Recruiting

Mindfulness-Based Cognitive Therapy

Sponsor:

Massachusetts General Hospital

Code:

NCT07118722

Conditions

Chronic Pain

Depression

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Quiet Focus

Health Enhancement Program

Study Details

Brief summary:

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

Study ID

NCT07118722

Start date

Sep 1, 2025

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Participant Inclusion Criteria

1. 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

1. 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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Quiet Focus

active comparator: Health Enhancement Program

Interventions

Quiet Focus

Mindfulness-based cognitive therapy adapted for older adults at-risk for chronic pain and depression

Health Enhancement Program

Time- and dose-matched control for Quiet Focus.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • mindfulness-based cognitive therapy
  • mind-body
  • chronic pain
  • depression
  • older adult

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-08-25.