Chronic PainNCT07785648
Mindfulness-Based Cognitive Therapy Vs. the Health Enhancement Program for Chronic Pain and Early Cognitive Decline; The Feeling of Being Pilot RCT
A study testing Feeling of Being and Health Enhancement Program in people with Chronic Pain and Mild Cognitive Impairment, 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 early cognitive decline. Read more about this study
- Who is it for?
- Ages 50 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Mild Cognitive Impairment
- What is being tested?
- Feeling of Being 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
- 18 Oct 2026to 17 Sep 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Early Cognitive Decline (subjective or MCI)
- Telephone Interview for Cognitive Status-41 score ≥ 26
- Functional Activities Questionnaire score < 9
Show all 9Show fewer
- English fluency/literacy
- Ability and willingness to participate via in-person and video
- Willing to provide informed consent and comply with all aspects of the protocol
Who cannot join
- 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 or self-harm within the past 90 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kelly Horan, 617-726-2000, khoran@mgb.org
About this study
Official title: Mindfulness-based Cognitive Therapy vs the Health Enhancement Program for Chronic Pain and Early Cognitive Decline; The Feeling of Being 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 early cognitive decline. 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 and early cognitive decline 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, Mild Cognitive Impairment
- Being tested
- Feeling of Being, Health Enhancement Program
- Keywords
- mindfulness-based cognitive therapy, mind-body, chronic pain, early cognitive decline, older adult
- Medical subject headings
- Chronic Pain, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeling of BeingBehavioural
Mindfulness-based cognitive therapy adapted for older adults at-risk for chronic pain and early cognitive decline
Health Enhancement ProgramBehavioural
Time- and dose-matched control for Feeling of Being.
| Study group | Role | What they receive |
|---|---|---|
| Quiet Focus | Experimental | Not described Receives: Behavioral: Feeling of Being |
| 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 Client Satisfaction Questionnaire
The 3-item version of the Client Satisfaction Questionnaire (CSQ-3) is scored by summing responses from its three core items. It consists of empirically selected items measuring key aspects of service satisfaction, each rated on a 4-point Likert scale (1 = lowest satisfaction to 4 = highest, with directionality adjusted as needed). Total scores range from 3 to 12, with higher values indicating greater satisfaction; no reverse scoring or subscales are required.
Measured: Administered at the end of treatment at 8 weeks.
The Credibility and Expectancy Questionnaire
The Credibility/Expectancy Questionnaire (CEQ) is a 6-item self-report measure assessing treatment credibility (items 1-3) and expectancy (items 4-6). Items 1-3 and 5 are rated 0 (not at all credible/logical) to 9 (extremely credible/logical), while items 4 and 6 are rated 0% to 100%; subscale scores are standardized and summed (credibility: 3-27 raw equivalent; expectancy similar), with total scores ranging 6-54 after standardization, where higher scores indicate greater credibility and positive outcome expectancy (better outcome).
Measured: At enrollment
Modified Patient Global Impression of Change
The Modified Patient Global Impression of Change (mPGIC) adapts the standard single-item Patient Global Impression of Change (PGIC), a validated patient-reported outcome measure of overall perceived change since intervention, by assessing change across six specific domains. Each domain uses a single ordinal item rated on a 7-point scale: Very Much Improved (coded 1), Much Improved (2), Minimally Improved (3), No Change (4), Minimally Worse (5), Much Worse (6) or Very Much Worse (7). The range per domain is 0 (worst, Much Worse) to 5 (best, Very Much Improved), with higher scores indicating greater perceived improvement. Domains are analyzed individually as mean scores (no total computed), where values <4 reflect net positive change. Domains include coping strategies, physical activity, social activity, level of stress, memory and thinking, and pain.
Measured: At end of 8 week program (post test) and again at 3 month follow up visit.
Secondary outcomes (13)
Numerical Rating Scale
The Numerical Rating Scale (NRS) for pain intensity is an 11-point scale from 0 (no pain) to 10 (worst imaginable pain), assessing average pain over the past week. Higher scores indicate greater pain intensity (worse outcome), lower scores less pain (better); single-item total score.
Measured: From enrollment to 3 months from the end of treatment at 8 weeks.
PROMIS Physical Function
The PROMIS Short Form V2.0 - Physical Function 8B (PROMIS PF 8B v2.0) is an 8-item patient-reported outcome measure assessing self-reported capability in physical activities, including upper extremity function (e.g., hand/arm tasks), lower extremity function (e.g., walking), central body function, and daily activities. It uses a 5-point Likert response scale per item: Without any difficulty (5), With little difficulty (4), With some difficulty (3), With much difficulty (2), or Unable to do/Cannot do (1). Raw total scores range from 8 (severe difficulty, worst outcome) to 40 (no difficulty, best outcome); these convert via scoring tables to T-scores (mean=50, SD=10 in U.S. population), where higher T-scores indicate better physical function. No subscales are computed; the total score reflects overall physical function. The T-score range for the PROMIS SF V1.2 is 10-65.
Measured: From enrollment to 3 months from the end of treatment at 8 weeks.
PROMIS Anxiety
From enrollment to 3 months from the end of treatment at 8 weeks
Measured: The PROMIS Short Form V1.0 - Emotional Distress Anxiety 8a (PROMIS Anxiety SF 8a v1.0) is an 8-item patient-reported outcome measure assessing self-reported anxiety symptoms over the past 7 days, including fear, nervousness, worry, dread, and feeling ten
PROMIS Emotional Support
The PROMIS Short Form V2.0 - Emotional Support 8a (PROMIS Emotional Support SF 8a v2.0) is an 8-item patient-reported outcome measure assessing perceived availability of supportive interpersonal relationships over the past 7 days, including listening, confiding, appreciation, understanding, and trust. It uses a 5-point Likert response scale per item: Never (1), Rarely (2), Sometimes (3), Often (4), or Always (5). Raw total scores range from 8 (minimal support, worst outcome) to 40 (strong support, best outcome); these convert via scoring tables to T-scores (mean=50, SD=10 in U.S. population), where higher T-scores indicate greater emotional support. No subscales are computed; the total score reflects overall perceived support. T-score range: 25-75 for the 8a short form.
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 Measure of Current Status Part A (MOCS-A) comprises 13 items rated 0 (cannot do at all) to 4 (extremely well), summed for total score 0-52, with four subscales: relaxation, tension awareness, assertiveness, coping confidence (higher total/subscale scores indicate better stress management ability, better outcome). Each item is 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.
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) is a 12-item scale rated 1 (rarely/not at all) to 4 (almost always), total score summed 12-48 (higher scores indicate greater mindfulness ability, better outcome); unidimensional total score. Scoring: Items 2, 6, and 7 are reverse-scored. After appropriate reversals, sum values for items 1-12. Higher values reflect greater mindful qualities.
Measured: From enrollment to 3 months from the end of treatment at 8 weeks.
Chronic Pain Acceptance Questionnaire
The Chronic Pain Acceptance Questionnaire (CPAQ) sums 20 items rated 0 (never true) to 6 (always true) for total raw score 0-120, with two subscales: Activity Engagement (0-66) and Pain Willingness (0-54), both/totals higher indicating greater pain acceptance (better outcome).
Measured: From enrollment to 3 months from the end of treatment at 8 weeks.
Pain Self-Efficacy Questionnaire
The Pain Self-Efficacy Questionnaire (PSEQ) consists of 10 items rated 0 (not at all confident) to 6 (completely confident), summed for total 0-60. Higher scores indicate greater self-efficacy despite pain (better outcome); single total score.
Measured: From enrollment to 3 months from the end of treatment at 8 weeks
Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) sums 13 items rated 0 (not at all) to 4 (all the time) for total 0-52, with subscales: Rumination (0-16), Magnification (0-12), Helplessness (0-24); higher scores indicate greater catastrophizing (worse outcome).
Measured: From enrollment to 3 months from the end of treatment at 8 weeks.
Tampa Kinesiophobia Scale
The Tampa Scale of Kinesiophobia (TSK-11) sums 11 items rated 1 (strongly disagree) to 4 (strongly agree), with no reverse-coded items. Total score range: 11-44 (higher scores greater kinesiophobia/fear of movement, worse outcome).
Measured: From enrollment to 3 months from the end of treatment at 8 weeks
PROMIS Depression
The PROMIS Short Form V1.0 - Emotional Distress Depression 8b (PROMIS Depression SF 8b v1.0) is an 8-item patient-reported outcome measure assessing self-reported depressive symptoms over the past 7 days, including feelings of worthlessness, helplessness, sadness, failure, depression, unhappiness, and hopelessness. It uses a 5-point Likert response scale per item: Never (1), Rarely (2), Sometimes (3), Often (4), or Always (5). Raw total scores range from 8 (minimal depression, best outcome) to 40 (severe depression, worst outcome); these convert via scoring tables to T-scores (mean=50, SD=10 in U.S. population), where higher T-scores indicate greater depression severity. No subscales are computed; the total score reflects overall depressive distress. T-score range: 42-84.
Measured: From enrollment to 3 months from the end of treatment at 8 weeks.
Telephone Interview for Cognitive Status (41-point version)
The Telephone Interview for Cognitive Status (41-point version) sums 11 items (e.g., orientation, memory, attention) for total score 0-41, with higher scores indicating better global cognitive function (better outcome).
Measured: From enrollment to 3 months from the end of treatment at 8 weeks.
The Everyday Cognition Scale (12-item version)
The Everyday Cognition Scale (ECog-12) is a 12-item informant-rated questionnaire assessing self-reported changes in everyday cognitive and functional abilities, sensitive to early decline in domains like memory, executive function, and organization. Each item uses a 4-point ordinal scale: 1 = No change (better or same), 2 = Occasionally worse, 3 = Consistently worse, 4 = Much worse. Higher ratings indicate greater perceived decline; "don't know" responses are typically prorated or handled per study protocol. The total score is the mean (average) of the 12 item scores, accounting for any missing data by dividing the sum by completed items. Scores range from 1.0 (no decline) to 4.0 (maximum impairment), with means around 1.5-2.0 in cognitively unimpaired participants.
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 posted25 Aug 2026
- Study start18 Oct 2026 (estimated)
- Primary completion18 Nov 2027 (estimated)
- Study completion17 Sep 2028 (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 Institute on Aging (NIA)
- 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
- NCT07785648
- Sponsor's protocol ID
- 2026P002003
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An 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 vs the Health Enhancement Program for Chronic Pain and Early Cognitive Decline; The Feeling of Being Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07785648
- Acronym / sponsor ID
- 2026P002003
- Conditions
- Chronic Pain, Mild Cognitive Impairment
- Keywords
- mindfulness-based cognitive therapy, mind-body, chronic pain, early cognitive decline, older adult
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 18 Oct 2026 (estimated)
- Primary completion
- 18 Nov 2027 (estimated)
- Study completion
- 17 Sep 2028 (estimated)
- First posted
- 25 Aug 2026 (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 early cognitive decline. 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 and early cognitive decline 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: Feeling of Being |
| Health Enhancement Program | Active comparator | Behavioral: Health Enhancement Program |
Who may qualify
- Ages
- 50 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Early Cognitive Decline (subjective or MCI)
- Telephone Interview for Cognitive Status-41 score ≥ 26
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Feeling of BeingMindfulness-based cognitive therapy adapted for older adults at-risk for chronic pain and early cognitive decline | Behavioural | Quiet Focus |
| Health Enhancement ProgramTime- and dose-matched control for Feeling of Being. | Behavioural | Health Enhancement Program |
Primary outcome
The Client Satisfaction Questionnaire
Time frame: Administered at the end of treatment at 8 weeks.
The 3-item version of the Client Satisfaction Questionnaire (CSQ-3) is scored by summing responses from its three core items. It consists of empirically selected items measuring key aspects of service satisfaction, each rated on a 4-point Likert scale (1 = lowest satisfaction to 4 = highest, with directionality adjusted as needed). Total scores range from 3 to 12, with higher values indicating greater satisfaction; no reverse scoring or subscales are required.
The Credibility and Expectancy Questionnaire
Time frame: At enrollment
The Credibility/Expectancy Questionnaire (CEQ) is a 6-item self-report measure assessing treatment credibility (items 1-3) and expectancy (items 4-6). Items 1-3 and 5 are rated 0 (not at all credible/logical) to 9 (extremely credible/logical), while items 4 and 6 are rated 0% to 100%; subscale scores are standardized and summed (credibility: 3-27 raw equivalent; expectancy similar), with total scores ranging 6-54 after standardization, where higher scores indicate greater credibility and positive outcome expectancy (better outcome).
Modified Patient Global Impression of Change
Time frame: At end of 8 week program (post test) and again at 3 month follow up visit.
The Modified Patient Global Impression of Change (mPGIC) adapts the standard single-item Patient Global Impression of Change (PGIC), a validated patient-reported outcome measure of overall perceived change since intervention, by assessing change across six specific domains. Each domain uses a single ordinal item rated on a 7-point scale: Very Much Improved (coded 1), Much Improved (2), Minimally Improved (3), No Change (4), Minimally Worse (5), Much Worse (6) or Very Much Worse (7). The range per domain is 0 (worst, Much Worse) to 5 (best, Very Much Improved), with higher scores indicating greater perceived improvement. Domains are analyzed individually as mean scores (no total computed), where values <4 reflect net positive change. Domains include coping strategies, physical activity, social activity, level of stress, memory and thinking, and pain.
13 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 Anxiety
Time frame: The PROMIS Short Form V1.0 - Emotional Distress Anxiety 8a (PROMIS Anxiety SF 8a v1.0) is an 8-item patient-reported outcome measure assessing self-reported anxiety symptoms over the past 7 days, including fear, nervousness, worry, dread, and feeling ten
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
PROMIS Depression
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks.
Telephone Interview for Cognitive Status (41-point version)
Time frame: From enrollment to 3 months from the end of treatment at 8 weeks.
The Everyday Cognition Scale (12-item version)
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. An 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 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 Feeling of Being and Health Enhancement Program in people with Chronic Pain and Mild Cognitive Impairment, 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?
The sponsor lists 9 inclusion and 6 exclusion criteria. 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: opening soon, 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 Client Satisfaction Questionnaire (time frame: Administered at 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.