Clinical trial NCT04057144: Acceptance and Commitment Therapy with and Without Enhanced Mindfulness Training for Chronic Pain
Official title: Acceptance and Commitment Therapy with and Without Enhanced Mindfulness Training for Chronic Pain: a Randomized Controlled Efficacy and Mediator Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Mindfulness
Psychotherapy, Group
Behavior Therapy
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: Oslo University Hospital
name: University Hospital of North Norway
name: Haukeland University Hospital
First posted: 2019-08-15
Enrollment: 667
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a three group randomized controlled trial with 162 patient in each group, six different measurement points, of which pre-treatment and 52 weeks after start of the treatment are the crucial points.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: pain intensity measured by the Norwegian Brief Pain Inventory (BPI)
timeFrame: 44 weeks after end of treatment
Secondary outcomes:
measure: pain intensity measured by the Norwegian Brief Pain Inventory (BPI)
timeFrame: 8 weeks after end of treatment
measure: pain intensity measured by the Norwegian Brief Pain Inventory (BPI)
timeFrame: 24 weeks after end of treatment
measure: pain intensity measured by the Norwegian Brief Pain Inventory (BPI)
timeFrame: 3 years after end of treatment
measure: physical function
timeFrame: 8 weeks after end of treatment
measure: physical function
timeFrame: 24 weeks after end of treatment
measure: physical function
timeFrame: 44 weeks after end of treatment
measure: physical function
timeFrame: 3 years after end of treatment
measure: mental health
timeFrame: 8 weeks after end of treatment
measure: mental health
timeFrame: 24 weeks after end of treatment
measure: mental health
timeFrame: 44 weeks after end of treatment
measure: mental health
timeFrame: 3 years after end of treatment
Other outcomes:
measure: attentional functioning
timeFrame: 8 weeks after end of treatment
measure: attentional functioning
timeFrame: 24 weeks after end of treatment
measure: attentional functioning
timeFrame: 44 weeks after end of treatment
Locations:
city: Bergen
country: Norway
facility: Haukeland universitetssykehus
city: Oslo
country: Norway
facility: Oslo universitetssykehus
city: Tromsø
country: Norway
facility: Norges arktiske universitet
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Tormod Landmark, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.