Implementation ScienceNCT07865078
Adapting and Implementing a Chronic Disease Self-Management Program for Primary Care Patients With Opioid Use Disorder and Serious Mental Illness
A study testing The Chronic Disease Self-Management Program (CDSMP) and Treatment as Usual plus self-management information in people with Implementation Science and Chronic Disease Self-management, run by University of Utah.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implementation Science, Chronic Disease Self-management, Mental Illness
- What is being tested?
- The Chronic Disease Self-Management Program (CDSMP) and Treatment as Usual plus self-management information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Cognitive impairment based on a score of 3 on the 6-item validated screener developed for clinical research
- Active suicidal ideation,
- Health complications that would preclude participation.
- Active psychosis or mania
- Plans to relocate during the study
- No locater information,
Show all 10Show fewer
- Pregnancy
- Current or upcoming incarceration
- Patient inclusion criteria Aim 2:
- Must have participated in Aim 1
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Implementation Science, Chronic Disease Self-management, Mental Illness, Addiction, Primary Care Patients With Chronic Conditions
- Being tested
- The Chronic Disease Self-Management Program (CDSMP), Treatment as Usual plus self-management information
- Keywords
- Chronic Disease Self-Management, Implementation Science, opioid use disorder
- Medical subject headings
- Mental Disorders, Behavior, Addictive, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Chronic Disease Self-Management Program (CDSMP)Other
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.
Treatment as Usual plus self-management informationOther
Participants assigned to this arm will receive treatment as usual plus self-management information
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual plus informational material | Active comparator | Individuals randomized to treatment as usual will receive medical care as usual plus informational material about chronic disease self-management Receives: Other: Treatment as Usual plus self-management information |
| The Chronic Disease Self-Management Program (CDSMP) | Experimental | 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. Receives: Other: The Chronic Disease Self-Management Program (CDSMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weekly during the 6-week intervention period
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Client satisfaction will be assessed at baseline, 3 weeks into intervention, end of intervention at 6 weeks, and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Implementation ScienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This pilot trial is studying the feasibility, acceptability, and initial impact of a CDSMP for primary care patients with OUD and SMI.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Elizabeth Siantz, University of Utah
- Investigators
- Elizabeth Siantz, PhD, MSW, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865078
- Sponsor's protocol ID
- K01DA059641
- Other IDs
- K01DA059641
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002 Nov 20;288(19):2469-75. doi: 10.1001/jama.288.19.2469.
PubMed 12435261Siantz E, Aranda MP. Chronic disease self-management interventions for adults with serious mental illness: a systematic review of the literature. Gen Hosp Psychiatry. 2014 May-Jun;36(3):233-44. doi: 10.1016/j.genhosppsych.2014.01.014. Epub 2014 Feb 10.
PubMed 24630896Lorig KR, Sobel DS, Stewart AL, Brown BW Jr, Bandura A, Ritter P, Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care. 1999 Jan;37(1):5-14. doi: 10.1097/00005650-199901000-00003.
PubMed 10413387Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.
PubMed 12867348
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Implementing a Chronic Disease Self-Management Program for Primary Care Patients With Opioid Use Disorder and Serious Mental Illness
- ClinicalTrials.gov ID
- NCT07865078
- Acronym / sponsor ID
- K01DA059641
- Conditions
- Implementation Science, Chronic Disease Self-management, Mental Illness, Addiction, Primary Care Patients With Chronic Conditions
- Keywords
- Chronic Disease Self-Management, Implementation Science, opioid use disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This pilot trial is studying the feasibility, acceptability, and initial impact of a CDSMP for primary care patients with OUD and SMI.
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual plus informational material | Active comparator | Other: Treatment as Usual plus self-management informationIndividuals randomized to treatment as usual will receive medical care as usual plus informational material about chronic disease self-management |
| The Chronic Disease Self-Management Program (CDSMP) | Experimental | Other: The Chronic Disease Self-Management Program (CDSMP)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Cognitive impairment based on a score of 3 on the 6-item validated screener developed for clinical research
- Active suicidal ideation,
- Health complications that would preclude participation.
- Active psychosis or mania
- Plans to relocate during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | The Chronic Disease Self-Management Program (CDSMP) |
| Treatment as Usual plus self-management informationParticipants assigned to this arm will receive treatment as usual plus self-management information | Other | Treatment as usual plus informational material |
Primary outcome
Intervention acceptability as measured by attendance
Time frame: Weekly during the 6-week intervention period
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.
4 secondary outcomes
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
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
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
Time frame: Client satisfaction will be assessed at baseline, 3 weeks into intervention, end of intervention at 6 weeks, and at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 12435261Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002 Nov 20;288(19):2469-75. doi: 10.1001/jama.288.19.2469.
- Background: PubMed 24630896Siantz E, Aranda MP. Chronic disease self-management interventions for adults with serious mental illness: a systematic review of the literature. Gen Hosp Psychiatry. 2014 May-Jun;36(3):233-44. doi: 10.1016/j.genhosppsych.2014.01.014. Epub 2014 Feb 10.
- Background: PubMed 10413387Lorig KR, Sobel DS, Stewart AL, Brown BW Jr, Bandura A, Ritter P, Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care. 1999 Jan;37(1):5-14. doi: 10.1097/00005650-199901000-00003.
- Background: PubMed 12867348Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Siantz, PhD, MSW principal investigator
University of Utah
Questions about this trial
What is this clinical trial studying?
A study testing The Chronic Disease Self-Management Program (CDSMP) and Treatment as Usual plus self-management information in people with Implementation Science and Chronic Disease Self-management, run by University of Utah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Siantz, PhD, MSW (801-585-0975, e.siantz@utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention acceptability as measured by attendance (time frame: Weekly during the 6-week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07865078, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.