Mindfulness-based Cognitive Therapy vs the Health Enhancement Program for Chronic Pain and Depression; The Quiet Focus Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quiet Focus, Health Enhancement Program.
- Who it may be relevant to
- Registry conditions: Chronic Pain, Depression. Basic parameters: 50 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Mindfulness-Based Cognitive Therapy Adapted for Older Adults At-Risk for the Chronic Pain-Depression Co-Morbidity; The Quiet Focus Pilot Randomized Controlled Trial
Overview
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?
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.
Interventions
- Behavioral Quiet Focus
Mindfulness-based cognitive therapy adapted for older adults at-risk for chronic pain and depression - Behavioral Health Enhancement Program
Time- and dose-matched control for Quiet Focus.
Primary outcome measures
- The Credibility and Expectancy Questionnaire [Time frame: From enrollment to 3 months from the end of treatment at 8 weeks]
- The Client Satisfaction Questionnaire [Time frame: Administered at the end of treatment at 8 weeks and at the three month follow up visit]
- Modified Patient Global Impression of Change [Time frame: At end of 8 week program (post test) and again at 3 month follow up visit]
Secondary outcome measures (11)
- Numerical Rating Scale [Time frame: From enrollment to 3 months from the end of treatment at 8 weeks]
- PROMIS Physical Function [Time frame: From enrollment to 3 months from the end of treatment at 8 weeks]
- PROMIS Depression [Time frame: From enrollment to 3 months from the end of treatment at 8 weeks]
- PROMIS Anxiety [Time frame: From enrollment to 3 months from the end of treatment at 8 weeks]
- PROMIS Emotional Support [Time frame: From enrollment to 3 months from the end of treatment at 8 weeks]
- Measure of Current Status Part A [Time frame: From enrollment to 3 months from the end of treatment at 8 weeks]
- Cognitive and Affective Mindfulness Scale-Revised [Time frame: From enrollment to 3 months from the end of treatment at 8 weeks]
- Chronic Pain Acceptance Questionnaire [Time frame: From enrollment to 3 months from the end of treatment at 8 weeks]
- Pain Self-Efficacy Questionnaire [Time frame: From enrollment to 3 months from the end of treatment at 8 weeks]
- Pain Catastrophizing Scale [Time frame: From enrollment to 3 months from the end of treatment at 8 weeks]
- Tampa Kinesiophobia Scale [Time frame: From enrollment to 3 months from the end of treatment at 8 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT07118722 · 2025P001670 · K23AT012363