Collaborative Decision Skills Training for Serious Mental Illness

(EVCC VPRRC Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new group-based program to help Veterans with serious mental illness collaborate more effectively with their treatment teams. The goal is to empower Veterans by enhancing their comfort, confidence, and skills in making treatment decisions. The study will compare two groups: one will engage in the Collaborative Decision Skills Training, designed to improve decision-making abilities, while the other will participate in a program called Leveling Up. Veterans whose mental health disrupts daily life, such as work or school, and who receive mental health services at specific VA centers, might be a good fit. The findings could also benefit Veterans dealing with PTSD or chronic pain. As an unphased trial, this study offers Veterans a unique opportunity to contribute to innovative mental health solutions.

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 prior data suggests that this intervention is safe for Veterans with serious mental illness?

Research has shown that Collaborative Decision Skills Training (CDST) enhances collaboration between patients and doctors during treatment decisions. It emphasizes equal involvement and empowerment. The training aims to increase engagement and satisfaction with treatment.

Since CDST involves learning skills rather than taking medication or undergoing a medical procedure, it lacks the usual risks of physical side effects. No reports of negative effects from this training suggest that participants generally tolerate it well.

For those considering joining a trial with CDST, the main goal is to improve teamwork skills, which typically does not involve major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Collaborative Decision Skills Training (CDST) for serious mental illness because it emphasizes empowering patients through active engagement in their treatment plans. Unlike standard treatments, which often focus on medication and therapy prescribed by clinicians, CDST aims to enhance patients' decision-making skills, fostering a more collaborative approach to their care. This method could lead to improved treatment adherence and better outcomes by encouraging patients to take a more active role in managing their mental health. Additionally, the "Leveling Up" component serves as an active comparator, ensuring that the benefits of CDST are rigorously evaluated.

What evidence suggests that this trial's treatments could be effective for serious mental illness?

Research has shown that Collaborative Decision Skills Training (CDST), which participants in this trial may receive, helps patients with serious mental illness become more involved and satisfied with their treatment. Studies indicate that this training improves social skills by encouraging patients to take an active role in healthcare decisions. CDST aims to make individuals feel more at ease and confident when working with healthcare teams. These early findings suggest it can be a valuable tool for Veterans to better align their treatment with personal goals, potentially enhancing overall quality of life. ^{1 2 3 6 7}

Who Is on the Research Team?

Emily Treichler, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04324944

Adapting and Examining Collaborative Decision Skills ... Collaborative Decision Skills Training (CDST) is a promising new intervention that was previously developed by the applicant for use in adult civilians with SMI ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11155075/

Enhancing patient-clinician collaboration during treatment ... Collaborative decision skills training (CDST) is a novel intervention to increase CDM among veterans with SMI. CDST is an empowerment-oriented ...

3. withpower.com withpower.com/trial/collaborative-decision-skills-training-for-mental-illness-fce83

Collaborative Decision Skills Training for Mental Illness (CDST ... CDM is associated with several important outcomes including improved treatment engagement, treatment satisfaction, and social functioning. However, current ...

4. thecollablab.org thecollablab.org/research

Research | Collab Lab In this study, we aim to understand current and preferred treatment decision-making among Veterans with serious mental illness who identify as ethnic and/or ...

5. reporter.nih.gov reporter.nih.gov/project-details/11299459

RePORT RePORTER - National Institutes of Health (NIH) | Collaborative Decision Skills Training (CDST) is a promising new intervention that was previously developed by the applicant for use in adult civilians with SMI ...

6. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-021-00820-4

Skills-based intervention to enhance collaborative decision ... This study will be the first to evaluate a collaborative decision-making intervention among veterans with serious mental illness.

7. aaap.org aaap.org/smi-learning-collaborative-trainings/

SMI Learning Collaborative Trainings - AAAP Learn about the best evidence-based models of care to improve physical health outcomes in individuals who have serious mental illness (SMI).