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

St. Olavs Hospital

Status: Completed

Conditions: Chronic Pain

Treatments: Behavioral: mindfulness exercises and audio recordings; Behavioral: Education program; Behavioral: ACT

Study type: Interventional

Funder types: Other

Identifiers

NCT04057144

2019/503

Details and patient eligibility

About

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.

Enrollment: 667 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

667 participants in 3 patient groups

ACT with mindfulness

Experimental group

Description:

4-hour weekly session of acceptance and commitment therapy (ACT) with mindfulness exercises during 8 weeks in groups of 8

Treatment:

Behavioral: ACT

Behavioral: mindfulness exercises and audio recordings

ACT without mindfulness

Experimental group

Description:

4-hour weekly acceptance and commitment therapy (ACT) without mindfulness exercises during 8 weeks in groups of 8

Treatment:

Behavioral: ACT

Education program

Active Comparator group

Description:

Self-management education program during 8 weeks in groups of 8.

Treatment:

Behavioral: Education program