagement Scale

    Baseline to 6-month follow-up

  • Client Satisfaction Questionnaire

    Baseline to 3-month follow-up

  • Client Satisfaction Questionnaire

    Baseline to 6-month follow-up

  • Canadian Occupational Performance Measure- Performance subscale

    Baseline to 3-month follow-up

  • +21 more secondary outcomes

Other Outcomes (11)

  • Scale to Assess Therapeutic Relationship (patient and clinician versions)

    Baseline to 3-month follow-up

  • Scale to Assess Therapeutic Relationship (patient and clinician versions)

    Baseline to 6-month follow-up

  • Maslach Burnout Inventory

    Every three months for 2.5 year clinical trial duration

  • +8 more other outcomes

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

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.

Also known as: CDST
Collaborative Decision Skills Training
Leveling UpBEHAVIORAL

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

Also known as: LU
Leveling Up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003, United States

Location

New Mexico VA Health Care System, Albuquerque, NM

Albuquerque, New Mexico, 87108-5153, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersSchizophrenia, ParanoidBipolar DisorderDepressive Disorder, MajorEmpowerment

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersDepressive DisorderSocial BehaviorBehavior

Study Officials

  • Emily Treichler, PhD

    VA San Diego Healthcare System, San Diego, CA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Treichler, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 12, 2025

First Posted

March 27, 2025

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

April 3, 2028

Study Completion (Estimated)

September 30, 2029

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

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