ClinicalTrials.gg
Active, not recruitingNCT07709572Updated Jul 16, 2026

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

An interventional study of Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT) in Chronic Non-Malignant Pain (Chronic Musculoskeletal Pain, Chronic Widespread Pain), sponsored by GIFT University. Active, not recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by GIFT University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as active, not recruiting.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 18 studies in Chronic Pain with a site in Pakistan — 7 open to participants now, 9 under way, none of them phase 3. Chronic Pain · Pakistan.

Enrollment
7th of 17
60 · median 44
Started
2026
with 2 others
No phase
17 of 18
7 open now
Registered
18th of 18
by date
Lead sponsor
1 of 18
GIFT University

Among the 18 studies in Chronic Pain with a site in Pakistan, this one is the 7th largest by enrollment of the 17 interventional ones that give a count, is one of 3 that started in 2026, is one of 17 with no phase, and was the 18th registered.

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 728 are open to participants now.

Browse Chronic Pain studies →

Open to participants now

7 of the 18 studies in Chronic Pain with a site in Pakistan are open now. Recruiting first, the newest first:

2 more — sign in →

All 7 open studies →

A study can be open while its sites in Pakistan have not opened yet or have stopped. Only those recruiting at a site in Pakistan →

Who these studies take

Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 18 studies in Chronic Pain with a site in Pakistan, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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.

    Behavioral: Acceptance and Commitment Therapy (ACT)

  • Active comparator
    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.

    Behavioral: Cognitive Behavioral Therapy (CBT)

  • No intervention
    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.

Interventions

  • BehavioralAcceptance and Commitment Therapy (ACT)

    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.

  • BehavioralCognitive Behavioral Therapy (CBT)

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline and post-intervention (Week 10)

Secondary outcomes

  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").

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline and post-intervention (Week 10)

07

Study locations

1 site
  • DHQ Hospital, Gujranwala (Orthopedic Department)
    Guiranwala, Punjab Province 52250, Pakistan
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Jul 2026, 2 months after the start.

Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 2 months is below that.

Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 12, 2026
First posted
Jul 16, 2026
StartActual
May 13, 2026
Primary completionEst.
Jul 26, 2026
CompletionEst.
Jul 31, 2026
Last update
Jul 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07709572
Lead sponsor
GIFT University
Responsible party
Ambreen Ishaq (Principal Investigator, GIFT University) — Principal investigator
First posted
Jul 16, 2026
Start date
May 13, 2026
Primary completion
Jul 26, 2026 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Jul 16, 2026

Study contacts

Ather Mujitaba, Phd
study director · GIFT University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion