Acceptance and Commitment Therapy With and Without Enhanced Mindfulness Training for Chronic Pain (MUST)

Acceptance and Commitment Therapy With and Without Enhanced Mindfulness Training for Chronic Pain: A Randomized Controlled Efficacy and Mediator Study

As non-pharmacological alternatives, psychosocial treatments have been recommended for chronic pain management. One such treatment is Acceptance and Commitment Therapy (ACT). ACT is a cognitive behavior therapy based on Relational Frame Theory, a comprehensive theory about language and cognition. This treatment intends to help patients identify values ("what is truly meaningful to them") and to set goals and take action according to their values. ACT has research support in the treatment of several mental health problems. Moreover patients are taught mindfulness skills to increase acceptance of pain, thoughts and feelings so that these will have less impact on functioning and action. Among patients with chronic pain, several small clinical trials have shown that ACT is more effective than other treatments in terms of increasing function and improving mental health. ACT in combination with mindfulness training has not been tested so far. Further methodologically robust trials are required. This study will therefore examine whether ACT is more effective for chronic pain than an education program, and whether adding daily mindfulness training will improve the outcome, in a large sample of patients from four multidisciplinary pain centers.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: ACT; Behavioral: mindfulness exercises and audio recordings; Behavioral: Education program

• Study Type: Interventional
• Enrollment (Actual): 667
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • Haukeland Universitetssykehus
  • Oslo, Norway
    • Oslo Universitetssykehus
  • Tromsø, Norway
    • Norges arktiske universitet
  • Trondheim, Norway
    • St Olavs hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• referred to one of the pain clinics in Oslo (200), Trondheim (200), Bergen (100) or Tromsø (100)
• primary diagnosis of chronic pain lasting for at least 6 months

Exclusion Criteria:

• severe somatic disease
• severe mental disorder (ongoing mania, psychosis, suicidal ideation, substance abuse/addiction
• not able to communicate in Norwegian
• needing 24-hour personal assistance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACT with mindfulness; 4-hour weekly session of acceptance and commitment therapy (ACT) with mindfulness exercises during 8 weeks in groups of 8	Behavioral: ACT; Acceptance and commitment therapy (ACT) sessions, lead by 2 qualified therapists, using a manual based on Steven Hayes et al 1999 that was adapted to group therapy and includes all the dynamic processes of ACT.; Behavioral: mindfulness exercises and audio recordings; mindfulness exercises introduced in the ACT sessions. In addition daily home meditation exercises based on the program developed by Kabat-Zinn 2005 and with help of audio recordings.
Experimental: ACT without mindfulness; 4-hour weekly acceptance and commitment therapy (ACT) without mindfulness exercises during 8 weeks in groups of 8	Behavioral: ACT; Acceptance and commitment therapy (ACT) sessions, lead by 2 qualified therapists, using a manual based on Steven Hayes et al 1999 that was adapted to group therapy and includes all the dynamic processes of ACT.
Active Comparator: Education program; Self-management education program during 8 weeks in groups of 8.	Behavioral: Education program; Self-management education program. Information given by a qualified health professional on pain and symptom management, stress, sleep, eating habits, mental health problems. Group discussions about thoughts and experiences. communication skills and physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity measured by the Norwegian Brief Pain Inventory (BPI)	the Brief Pain Inventory includes four 0-10 numerical rating scales: for 'pain now', and for 'least pain', 'worst pain', and 'average pain' during the last 24 hours, with 0 = no pain to 10 = pain as bad as you can imagine. A pain severity index is calculated by adding the scores on the pain severity items	44 weeks after end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity measured by the Norwegian Brief Pain Inventory (BPI)	the Brief Pain Inventory includes four 0-10 numerical rating scales: for 'pain now', and for 'least pain', 'worst pain', and 'average pain' during the last 24 hours, with 0 = no pain to 10 = pain as bad as you can imagine. A pain severity index is calculated by adding the scores on the pain severity items	8 weeks after end of treatment
pain intensity measured by the Norwegian Brief Pain Inventory (BPI)	the Brief Pain Inventory includes four 0-10 numerical rating scales: for 'pain now', and for 'least pain', 'worst pain', and 'average pain' during the last 24 hours, with 0 = no pain to 10 = pain as bad as you can imagine. A pain severity index is calculated by adding the scores on the pain severity items	24 weeks after end of treatment
pain intensity measured by the Norwegian Brief Pain Inventory (BPI)	the Brief Pain Inventory includes four 0-10 numerical rating scales: for 'pain now', and for 'least pain', 'worst pain', and 'average pain' during the last 24 hours, with 0 = no pain to 10 = pain as bad as you can imagine. A pain severity index is calculated by adding the scores on the pain severity items	3 years after end of treatment
physical function	according to the SF-36 Health Survey	8 weeks after end of treatment
physical function	according to the SF-36 Health Survey	24 weeks after end of treatment
physical function	according to the SF-36 Health Survey	44 weeks after end of treatment
physical function	according to the SF-36 Health Survey	3 years after end of treatment
mental health	according to the SF-36 Health Survey	8 weeks after end of treatment
mental health	according to the SF-36 Health Survey	24 weeks after end of treatment
mental health	according to the SF-36 Health Survey	44 weeks after end of treatment
mental health	according to the SF-36 Health Survey	3 years after end of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
attentional functioning	assessed by the Attention Network Test (Fan et al 2002) specifically designed to measure alerting, orienting and executive attention within a single testing session, which can be reported from the patients computer and lasts about 15 min	8 weeks after end of treatment
attentional functioning	assessed by the Attention Network Test (Fan et al 2002) specifically designed to measure alerting, orienting and executive attention within a single testing session, which can be reported from the patients computer and lasts about 15 min	24 weeks after end of treatment
attentional functioning	assessed by the Attention Network Test (Fan et al 2002) specifically designed to measure alerting, orienting and executive attention within a single testing session, which can be reported from the patients computer and lasts about 15 min	44 weeks after end of treatment

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Oslo University Hospital; University Hospital of North Norway; Norwegian University of Science and Technology; Haukeland University Hospital
• Investigators: Principal Investigator: Tormod Landmark, phd, St. Olavs Hospital

Publications and helpful links

General Publications

• Nost TH, Woodhouse A, Dale LO, Hara KW, Steinsbekk A. Participants' experiences from group-based treatment at multidisciplinary pain centres - a qualitative study. Scand J Pain. 2021 Aug 30;22(2):365-373. doi: 10.1515/sjpain-2021-0099. Print 2022 Apr 26.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2020
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Mindfulness; Behavior Therapy; Psychotherapy, Group
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2019/503

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No