Mindfulness-based Cognitive Therapy vs the Health Enhancement Program for Chronic Pain and Depression; The Quiet Focus Study
Recruiting · NCT07118722 · Interventional (participants receive a specific treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Health Enhancement ProgramQuiet Focus
What this trial is about
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?
Who can take part
Age range
50 Years to 120 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Older adult (age ≥ 50)
- All individuals who identify with one or more nationalities or ethnic groups originating in any of the Black racial groups of Africa
- Pain in muscles, joints, bones, or associated soft tissues (NRS\>4) lasting longer than 3 months
- Depressed (PHQ-9 score of 5-14)
- English fluency/literacy
- Ability and willingness to participate via in-person and video
- No change to type or dose of antidepressant medications for at least 6 weeks prior to screening
- 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)
- Current substance abuse/dependence
- Significant cognitive impairment
- History of more than 8 sessions of cognitive-behavioral therapy
- History of previous training in mindfulness or undergoing counseling more than once a month
- History of or current diagnosis of psychosis
- Active suicidal ideation (PHQ-9 item #9 or otherwise reported during screening) or self-harm within the past 90 days
- Current participation in another behavioral clinical trial
Where it is running
1 location listed across 1 US state.
- Massachusetts General Hospital - Boston, Massachusetts, United States