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| ID | Type | Description | Link |
|---|---|---|---|
| K23AT012363 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quiet Focus | Experimental |
| |
| Health Enhancement Program | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quiet Focus | Behavioral | Mindfulness-based cognitive therapy adapted for older adults at-risk for chronic pain and depression |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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. | At end of 8 week program (post test) and again at 3 month follow up visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 3 months from the end of treatment at 8 weeks |
| PROMIS Physical Function |
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Participant Inclusion Criteria
Participant Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tony V Pham | Contact | 617-800-9988 | tonyvpham@mgh.harvard.edu | |
| Tony V Pham | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Tony V Pham | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
All IPD collected throughout the trial.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D003863 | Depression |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Health Enhancement Program | Behavioral | Time- and dose-matched control for Quiet Focus. |
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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. |
| 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | 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. | From enrollment to 3 months from the end of treatment at 8 weeks |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |