Collaborative Decision Skills Training for Serious Mental Illness

(EVCC VPRRC Trial)

Recruiting at 2 trial locations

Overseen By Sirina Tiwari, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Substance use, Neurological disorder, Violence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 10 weeks

119 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on decision-making skills rather than medication changes.

What data supports the effectiveness of the treatment Collaborative Decision Skills Training, Leveling Up for serious mental illness?

Research shows that Collaborative Decision Skills Training (CDST) is promising for people with serious mental illness, as it increases personal recovery, knowledge, and skills, and is well-received by participants. It empowers patients to take an active role in their treatment decisions, which can lead to better treatment engagement and satisfaction. ^{1 2 3 4 5}

Is Collaborative Decision Skills Training safe for people with serious mental illness?

The available research on Collaborative Decision Skills Training (CDST) suggests it is safe for people with serious mental illness, as it was well-received by participants and showed high acceptability and practicality in studies. ^{1 2 3 5 6}

How is Collaborative Decision Skills Training different from other treatments for serious mental illness?

Collaborative Decision Skills Training is unique because it empowers patients with serious mental illness to take an active role in their treatment decisions, unlike other treatments that focus more on provider-led decision-making. This approach aligns with the recovery model and enhances personal recovery by improving patients' decision-making skills and engagement in their own care. ^{2 3 7 8 9}

Research Team

Emily Treichler, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Eligibility Criteria

This trial is for Veterans with serious mental illnesses such as schizophrenia, bipolar disorder, and major depression. Participants should be interested in improving collaboration with their clinicians to align care with personal goals. The study aims to empower Veterans and enhance their decision-making skills.

Inclusion Criteria

Be fluent and literate in English

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

Exclusion Criteria

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Veterans participate in 10 weekly group sessions of Collaborative Decision Skills Training (CDST) or active control

10 weeks

10 visits (in-person)

Follow-up

Participants are monitored for the durability of CDST's benefits and other outcomes

6 months

Assessments at post-intervention, 3-month, and 6-month follow-up

Treatment Details

Interventions

• Collaborative Decision Skills Training
• Leveling Up

Trial Overview The trial tests a group-based intervention called 'Leveling Up' alongside 'Collaborative Decision Skills Training'. It's designed to boost Veterans' ability to work together with healthcare providers, focusing on confidence, knowledge, and skill-building for better treatment outcomes.

Participant Groups

Group I: Collaborative Decision Skills Training Experimental Treatment 1 Intervention

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

Group II: Leveling Up Active Control 1 Intervention

Leveling Up is the active control arm.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Focus groups with 18 participants (8 service users and 10 psychiatrists) highlighted the need for a decision aid (DA) that is adaptable to different user needs and mental health conditions, emphasizing its potential usefulness in inpatient settings for selecting antipsychotics.

The digital format of the DA was particularly favored, with suggestions for it to include features like information dissemination through an app, indicating a strong interest in technology-enhanced tools for shared decision-making in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informing the development of a decision aid: Expectations and wishes from service users and psychiatrists towards a decision aid for antipsychotics in the inpatient setting. Müller, K., Schuster, F., Krumm, S., et al.[2023]

The study aims to adapt a Collaborative Decision Skills Training (CDST) intervention for veterans with serious mental illnesses, using qualitative interviews to ensure it meets their specific needs and the context of the VA system.

This will be the first evaluation of a collaborative decision-making intervention for veterans with serious mental illness, potentially enhancing their involvement in treatment decisions and contributing to a service delivery manual for future adaptations in VA settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skills-based intervention to enhance collaborative decision-making: systematic adaptation and open trial protocol for veterans with psychosis. Treichler, EBH., Rabin, BA., Spaulding, WD., et al.[2021]

A novel skills training intervention called collaborative decision skills training (CDST) was found to be feasible for outpatients with serious mental illness, with high acceptability and practicality among participants.

Participants in the CDST program reported increased personal recovery and improved knowledge and skills related to collaborative decision-making, suggesting positive preliminary evidence of its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative decision skills training: Feasibility and preliminary outcomes of a novel intervention. Treichler, EBH., Avila, A., Evans, EA., et al.[2020]

Current shared decision-making practices in mental health are low, especially for individuals with serious mental illnesses (SMI), due to significant implementation barriers.

The proposed collaborative decision-making model aims to empower patients and clinicians equally, enhancing treatment alignment with patient values and improving overall engagement, satisfaction, and outcomes in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Shared Is Shared Decision Making? Reaching the Full Potential of Patient-Clinician Collaboration in Mental Health. Treichler, EBH., Rabin, BA., Cohen, AN., et al.[2022]

A training intervention for shared decision-making in mental health medication management was developed and well-received by three groups: service users, care coordinators, and psychiatrists, highlighting the importance of collaboration in treatment decisions.

The pilot study indicates that it is feasible to implement training for shared decision-making, but further research with larger participant groups is needed to evaluate its effectiveness in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared decision-making in medication management: development of a training intervention. Stead, U., Morant, N., Ramon, S.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Informing the development of a decision aid: Expectations and wishes from service users and psychiatrists towards a decision aid for antipsychotics in the inpatient setting. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Skills-based intervention to enhance collaborative decision-making: systematic adaptation and open trial protocol for veterans with psychosis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Collaborative decision skills training: Feasibility and preliminary outcomes of a novel intervention. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

How Shared Is Shared Decision Making? Reaching the Full Potential of Patient-Clinician Collaboration in Mental Health. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Best practices: a program to support shared decision making in an outpatient psychiatric medication clinic. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Shared decision-making in medication management: development of a training intervention. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Predictors of shared decision making with people who have a serious mental illness and who are under justice supervision in the community. [2021]

8. Spain pubmed.ncbi.nlm.nih.gov

Assessment of shared decision-making in community mental health care: Validation of the CollaboRATE. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Implementing an intervention designed to enhance service user involvement in mental health care planning: a qualitative process evaluation. [2022]