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Mindfulness-based Cognitive Therapy vs the Health Enhancement Program for Chronic Pain and Depression; The Quiet Focus Study

Mindfulness-Based Cognitive Therapy Adapted for Older Adults At-Risk for the Chronic Pain-Depression Co-Morbidity; The Quiet Focus Pilot Randomized Controlled Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 120 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study compares mindfulness-based cognitive therapy, which combines awareness and thinking skills, with a health enhancement program. It is for Black adults age 50 or older with long-lasting pain and depression. It will help plan a larger study on quality of life and how much pain gets in the way of daily life.

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?

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 50 or older.
  • Identify with one or more national or ethnic groups rooted in the Black racial groups of Africa.
  • Have pain in muscles, joints, bones, or nearby soft tissues for more than 3 months, with a pain rating above 4.
  • Have a score of 5–14 on the PHQ-9, a questionnaire about depression.
  • Can speak and read English fluently.
  • Can and will take part both in person and by video.
  • Have had no change in antidepressant drug type or dose for at least 6 weeks before screening.
  • Agree to join after learning about the study and will follow all study rules.

Who can't join

  • Have more serious depression symptoms, with a PHQ-9 score of 15 or higher.
  • Currently misuse or depend on alcohol or drugs.
  • Have major problems with memory or thinking.
  • Have had more than 8 sessions of cognitive-behavioral therapy, which helps change thought and behavior patterns.
  • Have had mindfulness training before, or currently have counseling more than once a month.
  • Have or have had psychosis, a condition that makes it hard to tell what is real.
  • Currently have thoughts of suicide, or have harmed yourself in the past 90 days.
  • Are currently in another clinical trial that studies behavior-based treatments.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

MA