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

12. Juli 2026 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Punjab Province
      • Guiranwala, Punjab Province, Pakistan, 52250
        • DHQ Hospital, Gujranwala (Orthopedic Department)

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Aktiver Komparator: 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.
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Pain Acceptance
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Pain Intensity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ermittler

  • Studienleiter: Ather Mujitaba, Phd, GIFT University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

13. Mai 2026

Primärer Abschluss (Geschätzt)

26. Juli 2026

Studienabschluss (Geschätzt)

31. Juli 2026

Studienanmeldedaten

Zuerst eingereicht

12. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Juli 2026

Zuerst gepostet (Tatsächlich)

16. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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