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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
| Oslo University Hospital | OTHER |
| University Hospital of North Norway | OTHER |
| Haukeland University Hospital |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT with mindfulness | Experimental | 4-hour weekly session of acceptance and commitment therapy (ACT) with mindfulness exercises during 8 weeks in groups of 8 |
|
| ACT without mindfulness | Experimental | 4-hour weekly acceptance and commitment therapy (ACT) without mindfulness exercises during 8 weeks in groups of 8 |
|
| Education program | Active Comparator | Self-management education program during 8 weeks in groups of 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tormod Landmark, phd | St. Olavs Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland universitetssykehus | Bergen | Norway | ||||
| Oslo universitetssykehus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34453878 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 15, 2018 | Jun 17, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 16, 2024 | Nov 1, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000087983 | Sound Recordings |
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
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| OTHER |
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.
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| 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 |
|
| 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 |
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 |
| Oslo |
| Norway |
| Norges arktiske universitet | Tromsø | Norway |
| St Olavs Hospital | Trondheim | Norway |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |