Chronic Non-Malignant Pain (Chronic Musculoskeletal Pain, Chronic Widespread Pain)
Conditions
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
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.
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.
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.
Sponsors
GIFT University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Acceptance | 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. |
| Change in Psychological Flexibility | 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. |
| Change in Pain Interference | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity | 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"). |
| Change in Pain Catastrophizing | 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. |
| Change in Anxiety Symptoms | 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. |
| Change in Depression Symptoms | 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. |
| Change in Quality of Life | 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. |
Countries
Pakistan
Contacts
STUDY_DIRECTORAther Mujitaba, Phd
GIFT University
Outcome results
None listed