An interventional study of The Chronic Disease Self-Management Program (CDSMP) and Treatment as Usual plus self-management information in Implementation Science, Chronic Disease Self-management and Mental Illness, sponsored by University of Utah. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by University of Utah · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate a self-management education program designed to help people with opioid use disorder (OUD), serious mental illness (SMI), and other chronic health conditions better manage their health. The program, called the Chronic Disease Self-Management Program (CDSMP), teaches self-management skills such as setting health goals, solving problems, managing symptoms, and working with health care providers. Participants will be randomly assigned to either participate in the CDSMP or receive usual primary care along with written information about managing their health. The study has two aims: Aim 1) The study will examine whether it is possible to deliver this program for primary care patients with OUD and SMI and whether patients find it helpful and acceptable. We will also look at early changes in participants' ability and confidence to manage their health conditions. Aim 2) The study will also examine how the program is delivered in each health care setting. Researchers will talk with patients and clinic staff and observe activities in the clinics to better understand what helps or makes it difficult to offer the program. This information will help researchers identify ways to improve the program and its delivery in primary care.
The purpose of this study is to evaluate the feasibility and initial impact of the Chronic Disease Self-Management Program (CDSMP) on the self-management of primary care patients with opioid use disorder (OUD), serious mental illness (SMI), and other chronic health conditions. The CDSMP is a peer-led, group-based program that teaches skills for managing chronic health conditions and for working effectively with health care providers. The program consists of six weekly 2.5 hour sessions focused on skills such as goal setting, action planning, problem solving, medication management, communication, and managing symptoms and difficult emotions. The CDSMP has an established evidence base, but has not been evaluated in a primary care setting for patients with opioid use disorder (OUD) and serious mental illness (SMI). This study will evaluate the feasibility, acceptability, and initial impact of a CDSMP designed to address the health and self-management needs of this population within primary care.
Aim 1: In this aim, we will evaluate the feasibility, acceptability, and initial impact of an adapted CDSMP for primary care patients with opioid use disorder and SMI. Participants will be randomly assigned to receive either the adapted CDSMP or usual primary care plus written information about health self-management. The study will be conducted at one VA primary care clinic and one University of Utah primary care clinic. Participants will complete assessments before, half way through, and after the program to evaluate patient participation, satisfaction, and changes in health self-management and related outcomes such as medication adherence and patient activation. A total of N = 20 patients will be recruited from each site; N = 10 will be randomized to the intervention condition and N = 10 will be randomized to treatment as usual plus self-management information.
Aim 2: In this aim, we will qualitatively study how the CDSMP is implemented in the two primary care settings using the Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) technique. Researchers will interview participants and clinic staff and observe clinic activities to understand experiences with the program, factors that make delivery easier or more difficult, and differences between the two study settings. This information will help identify ways to improve delivery of the program in primary care.
2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.
This study's planned enrollment of 40 is below the median of 94 across 1,574 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →University of Utah is the lead sponsor of 970 studies on the registry; 179 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
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Patient Inclusion Criteria Aim 1:
To participate in a post intervention qualitative interview, participants must have participated in the clinical trial, either in the intervention arm or the treatment as usual arm.
Exclusion Criteria Aim 1:
Patient inclusion criteria Aim 2:
- Must have participated in Aim 1
Individuals randomized to treatment as usual will receive medical care as usual plus informational material about chronic disease self-management
Other: Treatment as Usual plus self-management information
Participants randomized to the intervention group will participate in the CDSMP, which consists of six weekly 2.5-hour group sessions focused on developing skills for managing chronic health conditions, including goal setting, action planning, problem-solving, symptom management, physical activity, healthy eating, and managing difficult emotions.
Other: The Chronic Disease Self-Management Program (CDSMP)
Participants randomized to the intervention group will participate in the CDSMP program, which consists of six weekly 2.5 hour group sessions that provide education on self-management tasks across various conditions. The CDSMP is based on self-efficacy theory and incorporates skills mastery, reinterpretation of symptoms, modeling, and social persuasion to enhance a personal efficacy (i.e., confidence to manage aspects of one's health functioning). The CDSMP occurs in a group format, and sessions are led by two peer educators who have chronic medical conditions. CDSMP groups can include individuals with a range of chronic diseases. Example session topics include managing fatigue, the mind-body connection, action planning, problem-solving, dealing with difficult emotions, physical activity and exercise Making decisions, pain management, healthy eating.
Participants assigned to this arm will receive treatment as usual plus self-management information
Intervention acceptability as measured by attendance
Acceptability of the CDSMP intervention will be assessed by participant attendance at the six scheduled intervention sessions. Attendance will be calculated as the number and proportion of scheduled sessions attended by participants assigned to the CDSMP intervention.
Time frame: Weekly during the 6-week intervention period
Patient Activation
Patient activation will be evaluated using the Patient Activation Measure (PAM). PAM is a validated self-report measure of an individual's knowledge, skill, and confidence in managing their health and healthcare. It assesses patients' beliefs and behaviors related to taking an active role in managing their health, including engaging with healthcare providers, adhering to treatment plans, and maintaining healthy behaviors. The PAM is available in different versions, with the 13-item PAM commonly used in research and clinical settings. Higher scores indicate greater patient activation.
Time frame: Patient Activation will be assessed at baseline, 3 weeks into intervention, end of intervention at 6 weeks, and at 12 weeks
Medication adherence
Medication adherence will be evaluated using the Morisky Medication Adherence Scale (MMAS-4). The MMAS-4 is a 4-item self-report measure of medication-taking behavior. It assesses common reasons for nonadherence, including forgetting to take medications, carelessness, stopping medications when feeling better, and stopping medications when feeling worse. Scores range from 0 to 4, with higher scores indicating greater medication adherence.
Time frame: Medication adherence will be assessed at baseline, 3 weeks into intervention, end of intervention at 6 weeks, and at 12 weeks
Client Satisfaction
Client satisfaction will be measured using the Client Satisfaction Questionnaire (CSQ-8). CSQ-8 is an 8-item self-report measure of clients' satisfaction with health and human services. It assesses overall satisfaction with the service received, including perceived quality, usefulness, and whether the client's needs were met. Items are rated on a 4-point response scale, with total scores ranging from 8 to 32; higher scores indicate greater satisfaction.
Time frame: Client satisfaction will be assessed at baseline, 3 weeks into intervention, end of intervention at 6 weeks, and at 12 weeks
Health-related quality of life
Health-related quality of life will be measured using the SF-12. The SF-12 is a 12-item self-report measure of health-related quality of life. It assesses physical and mental health across domains including physical functioning, role limitations, pain, general health, vitality, social functioning, and emotional and mental health. Responses are summarized into Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, with higher scores generally indicating better health-related quality of life.
Time frame: Client satisfaction will be assessed at baseline, 3 weeks into intervention, end of intervention at 6 weeks, and at 12 weeks
No study locations are listed for this record.
Plan to share: Yes — Data to be shared: Individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, appendices) What documents will be available: study protocol, statistical analysis plan, analytic code. With whom the data will be shared: Researchers who provide a methodologically sound proposal. For what type of analysis: To achieve the aims in the approved proposal
Supporting information: Study protocol, Sap, Analytic code
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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