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

Официальное название

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

Обзор

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?

Подробное описание

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.

Вмешательства

• Поведенческое Quiet Focus
  Mindfulness-based cognitive therapy adapted for older adults at-risk for chronic pain and depression
• Поведенческое Health Enhancement Program
  Time- and dose-matched control for Quiet Focus.

Первичные конечные точки

• The Credibility and Expectancy Questionnaire [Срок оценки: From enrollment to 3 months from the end of treatment at 8 weeks]
• The Client Satisfaction Questionnaire [Срок оценки: Administered at the end of treatment at 8 weeks and at the three month follow up visit]
• Modified Patient Global Impression of Change [Срок оценки: At end of 8 week program (post test) and again at 3 month follow up visit]

Вторичные конечные точки (11)

• Numerical Rating Scale [Срок оценки: From enrollment to 3 months from the end of treatment at 8 weeks]
• PROMIS Physical Function [Срок оценки: From enrollment to 3 months from the end of treatment at 8 weeks]
• PROMIS Depression [Срок оценки: From enrollment to 3 months from the end of treatment at 8 weeks]
• PROMIS Anxiety [Срок оценки: From enrollment to 3 months from the end of treatment at 8 weeks]
• PROMIS Emotional Support [Срок оценки: From enrollment to 3 months from the end of treatment at 8 weeks]
• Measure of Current Status Part A [Срок оценки: From enrollment to 3 months from the end of treatment at 8 weeks]
• Cognitive and Affective Mindfulness Scale-Revised [Срок оценки: From enrollment to 3 months from the end of treatment at 8 weeks]
• Chronic Pain Acceptance Questionnaire [Срок оценки: From enrollment to 3 months from the end of treatment at 8 weeks]
• Pain Self-Efficacy Questionnaire [Срок оценки: From enrollment to 3 months from the end of treatment at 8 weeks]
• Pain Catastrophizing Scale [Срок оценки: From enrollment to 3 months from the end of treatment at 8 weeks]
• Tampa Kinesiophobia Scale [Срок оценки: From enrollment to 3 months from the end of treatment at 8 weeks]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT07118722 · 2025P001670 · K23AT012363

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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