Pain Disengagement Training (Open Pilot)

Официальное название

Pain Disengagement Training: A Self-directed Intervention for Pain Catastrophizing (Open Pilot)

Обзор

The investigators aim to conduct an open pilot trial to determine the initial feasibility of a self-directed writing-based intervention in individuals with chronic musculoskeletal pain and elevated pain catastrophizing. The investigators will assess the feasibility of recruitment, acceptability of the treatment, credibility and participant satisfaction, treatment adherence, and feasibility of assessments following pre-specified benchmarks.

Подробное описание

Mind-body interventions are some of the most effective treatments for chronic pain, yet due to lack of resources, many are inaccessible to the patients who need them. The investigators seek to fill this gap by developing and testing Pain Disengagement Training (PDT) for the treatment of chronic pain catastrophizing, a key risk factor for pain interference. The investigators will administer the PDT treatment in a small number (approximately 10) of participants to evaluate initial benchmarks (the feasibility of recruitment, acceptability of the treatment, credibility and participant satisfaction, treatment adherence, and feasibility of assessments) and to assess participants' experience with the intervention using qualitative exit interviews. Results will inform the refinement of the intervention for a future larger trial.

Вмешательства

• Поведенческое Pain Disengagement Training
  The intervention involves approximately 8 sessions. The first session will involve a psychoeducation component describing the association between negative emotions and pain and the rationale for the intervention strategies. The intervention sessions will consist of approximately 30 minutes of writing alternating between imaginal exposure writing and positive writing periods alternating back and forth (e.g., 3-5 minutes of imaginal exposure writing followed by 3-5 minutes of positive writing befo

Первичные конечные точки

• Feasibility of recruitment [Срок оценки: Baseline, post-test (6 weeks)]
• Acceptability of treatment [Срок оценки: Baseline, post-test (6 weeks)]
• Credibility and Expectancy Questionnaire [Срок оценки: Baseline]
• Client Satisfaction Questionnaire [Срок оценки: Post-test (6 weeks)]
• Adherence to intervention [Срок оценки: Mid-intervention]
• Feasibility of assessments [Срок оценки: Baseline, post-test (6 weeks)]

Вторичные конечные точки (12)

• Numerical Rating Scale [Срок оценки: Baseline, post-test (6 weeks)]
• Graded Chronic Pain Scale [Срок оценки: Baseline, post-test (6 weeks)]
• PROMIS Pain Interference scale [Срок оценки: Baseline, post-test (6 weeks)]
• Brief Pain Inventory [Срок оценки: Baseline, post-test (6 weeks)]
• Patient Health Questionnaire - 9 [Срок оценки: Baseline, post-test (6 weeks)]
• PROMIS depression scale-8 [Срок оценки: Baseline, post-test (6 weeks)]
• Penn State Worry Questionnaire - abbreviated [Срок оценки: Baseline, post-test (6 weeks)]
• Pain Catastrophizing Scale [Срок оценки: Baseline, post-test (6 weeks)]
• Pain Anxiety Symptom Scale - Short Form (PASS-20) [Срок оценки: Baseline, post-test (6 weeks)]
• Worry Disengagement Questionnaire [Срок оценки: Baseline, post-test (6 weeks)]
• Behavioral Activation for Depression Scale - Short Form [Срок оценки: Baseline, post-test (6 weeks)]
• Positive emotion rating scale [Срок оценки: Mid-intervention]

Критерии участия

Критерии включения

• Outpatient adults (i.e., greater than or equal to 18)
• Has self reported chronic musculoskeletal pain (i.e., pain persisting for at least 3 months)
• Pain score greater than or equal to 4 (moderate) on the Numerical Rating Scale
• Pain catastrophizing score greater than or equal to 20 on Pain Catastrophizing Scale
• Willingness to engage in a writing-based intervention and self-reported ability to write or type for at least 30 minutes in a sitting
• Received care at Massachusetts General Hospital
• English verbal and writing fluency

Критерии исключения

• Clinically significant change in therapy or medication in the past 3 months
• Severe untreated mental health condition (e.g., psychosis)
• Active suicidality with history of plan or current intent
• Serious illness expected to worsen in the next 6 months (e.g., cancer)
• Untreated substance use problem that, per patient's self-report, would interfere with the ability to complete the intervention.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT06870162 · 2025p000348 · 1K23AT012789-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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