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CBT + Self-Management Program for Chronic Pain

N/A
Waitlist Available
Led By Beth Darnall, Ph.D.
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months
Awards & highlights

Study Summary

This trial will help inform patients and physicians about the most effective route to pain control, reduced pain interference, and improved role function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Opioid use
Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pain Intensity

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Chronic Pain Self Management ProgramActive Control1 Intervention
The CPSMP is similar to pain-CBT in format and content but is peer-led, and is effective across pain conditions (e.g., back pain, arthritis) for improving pain and pain self-efficacy. The CPSMP consists of six weekly 2-hour group sessions in which two peer co-leaders provide patient education about pain, effective self-management, pain impacts, and other symptoms from a highly structured manual. Peers are people with chronic pain who live in the communities in which they teach. For this project, at least one peer facilitator per workshop will have had experience with prescription opioid use. Intervention fidelity is determined by having a trained observer with a checklist attend random workshop sessions. Similar to pain-CBT, CPSMP incorporates interactive discussion, practice of relaxation training, action planning, and home exercises into each session.
Group II: Observational ArmActive Control1 Intervention
Participants that do not wish to reduce their opioid medications but are otherwise eligible and interested in the research study will be offered participation in the observational arm. The observational arm of the study will not include interventions of any kind and will only collect survey data for the year following consent.
Group III: Cognitive Behavioral TherapyActive Control1 Intervention
A trained psychologist delivers pain-CBT to individual patients or groups of patients with chronic pain. Group treatment is delivered across 8 weekly sessions that last for 2 hours each. Pain-CBT incorporates interactive discussion, practice of relaxation training, action planning, and home exercises into each session. Pain-CBT is effective for reducing pain intensity, pain catastrophizing, depression and social impacts.
Group IV: Taper Only (Usual Care)Placebo Group1 Intervention
Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,339,984 Total Patients Enrolled
36 Trials studying Chronic Pain
7,862 Patients Enrolled for Chronic Pain
Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,996,087 Total Patients Enrolled
9 Trials studying Chronic Pain
5,919 Patients Enrolled for Chronic Pain
Beth Darnall, Ph.D.Principal Investigator - Stanford University
Stanford University

Media Library

Chronic Pain Research Study Groups: Chronic Pain Self Management Program, Taper Only (Usual Care), Observational Arm, Cognitive Behavioral Therapy
Chronic Pain Clinical Trial 2023: Chronic Pain Self Management Program Highlights & Side Effects. Trial Name: NCT03445988 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are actively involved in the current clinical experiment?

"Affirmative. According to the information provided on clinicaltrials.gov, this trial is still open and inviting participants since it's release in July of 2018. Up until October 24th 2022 this study has been actively recruiting 1365 volunteers from a single site."

Answered by AI

Are recruits currently being sought for this study?

"Affirmative. According to the data uploaded onto clinicaltrials.gov, this study is at present gathering participants for evaluation. The trial was first initiated on July 24th 2018 and most recently updated on October 24th 2022; 1365 patients are required from just one medical facility."

Answered by AI

Are octogenarians eligible for enrollment in this study?

"This trial has age limitations set, with the youngest participant being 18 years old and the oldest allowed to join capped at 85."

Answered by AI

What criteria must participants meet to join this research project?

"The current trial is seeking 1,365 individuals aged between 18 and 85 who suffer from chronic non-cancer pain (lasting at least 6 months)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Cognitive Behavioral Therapy and Chronic Pain Self-Management Within the Context of Opioid Reduction: The EMPOWER Study
Beth Darnall 2018. "Cognitive Behavioral Therapy and Chronic Pain Self-Management Within the Context of Opioid Reduction: The EMPOWER Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03445988.
~203 spots leftby Apr 2025
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