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

NCT07709572 | Active Not Recruiting

• 1 other identifier: GIFT/PSY/MS/2025/002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Non-Malignant Pain (Chronic Musculoskeletal Pain, Chronic Widespread Pain)

Keywords

Acceptance and Commitment Therapy; Cognitive Behavioral Therapy; Chronic Non-Malignant Pain; Chronic Musculoskeletal Pain; Chronic Widespread Pain; Psychological Flexibility; Pain Acceptance; Pain Catastrophizing; Randomized Controlled Trial; Quality of Life; Anxiety; Depression

Outcome Measures

Primary Outcomes (3)

• Change in Pain Acceptance

  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

  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

  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)

Secondary Outcomes (5)

• Change in Pain Intensity

  Baseline and post-intervention (Week 10)

• Change in Pain Catastrophizing

  Baseline and post-intervention (Week 10)

• Change in Anxiety Symptoms

  Baseline and post-intervention (Week 10)

• Change in Depression Symptoms

  Baseline and post-intervention (Week 10)

• Change in Quality of Life

  Baseline and post-intervention (Week 10)

Study Arms (3)

ACT (Acceptance and Commitment Therapy)

EXPERIMENTAL

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.

Behavioral: Acceptance and Commitment Therapy (ACT)

CBT (Cognitive Behavioral Therapy)

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Behavioral Therapy (CBT)

TAU (Treatment as Usual)

NO INTERVENTION

Participants in this arm continue their routine medical/pharmacological care for chronic pain without receiving any structured psychological intervention as part of the study.

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

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.

ACT (Acceptance and Commitment Therapy)

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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.

CBT (Cognitive Behavioral Therapy)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• GIFT University: lead

Study Sites (1)

DHQ Hospital, Gujranwala (Orthopedic Department)

Guiranwala, Punjab Province, 52250, Pakistan

Location

MeSH Terms

Conditions

Chronic Pain; Anxiety Disorders; Depression

Interventions

Acceptance and Commitment Therapy; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ather Mujitaba, Phd

  GIFT University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors administering and scoring post-intervention questionnaires were blinded to participants' group allocation. Due to the nature of psychotherapy interventions, blinding of participants and treatment providers was not feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomly allocated to one of three parallel arms ACT, CBT, or TAU using manual simple randomization (fishbowl method), with 20 participants per arm. Each arm receives its assigned condition concurrently over the study period, with no crossover between groups. Outcomes are compared between arms at post-intervention.

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 16, 2026
• Study Start: May 13, 2026
• Primary Completion: July 26, 2026
• Study Completion: July 31, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

PA (1)