Collaborative Decision Skills Training for Mental Illness

(CDST Trial)

Overseen By Emily B Treichler, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Substance use, Neurological disorder, Violence risk, others

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

Compensation: Varies

Number of Visits: 8

39 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the study staff or your healthcare provider.

What data supports the effectiveness of the treatment Collaborative Decision Skills Training for 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 (CDST) safe for humans?

The available research on Collaborative Decision Skills Training (CDST) suggests it is well-received and feasible to implement, with high acceptability and practicality among participants with serious mental illness. There are no specific safety concerns reported in the studies, indicating it is generally safe for humans. ^{1 2 3 6 7}

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

Collaborative Decision Skills Training (CDST) is unique because it empowers patients with serious mental illness to independently initiate collaborative decision-making with their healthcare providers, enhancing their sense of personal recovery and improving treatment engagement and satisfaction. Unlike other treatments, CDST focuses on teaching skills that allow patients to take an active role in their treatment decisions, aligning with the recovery model and addressing a gap in interventions for this population. ^{1 2 8 9 10}

What is the purpose of this trial?

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.

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 like schizophrenia and major depressive disorder, who are currently receiving services at the VA San Diego Psychosocial Rehabilitation and Recovery Center. Participants must be willing to have some treatment sessions recorded. Those with high violence risk or primary substance use disorders cannot join.

Inclusion Criteria

i.e., seen in the clinic in the past month and/or completed a PRRC group during the past trimester

You have certain mental health conditions such as schizophrenia or major depression with psychotic features.

currently receive services in the VASDHS PRRC

Exclusion Criteria

The study staff has determined that you may be at risk of worsening symptoms, having thoughts of suicide, or other risks by participating in the study.

I have been diagnosed with a substance use or brain disorder.

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Trial

A small, one-arm, open-label trial to establish feasibility of CDST and identify necessary adaptations

8 weeks

Weekly sessions

Randomized Controlled Trial (RCT)

Comparison of CDST with active control among 72 Veterans, focusing on collaborative decision-making behaviors

8 weeks

8 hour-long group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Post-intervention assessments

Treatment Details

Interventions

• Collaborative Decision Skills Training
• Money Management

Trial Overview The study tests Collaborative Decision Skills Training (CDST), aiming to empower Veterans by improving their decision-making skills in treatment settings. It involves an initial feasibility phase followed by a randomized trial comparing CDST against an active control through group sessions over eight weeks.

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

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]

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]

Clients with schizophrenia often struggle with low adherence to antipsychotic medication and psychosocial therapy, which can lead to relapse and a decreased quality of life.

Psychiatric nurses can enhance treatment outcomes by using shared decision-making techniques that empower clients to actively participate in their treatment decisions, as demonstrated through effective strategies and a case example.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective Strategies for Nurses Empowering Clients With Schizophrenia: Medication Use as a Tool in Recovery. Mahone, IH., Maphis, CF., Snow, DE.[2018]

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]

The web-based clinical decision support tool (CDST) was found to be useful in enhancing communication between patients, carers, and clinicians, promoting collaboration and personalized treatment options based on individual patient profiles.

Participants noted that while the CDST effectively facilitated discussions about medication side effects, the medical terminology used was too complex, which could raise ethical concerns regarding informed consent for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A web-based clinical decision tool to support treatment decision-making in psychiatry: a pilot focus group study with clinicians, patients and carers. Henshall, C., Marzano, L., Smith, K., 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]

A low-tech Shared Decision Making (SDM) program was successfully implemented in a community mental health center, showing that it can enhance treatment outcomes for clients with severe mental illnesses.

The integration of SDM with existing psychiatric rehabilitation practices improved clients' decisional certainty and satisfaction with services, indicating its effectiveness in mental health settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Shared Decision Making Model in a Community Mental Health Center. Paudel, S., Sharma, N., Joshi, A., et al.[2020]

A survey of 49 psychiatric trainees in New Zealand revealed that while there is some teaching on supported decision-making (SDM), the concept of experiential learning was the least endorsed, indicating a potential area for improvement in training.

The study identified three key factors in teaching SDM: 'enabling personhood', 'decision autonomy', and 'experiential learning', with gender being the only demographic factor that correlated with trainees' teaching experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supported Decision making teaching in New Zealand postgraduate psychiatry trainees. Newton-Howes, G., Daly, M., Cooney, J., et al.[2022]

Shared decision making (SDM) interventions for individuals with serious mental illnesses have been evaluated in 53 studies, primarily involving middle-aged, male, White participants from Western countries, indicating a need for more diverse research populations.

The review highlights the effectiveness of various SDM intervention types, suggesting future research should focus on expanding these interventions to include younger and racially diverse groups, as well as developing standardized measures to assess their impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Shared Decision-Making Interventions for Service Users With Serious Mental Illnesses: State of the Science and Future Directions. Thomas, EC., Ben-David, S., Treichler, E., et al.[2023]

References

1. 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]

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

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

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Effective Strategies for Nurses Empowering Clients With Schizophrenia: Medication Use as a Tool in Recovery. [2018]

5. 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]

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

A web-based clinical decision tool to support treatment decision-making in psychiatry: a pilot focus group study with clinicians, patients and carers. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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

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

Development of a Shared Decision Making Model in a Community Mental Health Center. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Supported Decision making teaching in New Zealand postgraduate psychiatry trainees. [2022]

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

A Systematic Review of Shared Decision-Making Interventions for Service Users With Serious Mental Illnesses: State of the Science and Future Directions. [2023]