Mindfulness-based Cognitive Therapy for the Chronic Pain-depression Co-morbidity Among Older Black Adults in the Community; The Quiet Focus Open Pilot
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- The Credibility and Expectancy Questionnaire
Overview
Brief Summary
The goal of this clinical trial is to pilot an adaptation of mindfulness-based cognitive therapy 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?
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant 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
Arms & Interventions
Quiet Focus
Intervention: Quiet Focus (Behavioral)
Outcomes
Primary Outcomes
The Credibility and Expectancy Questionnaire
Time Frame: From enrollment to 3 months from the end of treatment at 8 weeks
This scale measures participant expectations around the study's positive outcomes, with measures ranging from 0 (not at all expected) to 9 (extremely expected). A higher score indicate greater trust in the study design and an openness to potential benefits.
The Client Satisfaction Questionnaire
Time Frame: Administered at the end of treatment at 8 weeks and at the three month follow up visit.
Three item scale measuring patient satisfaction with the program. Scores for each item range from 1 (unsatisfied) to 4 (very satisfied).
Modified Patient Global Impression of Change
Time Frame: At end of 8 week program (post test) and again at 3 month follow up visit.
Measures participant impressions of overall change with one being very much improved and eight being very much worse. Lower scores indicate improvement.
Secondary Outcomes
- Numerical Rating Scale(From enrollment to 3 months from the end of treatment at 8 weeks.)
- PROMIS Physical Function(From enrollment to 3 months from the end of treatment at 8 weeks)
- PROMIS Anxiety(From enrollment to 3 months from the end of treatment at 8 weeks)
- PROMIS Depression(From enrollment to 3 months from the end of treatment at 8 weeks)
- PROMIS Emotional Support(From enrollment to 3 months from the end of treatment at 8 weeks.)
- Measure of Current Status Part A(From enrollment to 3 months from the end of treatment at 8 weeks)
- Cognitive and Affective Mindfulness Scale-Revised(From enrollment to 3 months from the end of treatment at 8 weeks)
- Chronic Pain Acceptance Questionnaire(From enrollment to 3 months from the end of treatment at 8 weeks)
- Pain Self-Efficacy Questionnaire(From enrollment to 3 months from the end of treatment at 8 weeks)
- Pain Catastrophizing Scale(From enrollment to 3 months from the end of treatment at 8 weeks)
- Tampa Kinesiophobia Scale(From enrollment to 3 months from the end of treatment at 8 weeks)
Investigators
Tony V. Pham, MD
Principal Investigator and Psychiatrist
Massachusetts General Hospital