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NCT04324944 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by VA Office of Research and Development.

Completed
Registry status
NA
Development phase
39
Enrollment target

NCT04324944: Completed NA study, sponsored by VA Office of Research and Development.

NCT04324944 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 39 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04324944, a NA study, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
NA
Development phase
39 participants
Enrollment target

Study 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 int

Primary Outcome

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 bet

Interventions

  • BEHAVIORAL Collaborative Decision Skills Training
  • BEHAVIORAL Leveling Up

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2022-07-05
Est. Completion 2025-09-13
Phase NA
VA Office of Research and Development

1,668 total trials

What the finished NCT04324944 record still lists

NCT04324944 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Collaborative Decision Skills Training is the first listed.

NCT04324944 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04324944 about?

NCT04324944 is a clinical study titled "Adapting and Examining Collaborative Decision Skills Training Among Veterans With Serious Mental Illness". 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 a...

What is the current status of trial NCT04324944?

This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2022-07-05. Estimated completion is 2025-09-13.

What interventions are being tested in trial NCT04324944?

The interventions under investigation include: Collaborative Decision Skills Training (BEHAVIORAL), Leveling Up (BEHAVIORAL).

Who is sponsoring clinical trial NCT04324944?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04324944's enrollment target sits among peer trials

39 1536th of 2000 higher than 463 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04324944, the US trial registry maintained by the National Library of Medicine. NCT04324944 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.