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Chronic Non-Malignant Pain (Chronic Musculoskeletal Pain, Chronic Widespread Pain)NCT07709572

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

A study testing Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT) in people with Chronic Non-Malignant Pain (Chronic Musculoskeletal Pain, Chronic Widespread Pain), run by GIFT University at 1 site in Pakistan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePakistan
Study dates
13 May 2026to 31 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • DHQ Hospital, Gujranwala (Orthopedic Department)

    Chak One Hundred Seventy-five Nine Left, Punjab Province, 52250

Other trials in Pakistan

About this study

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.

Read the detailed description

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.

Being tested
Acceptance and Commitment Therapy (ACT), Cognitive Behavioral Therapy (CBT)
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
Medical subject headings
Chronic Pain, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acceptance and Commitment Therapy (ACT)Behavioural

    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.

  • Cognitive Behavioral Therapy (CBT)Behavioural

    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.

Study groups in NCT07709572
Study groupRoleWhat they receive
ACT (Acceptance and Commitment Therapy)ExperimentalParticipants 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.
Receives: Behavioral: Acceptance and Commitment Therapy (ACT)
CBT (Cognitive Behavioral Therapy)Active comparatorParticipants 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.
Receives: Behavioral: Cognitive Behavioral Therapy (CBT)
TAU (Treatment as Usual)No interventionParticipants in this arm continue their routine medical/pharmacological care for chronic pain without receiving any structured psychological intervention as part of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and post-intervention (Week 10)

  2. 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.

    Measured: Baseline and post-intervention (Week 10)

  3. 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.

    Measured: Baseline and post-intervention (Week 10)

Secondary outcomes (5)
  1. Change in Pain Intensity

    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").

    Measured: Baseline and post-intervention (Week 10)

  2. Change in Pain Catastrophizing

    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.

    Measured: Baseline and post-intervention (Week 10)

  3. Change in Anxiety Symptoms

    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.

    Measured: Baseline and post-intervention (Week 10)

  4. Change in Depression Symptoms

    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.

    Measured: Baseline and post-intervention (Week 10)

  5. Change in Quality of Life

    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.

    Measured: Baseline and post-intervention (Week 10)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2026
  2. Study start13 May 2026
  3. Primary completion26 Jul 2026 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07709572
Sponsor's protocol ID
GIFT/PSY/MS/2025/002
Status last verified
Jul 2026
First submitted
12 Jul 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT) in people with Chronic Non-Malignant Pain (Chronic Musculoskeletal Pain, Chronic Widespread Pain), run by GIFT University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Acceptance (time frame: Baseline and post-intervention (Week 10)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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