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Adapting and Examining Collaborative Decision Skills Training Among Veterans With Serious Mental Illness (CDST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04324944
Recruitment Status : Not yet recruiting
First Posted : March 27, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Delusional Disorder Major Depressive Disorder With Psychotic Features Behavioral: Collaborative Decision Skills Training Behavioral: Money Management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The experimental design for this study is a 2-group randomized effectiveness trial, with assessments at baseline (month 0), post-intervention (month 2), and 3-month post-intervention follow-up (month 5). Veterans will be randomly assigned to either the CDST condition or to AC after completing baseline assessments. To maximize power for between-group comparisons, randomization will be 1:1 resulting in 36 participants per group. Participants will be randomly assigned by cohort, so that for each cohort, there are 12 participants each in CDST and AC. Stratification may be introduced if necessary due to uneven or statistically different groups in key demographic domains (e.g., age, gender). Quantitative analyses will compare improvements in primary, secondary, and exploratory outcomes between the two groups, as described elsewhere. There are also qualitative outcomes associated with this study.
Masking: Single (Outcomes Assessor)
Masking Description: The research assistant who completes the assessments will be blind to condition, and will not attend any clinical team meetings or otherwise participate in any non-study related PRRC activities to maintain blindness. No study participants will be blinded. No other staff will be blinded.
Primary Purpose: Treatment
Official Title: Improving Collaborative Decision Making in Veterans With Serious Mental Illness
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : March 29, 2024
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
Experimental: Collaborative Decision Skills Training
Collaborative Decision Skills Training (CDST) is the intervention group (experimental arm).
Behavioral: Collaborative Decision Skills Training
An eight-session group-based skills training intervention that focuses on treatment-related decision-making in order to facilitate improved engagement in decision-making processes. CDST teaches assertiveness skills, problem solving, goal planning, and conflict negotiation, within the context of treatment planning and decision-making. Each session is 60 minutes long.

Active Comparator: Money Management
Money Management is the active control arm.
Behavioral: Money Management
An eight-session group intervention that focuses on psychoeducation around fundamental financial skills. Each session is 60 minutes long.




Primary Outcome Measures :
  1. Shared Decision-Making Coding System [ Time Frame: Change in collaborative decision-making behaviors from baseline (month 0) to post-intervention (month 2) ]
    The Shared Decision-Making Coding System (SDM-CS) is a validated method of coding collaborative behaviors during treatment decision-making among patients with SMI and their providers.The SDM-CDS codes 9 elements of the decision process including goal setting, exploration of patient preference, and treatment alternatives. Coding for this measure is completed by recording frequency of specific interactions (e.g., the patient states a preference). Scores range from 0-18, where higher scores are better (indicating more collaborative behaviors).

  2. Shared Decision-Making Coding System [ Time Frame: Change in collaborative decision-making behaviors from baseline (month 0) to follow-up at 3-months post-intervention (month 5) ]
    The Shared Decision-Making Coding System (SDM-CS) is a validated method of coding collaborative behaviors during treatment decision-making among patients with SMI and their providers.The SDM-CDS codes 9 elements of the decision process including goal setting, exploration of patient preference, and treatment alternatives. Coding for this measure is completed by recording frequency of specific interactions (e.g., the patient states a preference). Scores range from 0-18, where higher scores are better (indicating more collaborative behaviors).


Secondary Outcome Measures :
  1. Service Engagement Scale [ Time Frame: Change in service engagement from baseline (month 0) to post-intervention (month 2) ]
    A 14-item clinician-rated measure using a 4-point Likert scale. Scores range from 0-42, where higher scores indicate more service engagement.

  2. Situational Motivation Scale for Schizophrenia Research [ Time Frame: Change in treatment motivation from baseline (month 0) to post-intervention (month 2) ]
    16-item self-report measure, with scores ranging from 16-112, with higher scores indicating higher levels of motivation.

  3. Interest in adjunctive rehabilitative approaches [ Time Frame: Change in interest in adjunctive rehabilitative approaches from baseline (month 0) to post-intervention (month 2) ]
    Brief self-report survey assessing interest in rehabilitative approaches not previously engaged in. This scale will vary based on what rehabilitative approaches are currently being offered by the VASDHS PRRC and so the total score will also vary. Interest in each approach will be measured on a 0-4 Likert scale, and up to 10 approaches will be measured. Therefore the lowest possible score is 0 and highest possible score is 40. Higher scores will indicate more interest.

  4. Client Satisfaction Questionnaire [ Time Frame: Change in client satisfaction from baseline (month 0) to post-intervention (month 2) ]
    An 8-item self-report measure of client satisfaction, with scores ranging from 8-32. Higher scores indicate higher levels of satisfaction.

  5. Canadian Occupational Performance Measure- Performance subscale [ Time Frame: Change in goal attainment from baseline (month 0) to post-intervention (month 2) ]
    A short interview-based measure that assesses goal attainment in a range of functional areas. In this study, the investigators will use the performance subscale. The performance subscale is rated between 1-10, where higher scores indicate better performance.

  6. Goal Attainment Scaling [ Time Frame: Change in goal attainment from baseline (month 0) to post-intervention (month 2) ]
    An algorithm that identifies goals and goal attainment. Scores range from -2 to +2, with 0 meaning that the expected outcome was achieved, while lower scores mean that less favorable outcomes occurred, and higher scores mean that better than expected outcomes occurred.

  7. Maryland Assessment of Recovery in Serious Mental Illness [ Time Frame: Change in personal recovery from baseline (month 0) to post-intervention (month 2) ]
    A 25-item self-report measure that assesses personal alignment with six primary domains of recovery: self-direction or empowerment, holistic, nonlinear, strengths based, responsibility, and hope. Scores range from 25-125, with higher scores indicating higher levels of personal recovery.

  8. Brief Psychiatric Rating Scale [ Time Frame: Change in symptom severity from baseline (month 0) to post-intervention (month 2) ]
    A semi-structured interview that assesses 26 domains of symptoms. Scores range from 26-182, with higher scores indicating more severe symptoms.

  9. Social Skills Performance Assessment [ Time Frame: Change in social skills from baseline (month 0) to post-intervention (month 2) ]
    A measure of social functioning ability developed for adults with schizophrenia using role-plays of everyday social interactions. Scores range from 17 to 85, with higher scores indicating better social skill.

  10. Personal and Social Performance scale [ Time Frame: Change in social functioning from baseline (month 0) to post-intervention (month 2) ]
    A clinician-reported scale of patient ability in four areas: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Scores range from 1-100, with higher scores indicating better social functioning.

  11. Decision Skills Questionnaire [ Time Frame: Change in targeted skills from baseline (month 0) to post-intervention (month 2) ]
    A 10-item quiz of skills targeted by CDST. Scores range from 0-10, with higher scores indicating more correct answers.

  12. Collaborative Decision Making Approach Measure [ Time Frame: Change in involvement in treatment decisions from baseline (month 0) to post-intervention (month 2) ]
    3 item measure of involvement in treatment decisions. Scores range from 0-12, with higher scores indicating higher levels of involvement.

  13. Shared Decision Making Questionnaire for Mental Health [ Time Frame: Change in involvement in treatment decisions from baseline (month 0) to post-intervention (month 2) ]
    9 item measure of involvement in treatment decisions. Scores range from 0-45, with higher scores indicating high levels of involvement in treatment decisions.

  14. Problem-Solving Decision-Making Scale for Mental Health [ Time Frame: Change in preferences about involvement in treatment decisions from baseline (month 0) to post-intervention (month 2) ]
    Self-report about preferences for involvement in treatment decision-making based on three brief vignettes. There are 18 items and a total score range from 18-90, with lower scores indicating preference for paternalistic (provider-determined) decision-making, higher scores indicating preference for self-determination in treatment decisions, and middle scores indicating preference for provider-self collaboration.

  15. Decision Skills Checklist [ Time Frame: Change in targeted skills from baseline (month 0) to post-intervention (month 2) ]
    Clinician-rated 14-item checklist of targeted skills. Scores range from 0-28, with higher scores indicating better performance on targeted skills.

  16. Qualitative interviews [ Time Frame: Baseline (month 0) ]
    Veteran semi-structured interviews focused on constructs aligned with quantitative outcomes including involvement in decision-making, treatment engagement, motivation, and satisfaction, and attainment of recovery goals.

  17. Service Engagement Scale [ Time Frame: Change in service engagement from baseline (month 0) to follow-up at 3-months post-intervention (month 5) ]
    A 14-item clinician-rated measure using a 4-point Likert scale. Scores range from 0-42, where higher scores indicate more service engagement.

  18. Treatment attendance [ Time Frame: Change in treatment attendance from baseline (month 0) to post-intervention (month 2) ]
    Treatment attendance will be measured by attendance at all non-study-related PRRC appointments. These data will be collected from CPRS and confirmed with PRRC providers.

  19. Treatment attendance [ Time Frame: Change in treatment attendance from baseline (month 0) to follow-up at 3-months post-intervention (month 5) ]
    Treatment attendance will be measured by attendance at all non-study-related PRRC appointments. These data will be collected from CPRS and confirmed with PRRC providers.

  20. Situational Motivation Scale for Schizophrenia Research [ Time Frame: Change in treatment motivation from baseline (month 0) to follow-up at 3-months post-intervention (month 5) ]
    16-item self-report measure, with scores ranging from 16-112, with higher scores indicating higher levels of motivation.

  21. Interest in adjunctive rehabilitative approaches [ Time Frame: Change in interest in adjunctive rehabilitative approaches from baseline (month 0) to follow-up at 3-months post-intervention (month 5) ]
    Brief self-report survey assessing interest in rehabilitative approaches not previously engaged in. This scale will vary based on what rehabilitative approaches are currently being offered by the VASDHS PRRC and so the total score will also vary. Interest in each approach will be measured on a 0-4 Likert scale, and up to 10 approaches will be measured. Therefore the lowest possible score is 0 and highest possible score is 40.

  22. Client Satisfaction Questionnaire [ Time Frame: Change in client satisfaction from baseline (month 0) to follow-up at 3-months post-intervention (month 5) ]
    An 8-item self-report measure of client satisfaction, with scores ranging from 8-32. Higher scores indicate higher levels of satisfaction.

  23. Canadian Occupational Performance Measure- Performance subscale [ Time Frame: Change in goal attainment from baseline (month 0) to follow-up at 3-months post-intervention (month 5) ]
    A short interview-based measure that assesses goal attainment in a range of functional areas. In this study, the investigators will use the performance subscale. The performance subscale is rated between 1-10, where higher scores indicate better performance.

  24. Goal Attainment Scaling [ Time Frame: Change in goal attainment from baseline (month 0) to follow-up at 3-months post-intervention (month 5) ]
    An algorithm that identifies goals and goal attainment. Scores range from -2 to +2, with 0 meaning that the expected outcome was achieved, while lower scores mean that less favorable outcomes occurred, and higher scores mean that better than expected outcomes occurred.

  25. Maryland Assessment of Recovery in Serious Mental Illness [ Time Frame: Change in personal recovery from baseline (month 0) to follow-up at 3-months post-intervention (month 5) ]
    A 25-item self-report measure that assesses personal alignment with six primary domains of recovery: self-direction or empowerment, holistic, nonlinear, strengths based, responsibility, and hope. Scores range from 25-125, with higher scores indicating higher levels of personal recovery.

  26. Brief Psychiatric Rating Scale [ Time Frame: Change in symptom severity from baseline (month 0) to follow-up at 3-months post-intervention (month 5) ]
    A semi-structured interview that assesses 26 domains of symptoms. Scores range from 26-182, with higher scores indicating more severe symptoms.

  27. Social Skills Performance Assessment [ Time Frame: Change in symptom severity from baseline (month 0) to follow-up at 3-months post-intervention (month 5) ]
    A measure of social functioning ability developed for adults with schizophrenia using role-plays of everyday social interactions. Scores range from 17 to 85, with higher scores indicating better social skill.

  28. Personal and Social Performance scale [ Time Frame: Change in social functioning from baseline (month 0) to follow-up at 3-months post-intervention (month 5) ]
    A clinician-reported scale of patient ability in four areas: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Scores range from 1-100, with higher scores indicating better social functioning.

  29. Decision Skills Questionnaire [ Time Frame: Change in targeted skills from baseline (month 0) to follow-up at 3-months post-intervention (month 5) ]
    A 10-item quiz of skills targeted by CDST. Scores range from 0-10, with higher scores indicating more correct answers.

  30. Collaborative Decision Making Approach Measure [ Time Frame: Change in involvement in treatment decisions from baseline (month 0) to follow-up at 3-months post-intervention (month 5) ]
    3 item measure of involvement in treatment decisions. Scores range from 0-12, with higher scores indicating higher levels of involvement.

  31. Shared Decision Making Questionnaire for Mental Health [ Time Frame: Change in involvement in treatment decisions from baseline (month 0) to follow-up at 3-months post-intervention (month 5) ]
    9 item measure of involvement in treatment decisions. Scores range from 0-45, with higher scores indicating high levels of involvement in treatment decisions.

  32. Problem-Solving Decision-Making Scale for Mental Health [ Time Frame: Change in preferences about involvement in treatment decisions from baseline (month 0) to follow-up at 3-months post-intervention (month 5) ]
    Self-report about preferences for involvement in treatment decision-making based on three brief vignettes. There are 18 items and a total score range from 18-90, with lower scores indicating preference for paternalistic (provider-determined) decision-making, higher scores indicating preference for self-determination in treatment decisions, and middle scores indicating preference for provider-self collaboration.

  33. Decision Skills Checklist [ Time Frame: Change in targeted skills from from baseline (month 0) to follow-up at 3-months post-intervention (month 5). ]
    Clinician-rated 14-item checklist of targeted skills. Scores range from 0-28, with higher scores indicating better performance on targeted skills.

  34. Qualitative interviews [ Time Frame: Post-intervention (month 2) ]
    Veteran semi-structured interviews focused on constructs aligned with quantitative outcomes including involvement in decision-making, treatment engagement, motivation, and satisfaction, and attainment of recovery goals.

  35. Qualitative interviews [ Time Frame: follow-up at 3-months post-intervention (month 5) ]
    Veteran semi-structured interviews focused on constructs aligned with quantitative outcomes including involvement in decision-making, treatment engagement, motivation, and satisfaction, and attainment of recovery goals.


Other Outcome Measures:
  1. Consumer-Created Opportunities for Active Involvement Coding System [ Time Frame: Change in consumer driven collaborative behaviors from baseline (month 0) to post-intervention (month 2) ]
    A validated measure for adults with SMI that codes presence of consumer driven collaborative behaviors, including sharing opinions about treatment effectiveness, making requests, and reflecting on the therapeutic relationship. This measure codes behaviors, so the minimum score is 0, and it has no maximum. Higher scores indicate more collaborative behaviors initiated by the consumer.

  2. Acute service use [ Time Frame: Change in acute service use on a per month basis from 12 months prior to study start through 3 month post-intervention follow-up ]
    Review of electronic medical records to assess average acute service use per month.

  3. Adaptation and implementation focused qualitative interviews [ Time Frame: Post-intervention (month 2) ]
    Veterans and staff will complete semi-structured interviews focused on providing feedback on CDST to inform adaptations and implementation.

  4. CDST Participant Satisfaction Questionnaire [ Time Frame: post-intervention (month 2) ]
    Self-report questionnaire for the intervention studied. Score is a percentage, 0-100%, where higher scores indicate higher levels of satisfaction with the studied intervention.

  5. Consumer-Created Opportunities for Active Involvement Coding System [ Time Frame: Change in consumer driven collaborative behaviors from baseline (month 0) to follow-up at 3-months post-intervention (month 5) ]
    A validated measure for adults with SMI that codes presence of consumer driven collaborative behaviors, including sharing opinions about treatment effectiveness, making requests, and reflecting on the therapeutic relationship. This measure codes behaviors, so the minimum score is 0, and it has no maximum. Higher scores indicate more collaborative behaviors initiated by the consumer.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • currently receive services in the VASDHS PRRC

    • i.e., seen in the clinic in the past month and/or completed a PRRC group during the past trimester
  • have an SMI diagnosis per the electronic medical record

    • e.g., schizophrenia, schizoaffective disorder, delusional disorder, and major depressive disorder with psychotic features
  • agree to have a subset of treatment appointments audiotaped

Exclusion Criteria:

  • having primary substance use or organic neurological disorder diagnosis
  • are determined by PRRC 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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04324944


Contacts
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Contact: Emily Treichler, PhD Emily.Treichler@va.gov

Locations
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United States, California
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161
Contact: Emily Treichler, PhD       Emily.Treichler@va.gov   
Principal Investigator: Emily Treichler, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Emily Treichler, PhD VA San Diego Healthcare System, San Diego, CA
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04324944    
Other Study ID Numbers: D3079-W
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD underlying results in a publication will be shared. Deidentified data sets will be used for analysis and only these de-identified sets will be shared. All HIPAA identifiers, combinations of variables that might be used for re-identification, and proprietary information will be excluded. Audio data will not be shared; de-identified transcriptions and coding based on audio data will be. Only data needed to fulfill a requester's stated purpose will be shared. Therefore this plan will protect personal privacy of research subjects, prevent loss of confidentiality, and ensure the secure maintenance of propriety data and information.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: IPD will be available six months after publication, and remain available for five years.
Access Criteria:

Data will be shared with researchers and consumer advocates who provide a rationale and methodological sound plan for their use of the data. Acceptable uses include meta-analysis and mega-analysis, among other uses. Data sets provided to requesters will include data necessary for the requester's stated purpose, as long as the requester's purpose does not violate participant privacy, research ethics, or similar procedures.

Requests for access must be made in writing including an explicit assurance that the recipient will not attempt to identify or re-identify any individual. Requests must be signed by a requester currently residing in the United States. The request must reference the publication or other source motivating the request along with the detailed purpose for the request. Requests should be made to the corresponding author or the principal investigator, but can be made to the Associate Chief of Staff for Research.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
psychosis
serious mental illness
collaborative decision making
shared decision making
veterans
recovery
personal recovery
Additional relevant MeSH terms:
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Disease
Schizophrenia
Depressive Disorder
Depressive Disorder, Major
Psychotic Disorders
Mental Disorders
Schizophrenia, Paranoid
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mood Disorders