Physical Activity and Acceptance and Commitment Therapy as Treatment for Long Term Pain

Study Overview
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Brief Summary
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Only to a limited extent has been compared the effectiveness of physical exercise and psychological interventions in subjects with chronic pain. Knowledge about this is necessary in order to compose optimal multimodal rehabilitation programs at different health care levels. Moreover, assuming that both types of interventions have effects, these effects may necessarily not concern the same outcome variables. Therefore it may be important to understand to what extent the effects overlap and the extent to which the effects are isolated to an intervention. The overall strategic purpose of the present study is to develop effective multimodal rehabilitation programs. In this study the effectiveness of following three interventions are compared. Group-based rehabilitation according to a concept based on an Acceptance and Commitment Training -Stress Management Intervention (ACT-SMI) Group-based rehabilitation compromised of physical exercise (Exercise). Group-based discussion concerning pain and its consequences (i.e., the control group, CON) The effectiveness is investigated with respect to long-term effects on pain and its consequences, including perceived health and return to work / sick leave. The overall hypothesis is that the former intervention means better long-term results because it clearly helps the individual to process the psychological aspects of itself likely to have long lasting effects.

Official Title
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Physical Activity and Acceptance and Commitment Therapy as Treatment for Long Term Pain. A Randomized Controlled Trial

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: ACT
* Other: Physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic pain in the neck and/or back with or without pain in one or more quadrants of the body Exclusion Criteria: Inflammatory and neurological diseases, severe social and/or psychological problems, patients that already have taken part in multidisciplinary rehabilitation programs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT<br>Acceptance and Commitment Therapy is a version of Cognitive behavioral Therapy that focuses on acceptance and mindfulness. The aim is to prevent avoidance and control of negative private events such as anxiety or pain. The treatment consists of 7 weekly group sessions, 2 hours a week. The participants are given homework between sessions. | Behavioral: ACT<br>* ACT is a type of Cognitive behavioral Therapy (CBT) that focuses on acceptance and mindfulness. The aim is to prevent avoidance and control of negative private events such as anxiety or pain. The treatment consists of 7 weekly group sessions, 2 hours a week. The participants are given homework between sessions.<br>|
| Experimental: Physical activity<br>Participants are going to participate in a training programme including aerobic exercise as well as endurance and strength training for the neck, shoulders, low back, core and leg muscles. The training is group-based and supervised by a physiotherapist two times a week, one hour a time for eight weeks. Home exercises twice a week are also a part of the intervention. It is possible to individually adjust movements and intensity to the participants' capacity if needed. | Other: Physical activity<br>* Participants are going to perform a training programme including aerobic exercise as well as endurance and strength training for the neck, shoulders, low back, core and leg muscles. The training is group-based and supervised by a physiotherapist two times a week, one hour a time for eight weeks. Home exercises twice a week are also a part of the intervention. It is possible to individually adjust movements and intensity to the participants' capacity if needed.<br>|
| No Intervention: Experience based discussion group<br>Participants are going to discuss their experiences of long term pain. The discussions is supervised by a heath care professional and is based on beforehand defined subjects, i.e. relations, spare time, economics, occupation. The meetings are hold for 7 weeks, 2 hours a week. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain intensity | Pain intensity recent 7 days using a numeric rating scale | Change from baseline pain intensity at 12 months | 
| Change in Depression | Depression scale of Hospital Anxiety and Depression Scale (HADS) | Change from baseline depression at 12 months | 
| Change in Catastrophizing | The Pain Catastrophizing Scale (PCS) | Change from baseline catastrophizing at 12 months | 
| Change in Acceptance | The Chronic Pain Acceptance Questionnaire (CPAQ) | Change from baseline acceptance at 12 months | 
| Change in Disability | Pain Disability Index (PDI) | Change from baseline disability at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Flexibility | The Psychological Inflexibility in Pain Scale (PIPS) | Change from baseline flexibility at 12 months | 
| Change in Insomnia | The Insomnia Severity Index (ISI) | Change from baseline insomnia at 12 months | 
| Change in Fear-avoidance beliefs | Fear-Avoidance Beliefs Questionnaire (FABQ) | Change from baseline fear-avoidance at 12 months | 
| Change in Disability2 | Oswestry Disability Index (ODI) | Change from baseline disability2 at 12 months | 
| Change in Health | The EuroQol instrument | Change from baseline health at 12 months | 
| Change in Life satisfaction | The Life Satisfaction Questionnaire. | Change from baseline life satisfaction at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, rehabilitation, exercise, psychological, intervention