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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach called Collaborative Decision Skills Training (CDST) to assist Veterans with serious mental illnesses, such as schizophrenia or major depressive disorder with psychotic features, in making treatment decisions with their healthcare providers. The goal is to enhance Veterans' engagement with their treatment, increase satisfaction, and support recovery. Participants are divided into two groups: one receives the CDST intervention, while the other receives an active control treatment focused on money management. Veterans participating should currently receive services at the VA San Diego Psychosocial Rehabilitation and Recovery Center and have an appropriate mental health diagnosis. As an unphased trial, this study offers Veterans the chance to contribute to innovative mental health treatment strategies.

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

Research has shown that Collaborative Decision Skills Training (CDST) can improve decision-making skills in individuals with serious mental illness. Although CDST is a newer method, studies in other groups suggest it enhances skills and personal recovery without causing harm. Specific data on safety or side effects for CDST is lacking, but as a training program rather than a medication, it generally poses fewer risks.

The trial is labeled "Not Applicable" in terms of phase, indicating it doesn't require the detailed safety testing that drug trials do. The focus is on training and empowerment, which are typically safe. For those considering joining the trial, it's important to know that CDST aims to help veterans take a more active role in their care, potentially leading to better satisfaction and social interactions. Based on current information, CDST appears to be a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Collaborative Decision Skills Training (CDST) because it empowers patients with mental illness to actively participate in their treatment decisions. Unlike traditional approaches that often focus on medication alone, CDST emphasizes building communication skills and collaborative decision-making between patients and healthcare providers. This approach aims to improve patient engagement and satisfaction, potentially leading to better adherence to treatment plans and improved mental health outcomes. By focusing on the decision-making process itself, CDST offers a novel way to complement existing therapies and address the complexities of mental health management.

What evidence suggests that Collaborative Decision Skills Training could be effective for Veterans with serious mental illness?

Research has shown that Collaborative Decision Skills Training (CDST), which participants in this trial may receive, can help individuals with serious mental illness (SMI) make decisions collaboratively. Studies have found that CDST leads to better involvement in treatment, greater satisfaction with care, and improved social interactions. Early findings suggest that CDST enhances collaboration between patients and healthcare providers, supporting personal recovery. Previous patients demonstrated improved participation in healthcare decisions. While CDST is still being tailored for Veterans, these early results are promising for increasing participation and improving outcomes in mental health care. ^{1 4 6 7 8}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

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]

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 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]

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]

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]

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]

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]

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 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]

Citations

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

Enhancing patient-clinician collaboration during treatment ... Within this aim, we hypothesize that CDST will demonstrate effectiveness via the primary outcome, collaborative decision-making behavior during ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30102050/

Collaborative decision skills training: Feasibility and ... This study tests the feasibility of a novel skills training intervention for outpatients with SMI, collaborative decision skills training (CDST).

3. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT04324944

Adapting and Examining Collaborative Decision Skills ... CDM is associated with several important outcomes including improved treatment engagement, treatment satisfaction, and social functioning.

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

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

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04324944?tab=history&a=2

Record History | ver. 2: 2020-04-28 | NCT04324944 This table shows all the versions of this study record arranged in order by submitted date. To view one version of the study record, click the submitted ...

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. researchgate.net researchgate.net/publication/315464862_SA134_Applying_Skills_Training_to_Improve_Shared_Decision-Making_in_Serious_Mental_Illness

SA134. Applying Skills Training to Improve Shared Decision- ... Applying Skills Training to Improve Shared Decision-Making in Serious Mental Illness ... outcome data suggest that CDST improves knowledge and skills ... safety ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04324944?tab=results

No Study Results Posted | Adapting and Examining ... Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.