Effectiveness of Acceptance and Commitment Therapy for Chronic Non-Malignant Pain: A Randomized Controlled Trial
調査の概要
状態
詳細な説明
Chronic non-malignant pain (CNMP) is associated with significant psychological distress, functional impairment, and reduced quality of life, and pharmacological treatment alone often provides limited relief. This study uses a three-arm, single-blind randomized controlled trial with a pretest-posttest parallel-group design to compare Acceptance and Commitment Therapy (ACT) against Cognitive Behavioral Therapy (CBT, active comparator) and Treatment as Usual (TAU, control).
Sixty adults (aged 18-60) with a physician-confirmed diagnosis of chronic non-malignant musculoskeletal or widespread pain (duration ≥3 months) were enrolled using purposive sampling and randomly allocated to ACT, CBT, or TAU (n=20 per group) using manual simple randomization (fishbowl method). Eligible participants scored ≥4 on the Numerical Rating Scale (pain intensity), ≥4 on the Brief Pain Inventory interference subscale, and ≥20 on the Pain Catastrophizing Scale, and were willing/able to attend all sessions. Individuals with severe psychiatric disorders, severe cognitive/neurological impairment, concurrent structured psychological treatment for pain, or unstable medical conditions were excluded.
The ACT intervention, delivered over 10 weekly sessions using a manual-based protocol adapted for chronic pain, targets the six core processes of the psychological flexibility model: acceptance, cognitive defusion, present-moment awareness, self-as-context, values clarification, and committed action. The CBT intervention, also delivered over 10 weekly sessions, targets maladaptive pain-related cognitions and behaviors through cognitive restructuring, behavioral activation, activity pacing, relaxation training, problem-solving, and coping skills. The TAU group continues routine medical/pharmacological care without structured psychological intervention.
Outcome assessors are blinded to group allocation; participants and therapists could not be blinded given the nature of the interventions. Outcomes are assessed at baseline and post-intervention using the Numerical Rating Scale (pain intensity), Chronic Pain Acceptance Questionnaire (pain acceptance), Brief Pain Inventory (pain interference), Acceptance and Action Questionnaire-II (psychological flexibility), Pain Catastrophizing Scale, Hospital Anxiety and Depression Scale, and WHOQOL-BREF (quality of life). Data collection is complete for the majority of participants; a small number of participants are currently in their final follow-up sessions before post-intervention assessment.
The study aims to (1) evaluate within-group change in ACT and CBT from pretest to posttest across all outcomes; (2) compare ACT versus CBT on post-intervention outcomes, with primary focus on pain acceptance, psychological flexibility, and pain interference; (3) examine whether change in psychological flexibility predicts change in pain interference and catastrophizing across both treatment groups; (4) compare ACT and CBT on anxiety, depression, and quality of life; and (5) compare ACT and CBT against TAU on all outcome measures. Findings are expected to clarify the comparative efficacy and mechanism of action of ACT relative to an established active treatment, contributing evidence for non-pharmacological, mechanism-informed pain management, particularly within an under-studied Pakistani population.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Punjab Province
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Guiranwala、Punjab Province、パキスタン、52250
- DHQ Hospital, Gujranwala (Orthopedic Department)
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Chronic non-malignant musculoskeletal pain or chronic widespread pain persisting for at least three months, without evidence of malignant pathology Aged between 18 and 60 years Current pain severity of ≥4 on the Numerical Rating Scale (NRS) Pain-related functional interference of ≥4 on the Brief Pain Inventory (BPI) interference subscale Pain catastrophizing score of ≥20 on the Pain Catastrophizing Scale (PCS) Availability and willingness to attend all intervention sessions (10 weekly sessions for either ACT or CBT) Diagnosis medically confirmed by a qualified physician (e.g., orthopedic consultant or pain specialist) prior to inclusion
Exclusion Criteria:
Presence of severe psychiatric disorders, including but not limited to psychotic disorders, schizophrenia, or bipolar disorder Severe cognitive impairment or neurological disorders that may interfere with understanding or completing study assessments Concurrent participation in other structured psychological interventions for chronic pain (e.g., CBT, ACT) Uncontrolled or unstable medical conditions that may compromise safe participation in the study
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:ACT (Acceptance and Commitment Therapy)
Participants in this arm receive Acceptance and Commitment Therapy delivered over 10 weekly sessions using a manual-based protocol adapted for chronic pain.
The intervention targets six core processes: acceptance, cognitive defusion, present-moment awareness, self-as-context, values clarification, and committed action.
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A 10-session, manual-based psychological intervention targeting psychological flexibility through acceptance, cognitive defusion, present-moment awareness, self-as-context, values clarification, and committed action, delivered weekly by a trained therapist.
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アクティブコンパレータ:CBT (Cognitive Behavioral Therapy)
Participants in this arm receive Cognitive Behavioral Therapy delivered over 10 weekly sessions, targeting maladaptive pain-related cognitions and behaviors through cognitive restructuring, behavioral activation, activity pacing, relaxation training, problem-solving, and coping skills.
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A 10-session, manual-based psychological intervention targeting maladaptive pain-related cognitions and behaviors through cognitive restructuring, behavioral activation, activity pacing, relaxation training, problem-solving, and coping skills, delivered weekly by a trained therapist.
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介入なし:TAU (Treatment as Usual)
Participants in this arm continue their routine medical/pharmacological care for chronic pain without receiving any structured psychological intervention as part of the study.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Pain Acceptance
時間枠:Baseline and post-intervention (Week 10)
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Pain acceptance will be assessed using the Chronic Pain Acceptance Questionnaire (CPAQ), a 20-item self-report measure rated on a 7-point Likert scale (0 = "never true" to 6 = "always true"), with higher scores indicating greater acceptance.
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Baseline and post-intervention (Week 10)
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Change in Psychological Flexibility
時間枠:Baseline and post-intervention (Week 10)
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Psychological flexibility will be assessed using the Acceptance and Action Questionnaire-II (AAQ-II), a 7-item self-report measure rated on a 7-point Likert scale (1 = "never true" to 7 = "always true"), with higher scores indicating greater flexibility.
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Baseline and post-intervention (Week 10)
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Change in Pain Interference
時間枠:Baseline and post-intervention (Week 10)
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Pain interference will be assessed using the Pain Interference subscale of the Brief Pain Inventory (BPI), rated on a 0-10 scale, with higher scores indicating greater interference with daily functioning, mood, and social activities.
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Baseline and post-intervention (Week 10)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Pain Intensity
時間枠:Baseline and post-intervention (Week 10)
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Pain intensity will be assessed using the Numerical Rating Scale (NRS), a single-item measure ranging from 0 ("no pain") to 10 ("worst imaginable pain").
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Baseline and post-intervention (Week 10)
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Change in Pain Catastrophizing
時間枠:Baseline and post-intervention (Week 10)
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Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), a 13-item measure rated on a 5-point scale, with higher scores indicating greater catastrophizing.
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Baseline and post-intervention (Week 10)
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Change in Anxiety Symptoms
時間枠:Baseline and post-intervention (Week 10)
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Anxiety will be assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), a 7-item measure rated on a 0-3 scale.
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Baseline and post-intervention (Week 10)
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Change in Depression Symptoms
時間枠:Baseline and post-intervention (Week 10)
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Depression will be assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D), a 7-item measure rated on a 0-3 scale.
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Baseline and post-intervention (Week 10)
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Change in Quality of Life
時間枠:Baseline and post-intervention (Week 10)
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Quality of life will be assessed using the WHOQOL-BREF, a self-report measure assessing physical, psychological, social, and environmental domains of quality of life.
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Baseline and post-intervention (Week 10)
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協力者と研究者
スポンサー
捜査官
- スタディディレクター:Ather Mujitaba, Phd、GIFT University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- GIFT/PSY/MS/2025/002
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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