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NCT Number: NCT04057144

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

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland universitetssykehus, Bergen, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACT

Behavioral

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.

mindfulness exercises and audio recordings

Behavioral

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.

Education program

Behavioral

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

Primary outcomes

  1. pain intensity measured by the Norwegian Brief Pain Inventory (BPI)

    Time frame: 44 weeks after end of treatment

    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

Secondary outcomes

  1. pain intensity measured by the Norwegian Brief Pain Inventory (BPI)

    Time frame: 8 weeks after end of treatment

    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

  2. pain intensity measured by the Norwegian Brief Pain Inventory (BPI)

    Time frame: 24 weeks after end of treatment

    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. pain intensity measured by the Norwegian Brief Pain Inventory (BPI)

    Time frame: 3 years after end of treatment

    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

  4. physical function

    Time frame: 8 weeks after end of treatment

    according to the SF-36 Health Survey

  5. physical function

    Time frame: 24 weeks after end of treatment

    according to the SF-36 Health Survey

  6. physical function

    Time frame: 44 weeks after end of treatment

    according to the SF-36 Health Survey

  7. physical function

    Time frame: 3 years after end of treatment

    according to the SF-36 Health Survey

  8. mental health

    Time frame: 8 weeks after end of treatment

    according to the SF-36 Health Survey

  9. mental health

    Time frame: 24 weeks after end of treatment

    according to the SF-36 Health Survey

  10. mental health

    Time frame: 44 weeks after end of treatment

    according to the SF-36 Health Survey

  11. mental health

    Time frame: 3 years after end of treatment

    according to the SF-36 Health Survey

Other outcomes

  1. attentional functioning

    Time frame: 8 weeks after end of treatment

    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

  2. attentional functioning

    Time frame: 24 weeks after end of treatment

    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

  3. attentional functioning

    Time frame: 44 weeks after end of treatment

    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

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Haukeland University Hospital
  • Norwegian University of Science and Technology
  • Oslo University Hospital
  • University Hospital of North Norway

Registry information

Official study title

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

Acronym: MUST

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2019
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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