Chronic Pain
Conditions
Keywords
Mindfulness, Psychotherapy, Group, Behavior Therapy
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.
Interventions
BEHAVIORALACT
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.
BEHAVIORALmindfulness 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.
BEHAVIORALEducation 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
Sponsors
Norwegian University of Science and Technology
Oslo University Hospital
University Hospital of North Norway
Haukeland University Hospital
St. Olavs Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain intensity measured by the Norwegian Brief Pain Inventory (BPI) | 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
| Measure | Time frame | Description |
|---|---|---|
| pain intensity measured by the Norwegian Brief Pain Inventory (BPI) | 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 |
| physical function | 8 weeks after end of treatment | according to the SF-36 Health Survey |
| mental health | 8 weeks after end of treatment | according to the SF-36 Health Survey |
Other
| Measure | Time frame | Description |
|---|---|---|
| attentional functioning | 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 |
Countries
Norway
Outcome results
None listed