Mindfulness-based cognitive therapy / Depression / Chronic Pain · Interventional Study

Mindfulness-based Cognitive Therapy for the Chronic Pain-depression Co-morbidity Among Older Black Adults in the Community; The Quiet Focus Open Pilot

ClinicalTrials.gov · August 19, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed open pilot study of mindfulness-based cognitive therapy adapted for older Black adults with chronic pain and depression. No results are posted in this registry record. The study enrolled 12 participants to assess credibility, satisfaction, and patient-reported change over 8 weeks with 3-month follow-up, with the explicit aim of informing design of a future randomized controlled trial.

What was studied

Interventional, Single Group, Open label, Other purpose. Chronic Pain, Depression; age from 50 Years; to 120 Years. Intervention: Mindfulness-based cognitive therapy. n = 12. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an open pilot feasibility study with 12 participants and no reported results; it is designed to inform a future RCT and does not yet provide efficacy data.

Study design

As stated by the source record.

MethodsPrimary outcome measures: The Credibility and Expectancy Questionnaire (assessed at Baseline (at enrollment, prior to intervention initiation).); The Client Satisfaction Questionnaire (assessed at Administered at the end of treatment at 8 weeks.); Modified Patient Global Impression of Change (assessed at At end of 8 week program (post test) and again at 3 month follow up visit.)

DesignInterventional, Single Group, Open label, Other purpose

PopulationChronic Pain, Depression; age from 50 Years; to 120 Years

Sample size12

InterventionMindfulness-based cognitive therapy

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Sample size12

Primary outcome 1The Credibility and Expectancy Questionnaire, at baseline prior to intervention

Primary outcome 2The Client Satisfaction Questionnaire, at 8 weeks end of treatment

Primary outcome 3Modified Patient Global Impression of Change, at 8 weeks and 3-month follow-up

Treatment duration8 weeks

Caveats

No results reported in this registry record; outcomes have not been published or posted.
Open pilot design without a control or comparison arm; causality cannot be inferred.
Small sample (N=12) limits generalizability and statistical power.
Study explicitly positioned as a pilot to inform future RCT design, not as a definitive efficacy trial.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Open pilot design without control group or blinding; no randomization reported.

Directness

moderate

Targets chronic pain and depression in intended population; primary outcomes are feasibility and satisfaction measures, not clinical efficacy.

Consistency

insufficient

Single study; no results reported to compare against other trials.

Risk of bias

limited

Open design and small sample introduce risk of bias; no masking or control arm.

Sample adequacy

limited

N=12 enrolled and completed; pilot size appropriate for feasibility but underpowered for efficacy claims.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07336342). This is a study registration, not published results. Lead sponsor: Massachusetts General Hospital. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 12 participants (ACTUAL). Conditions: Chronic Pain, Depression. Interventions: BEHAVIORAL: Mindfulness-based cognitive therapy. Primary outcome measures: The Credibility and Expectancy Questionnaire , Baseline (at enrollment, prior to intervention initiation).; The Client Satisfaction Questionnaire , Administered at the end of treatment at 8 weeks.; Modified Patient Global Impression of Change , At end of 8 week program (post test) and again at 3 month follow up visit.. 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?

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07336342Mindfulness-based cognitive therapyDepressionMassachusetts General HospitalChronic Pain