Chronic PainNCT07118722
Mindfulness-based Cognitive Therapy vs the Health Enhancement Program for Chronic Pain and Depression; The Quiet Focus Study
A study testing Quiet Focus and Health Enhancement Program in people with Chronic Pain and Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 120 years
- Conditions the study is for
- Chronic Pain, Depression
- What is being tested?
- Quiet Focus and Health Enhancement Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tony V Pham contact
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kelly Horan, 617-726-2000, khoran@mgb.org
About this study
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
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?
Read the 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.
- Conditions
- Chronic Pain, Depression
- Being tested
- Quiet Focus, Health Enhancement Program
- Keywords
- mindfulness-based cognitive therapy, mind-body, chronic pain, depression, older adult
- Medical subject headings
- Chronic Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quiet FocusBehavioural
Mindfulness-based cognitive therapy adapted for older adults at-risk for chronic pain and depression
Health Enhancement ProgramBehavioural
Time- and dose-matched control for Quiet Focus.
| Study group | Role | What they receive |
|---|---|---|
| Quiet Focus | Experimental | Not described Receives: Behavioral: Quiet Focus |
| Health Enhancement Program | Active comparator | Not described Receives: Behavioral: Health Enhancement Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Credibility and Expectancy Questionnaire
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.
Measured: From enrollment to 3 months from the end of treatment at 8 weeks
The Client Satisfaction Questionnaire
Three item scale measuring patient satisfaction with the program. Scores for each item range from 1 (unsatisfied) to 4 (very satisfied).
Measured: Administered at the end of treatment at 8 weeks and at the three month follow up visit
Modified Patient Global Impression of Change
Measures participant impressions of overall change with one being very much improved and eight being very much worse. Lower scores indicate improvement.
Measured: At end of 8 week program (post test) and again at 3 month follow up visit
Secondary outcomes (11)
Numerical Rating Scale
Numerical rating of pain with lower scores indicating less pain overall (0 = no pain) and higher scores indicating more pain (10 = worst ever pain) over the past week.
Measured: From enrollment to 3 months from the end of treatment at 8 weeks
PROMIS Physical Function
The PROMIS Physical Function raw score is calculated by summing item responses, each rated on a 5-point Likert scale where 1 = "Unable to do" and 5 = "Without any difficulty," with higher scores indicating better function. This raw score is then converted to a T-score using a standardized table, where 50 represents the average in the general population and 10 is the standard deviation.
Measured: From enrollment to 3 months from the end of treatment at 8 weeks
PROMIS Depression
The PROMIS Depression raw score is calculated by summing item responses, each rated on a 5-point Likert scale where 1 = "Never" and 5 = "Always," with higher scores indicating more severe depressive symptoms. This raw score is converted to a T-score using a standardized table, where 50 represents the average level in the general population and 10 is the standard deviation.
Measured: From enrollment to 3 months from the end of treatment at 8 weeks
PROMIS Anxiety
The PROMIS Anxiety raw score is calculated by summing item responses, each rated on a 5-point Likert scale where 1 = "Never" and 5 = "Always," with higher scores reflecting greater anxiety symptoms. The raw score is then converted to a T-score using a standardized scoring table, with 50 representing the population average and 10 as the standard deviation.
Measured: From enrollment to 3 months from the end of treatment at 8 weeks
PROMIS Emotional Support
The PROMIS Emotional Support raw score is calculated by summing item responses, each rated on a 5-point Likert scale where 1 = "Never" and 5 = "Always," with higher scores indicating greater perceived emotional support. This raw score is converted to a T-score using a standardized table, where 50 represents the average for the general population and 10 is the standard deviation.
Measured: From enrollment to 3 months from the end of treatment at 8 weeks
Measure of Current Status Part A
The Measure of Current Status Part A (MOCS-A) is a self-report questionnaire that measures ability to manage stress. The score is calculated by summing responses to each item, rated on a 5-point Likert scale where 0 = "I cannot do this at all" and 4 = "I can do this extremely well," with higher scores reflecting greater confidence in coping skills. The scale measures current perceived ability to manage stress across areas like relaxation, awareness of tension, assertiveness, and coping confidence.
Measured: From enrollment to 3 months from the end of treatment at 8 weeks
Cognitive and Affective Mindfulness Scale-Revised
The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) measures percieved ability to complete mindfulness tasks such as meditation, with a 0 being rarely/not at all and a 3 being almost always. Higher scores indicate greater ability to practice mindfulness skills.
Measured: From enrollment to 3 months from the end of treatment at 8 weeks
Chronic Pain Acceptance Questionnaire
The Chronic Pain Acceptance Questionnaire (CPAQ)*= raw score is calculated by summing responses to each item, rated on a 7-point Likert scale where 0 = "Never true" and 6 = "Always true," with higher scores indicating greater acceptance of chronic pain. The scale assesses two key areas: pain willingness(the ability to experience pain without trying to control or avoid it) and activity engagement (continuing meaningful activities despite pain).
Measured: From enrollment to 3 months from the end of treatment at 8 weeks
Pain Self-Efficacy Questionnaire
The Pain Self-Efficacy Questionnaire (PSEQ) measures confidence in engaging in activities despite chronic pain. Higher scores indicate greater confidence (6 = complete confidence) and lower scores indicate lower confidence (0 = not at all confident).
Measured: From enrollment to 3 months from the end of treatment at 8 weeks
Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) score is calculated by summing responses to each item, rated on a 5-point Likert scale where 0 = "Not at all" and 4 = "All the time," with higher scores indicating greater levels of catastrophic thinking related to pain. The scale measures three components of pain catastrophizing: rumination, magnification, and helplessness.
Measured: From enrollment to 3 months from the end of treatment at 8 weeks
Tampa Kinesiophobia Scale
The Tampa Kinesiophobia Scale (TKS) measures fear of movement and is calculated by summing responses to each item, rated on a 4-point Likert scale where 1 = "Strongly disagree" and 4 = "Strongly agree," with higher scores indicating greater fear of movement or reinjury due to physical activity.
Measured: From enrollment to 3 months from the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Sep 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Tony V. Pham, MD, Massachusetts General Hospital
- Investigators
- Tony V Pham, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118722
- Sponsor's protocol ID
- 2025P001670
- Other IDs
- K23AT012363
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07118722
- Acronym / sponsor ID
- 2025P001670
- Conditions
- Chronic Pain, Depression
- Keywords
- mindfulness-based cognitive therapy, mind-body, chronic pain, depression, older adult
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quiet Focus | Experimental | Behavioral: Quiet Focus |
| Health Enhancement Program | Active comparator | Behavioral: Health Enhancement Program |
Who may qualify
- Ages
- 50 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quiet FocusMindfulness-based cognitive therapy adapted for older adults at-risk for chronic pain and depression | Behavioural | Quiet Focus |
| Health Enhancement ProgramTime- and dose-matched control for Quiet Focus. | Behavioural | Health Enhancement Program |
Primary outcome
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tony V Pham contact
Tony V Pham principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quiet Focus and Health Enhancement Program in people with Chronic Pain and Depression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tony V Pham (617-800-9988, tonyvpham@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Credibility and Expectancy Questionnaire (time frame: From enrollment to 3 months from the end of treatment at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.