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Effectiveness of Acceptance and Commitment Therapy for Chronic Non-Malignant Pain: A Randomized Controlled Trial

2026年7月12日 更新者:Ambreen Ishaq、GIFT University
This study is evaluating whether Acceptance and Commitment Therapy (ACT) helps adults with chronic non-malignant pain (pain lasting 3 months or longer that is not caused by cancer). Sixty adult participants (ages 18-60) were randomly placed into one of three groups: ACT, Cognitive Behavioral Therapy (CBT), or Treatment as Usual (TAU, standard medical care only). Both ACT and CBT are delivered over 10 weekly sessions by a trained therapist. ACT focuses on helping people accept pain-related thoughts and feelings, become less controlled by unhelpful thinking patterns, and take action toward things that matter to them despite pain. CBT focuses on changing unhelpful thoughts about pain and building coping skills such as pacing and relaxation. The TAU group continues usual medical care without added psychological treatment. Participants complete questionnaires before and after treatment measuring pain intensity, pain acceptance, pain-related disability, psychological flexibility, catastrophic thinking about pain, anxiety, depression, and quality of life. The goal is to find out whether ACT works as well as, or better than, CBT, and whether either treatment works better than standard care alone.

調査の概要

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

介入

入学 (実際)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Punjab Province
      • Guiranwala、Punjab Province、パキスタン、52250
        • DHQ Hospital, Gujranwala (Orthopedic Department)

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

いいえ

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

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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
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.
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.
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.
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.
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.

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
Change in Pain Acceptance
時間枠:Baseline and post-intervention (Week 10)
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.
Baseline and post-intervention (Week 10)
Change in Psychological Flexibility
時間枠:Baseline and post-intervention (Week 10)
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.
Baseline and post-intervention (Week 10)
Change in Pain Interference
時間枠:Baseline and post-intervention (Week 10)
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.
Baseline and post-intervention (Week 10)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Pain Intensity
時間枠:Baseline and post-intervention (Week 10)
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").
Baseline and post-intervention (Week 10)
Change in Pain Catastrophizing
時間枠:Baseline and post-intervention (Week 10)
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.
Baseline and post-intervention (Week 10)
Change in Anxiety Symptoms
時間枠:Baseline and post-intervention (Week 10)
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.
Baseline and post-intervention (Week 10)
Change in Depression Symptoms
時間枠:Baseline and post-intervention (Week 10)
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.
Baseline and post-intervention (Week 10)
Change in Quality of Life
時間枠:Baseline and post-intervention (Week 10)
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.
Baseline and post-intervention (Week 10)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

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

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月13日

一次修了 (推定)

2026年7月26日

研究の完了 (推定)

2026年7月31日

試験登録日

最初に提出

2026年7月12日

QC基準を満たした最初の提出物

2026年7月12日

最初の投稿 (実際)

2026年7月16日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月16日

QC基準を満たした最後の更新が送信されました

2026年7月12日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

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?

未定

IPD プランの説明

A formal data-sharing plan has not yet been established. This is a student thesis-based clinical trial, and decisions regarding individual participant data (IPD) sharing will depend on institutional policy, ethical approval conditions, and participant consent terms at the time of study completion.

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