Collaborative Decision Skills Training for Mental Illness
(CDST Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Substance use, Neurological disorder, Violence risk, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
12367How 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.
128910Eligibility 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
+2 more
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)
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Collaborative Decision Skills TrainingExperimental Treatment1 Intervention
Collaborative Decision Skills Training (CDST) is the intervention group (experimental arm).
Group II: Leveling UpActive Control1 Intervention
Leveling Up is the active control arm.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA San Diego Healthcare System, San Diego, CASan Diego, CA
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Skills-based intervention to enhance collaborative decision-making: systematic adaptation and open trial protocol for veterans with psychosis. [2021]Collaborative decision-making is an innovative decision-making approach that assigns equal power and responsibility to patients and providers. Most veterans with serious mental illnesses like schizophrenia want a greater role in treatment decisions, but there are no interventions targeted for this population. A skills-based intervention is promising because it is well-aligned with the recovery model, uses similar mechanisms as other evidence-based interventions in this population, and generalizes across decisional contexts while empowering veterans to decide when to initiate collaborative decision-making. Collaborative Decision Skills Training (CDST) was developed in a civilian serious mental illness sample and may fill this gap but needs to undergo a systematic adaptation process to ensure fit for veterans.
Collaborative decision skills training: Feasibility and preliminary outcomes of a novel intervention. [2020]Increasing consumer empowerment and agency in treatment decision-making is a priority for improving recovery among people with serious mental illness (SMI), as it is associated with a number of positive outcomes, including improved treatment engagement and satisfaction. Although there are many tools to promote initiation of shared decision-making by providers, there are few tools empowering consumers to independently initiate collaborative decision-making (CDM). Therefore, this study tests the feasibility of a novel skills training intervention for outpatients with SMI, collaborative decision skills training (CDST). Twenty-one consumers with SMI currently receiving community-based day services participated in CDST. Four areas of feasibility were assessed-acceptability, demand, practicality, and preliminary evidence of efficacy. Feasibility results were favorable, including high acceptability and practicality. Demand results were mixed: rates of attendance were high and attrition was low, but participants did not complete homework as often as expected. Finally, there was evidence CDST has a positive impact on targeted outcomes; participants reported an increased sense of personal recovery, and displayed improvements in both knowledge and skills targeted by CDST. CDST is feasible to implement with fidelity and is received well by participants. Next steps include larger controlled trials of CDST, which will better inform efficacy and implementation related questions. (PsycINFO Database Record (c) 2020 APA, all rights reserved).
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]Decision aids (DAs) are promising tools to foster evidence-based shared decision-making between practitioners and service users. Nevertheless, it is still obscure how an evidence-based DA for people with severe mental illness, especially psychosis, should look in an inpatient treatment setting to be useful and feasible. Therefore, we conducted focus groups with psychiatrists and service users to collect and assess their expectations and wishes regarding an evidence-based DA. From these findings, we derived immediate recommendations for the future development of DAs.
Effective Strategies for Nurses Empowering Clients With Schizophrenia: Medication Use as a Tool in Recovery. [2018]Clients with schizophrenia require maintenance treatment with antipsychotic medication and psychosocial therapy to maintain symptom control. Rates of medication adherence or follow-through are low in clients with schizophrenia. This increases the risk of relapse and contributes to poor quality of life. As educators and advisers, psychiatric nurses can collaborate with clients to improve adherence and other outcomes using shared decision-making techniques and tools that engage and empower clients to actively participate in decisions about their treatment. This article outlines effective strategies used by psychiatric nurses to improve outcomes in clients with schizophrenia and uses a case example for demonstrating this strategy in a client with schizophrenia.
How Shared Is Shared Decision Making? Reaching the Full Potential of Patient-Clinician Collaboration in Mental Health. [2022]Shared decision making in mental health is a priority for stakeholders, but faces significant implementation barriers, particularly in settings intended to serve people with serious mental illnesses (SMI). As a result, current levels of shared decision making are low. We highlight these barriers and propose that a novel paradigm, collaborative decision making, will offer conceptual and practical solutions at the systemic and patient/clinician level. Collaborative decision making is tailored for populations like people with SMI and other groups who experience chronic and complex symptoms, along with power imbalances within health systems. Advancing from shared decision making to collaborative decision making clarifies the mission of the model: to facilitate an empowering and recovery-oriented decision-making process that assigns equal power and responsibility to patients and clinicians; to improve alignment of treatment decisions with patient values and priorities; to increase patient trust and confidence in clinicians and the treatment process; and, in the end, to improve treatment engagement, satisfaction, and outcomes. The primary purpose of collaborative decision making is to increase values-aligned care, therefore prioritizing inclusion of patient values, including cultural values and quality of life-related outcomes. Given the broad and constantly changing context of treatment and care for many people with SMI (and also other groups), this model is dynamic and continuously evolving, ready for use across diverse contexts. Implementation of collaborative decision making includes increasing patient knowledge but also patient power, comfort, and confidence. It is one tool to reshape patient-clinician and patient-system relationships and to increase access to value-aligned care for people with SMI and other groups.
A web-based clinical decision tool to support treatment decision-making in psychiatry: a pilot focus group study with clinicians, patients and carers. [2022]Treatment decision tools have been developed in many fields of medicine, including psychiatry, however benefits for patients have not been sustained once the support is withdrawn. We have developed a web-based computerised clinical decision support tool (CDST), which can provide patients and clinicians with continuous, up-to-date, personalised information about the efficacy and tolerability of competing interventions. To test the feasibility and acceptability of the CDST we conducted a focus group study, aimed to explore the views of clinicians, patients and carers.
Shared decision-making in medication management: development of a training intervention. [2023]Shared decision-making is a collaborative process in which clinicians and patients make treatment decisions together. Although it is considered essential to patient-centred care, the adoption of shared decision-making into routine clinical practice has been slow, and there is a need to increase implementation. This paper describes the development and delivery of a training intervention to promote shared decision-making in medication management in mental health as part of the Shared Involvement in Medication Management Education (ShIMME) project. Three stakeholder groups (service users, care coordinators and psychiatrists) received training in shared decision-making, and their feedback was evaluated. The programme was mostly well received, with all groups rating interaction with peers as the best aspect of the training. This small-scale pilot shows that it is feasible to deliver training in shared decision-making to several key stakeholders. Larger studies will be required to assess the effectiveness of such training.
Development of a Shared Decision Making Model in a Community Mental Health Center. [2020]Shared Decision Making (SDM) is an essential component of recovery oriented treatment for clients with severe and persistent mental illnesses. SDM has been found to be effective in improving outcome of treatment of non-psychiatric ailments, and studies of SDM in community mental health settings are limited. We designed and implemented a low tech SDM program in a non-academic community mental health center and evaluated the outcome on decisional certainty and satisfaction with services. The results suggest that SDM can be effectively integrated with evidence based psychiatric rehabilitation practices utilizing already existing resources.
Supported Decision making teaching in New Zealand postgraduate psychiatry trainees. [2022]To examine psychiatric trainees teaching of supported decision-making (SDM).
A Systematic Review of Shared Decision-Making Interventions for Service Users With Serious Mental Illnesses: State of the Science and Future Directions. [2023]Shared decision making (SDM) is a health communication model that may be particularly appealing to service users with serious mental illnesses, who often want to be involved in making decisions about their mental health care. The purpose of this systematic review was to describe and evaluate participant, intervention, methodological, and outcome characteristics of SDM intervention studies conducted within this population.