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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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

Other trials in United States

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.

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 groups in NCT07785648
Study groupRoleWhat they receive
Quiet FocusExperimentalNot described
Receives: Behavioral: Feeling of Being
Health Enhancement ProgramActive comparatorNot described
Receives: Behavioral: Health Enhancement Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  2. 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

  3. 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)
  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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.

  1. First posted25 Aug 2026
  2. Study start18 Oct 2026 (estimated)
  3. Primary completion18 Nov 2027 (estimated)
  4. Study completion17 Sep 2028 (estimated)

Resources

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)
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.

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.

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