Mindfulness-based Cognitive Therapy vs the Health Enhancement Program for Chronic Pain and Depression; The Quiet Focus Study
Purpose
The goal of this clinical trial is to pilot a randomized controlled trial comparing an adaptation of mindfulness-based cognitive therapy to the health enhancement program for chronic pain and depression. The main questions it aims to answer in a later fully powered randomized controlled trial are: - Is an adaptation of mindfulness-based cognitive therapy for older Black adults able to improve quality of life? - Will an adapted mindfulness based cognitive therapy reduce pain interference to a greater degree than a traditional health enhancement program?
Conditions
- Chronic Pain
- Depression
Eligibility
- Eligible Ages
- Between 50 Years and 120 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Older adult (age ≥ 50) 2. All individuals who identify with one or more nationalities or ethnic groups originating in any of the Black racial groups of Africa 3. Pain in muscles, joints, bones, or associated soft tissues (NRS>4) lasting longer than 3 months 4. Depressed (PHQ-9 score of 5-14) 5. English fluency/literacy 6. Ability and willingness to participate via in-person and video 7. No change to type or dose of antidepressant medications for at least 6 weeks prior to screening 8. Willing to provide informed consent and comply with all aspects of the protocol Participant
Exclusion Criteria
- Moderately severe or severe depressive symptoms (PHQ-9 ≥ 15) 2. Current substance abuse/dependence 3. Significant cognitive impairment 4. History of more than 8 sessions of cognitive-behavioral therapy 5. History of previous training in mindfulness or undergoing counseling more than once a month 6. History of or current diagnosis of psychosis 7. Active suicidal ideation (PHQ-9 item #9 or otherwise reported during screening) or self-harm within the past 90 days 8. Current participation in another behavioral clinical trial
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Quiet Focus |
|
|
|
Active Comparator Health Enhancement Program |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
Detailed Description
Co-morbid chronic pain-depression is common among older Black adults and this co-morbidity worsens physical and emotional function. Access to evidence based non-pharmacological management is limited. Mindfulness based cognitive therapy (MBCT) is an evidence-based, non-pharmacological intervention that could address the chronic pain-depression co-morbidity among older Black adults, but it requires tailoring. The proposed study will establish the feasibility, acceptability and credibility of Quiet Focus, a cultural adaptation of MBCT aimed at the chronic pain-depression co-morbidity among older Black adults in the community.
