Online Cognitive Behavioral Therapy (CBT) Workbook

Study Overview
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Brief Summary
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This research will evaluate the efficacy of a new online self- help intervention, the Wellness Workbook, for individuals with chronic low back pain (CLBP). Participants will be randomly assigned to use the Wellness Workbook or alternative self-help materials and assessed at baseline, post-intervention (10 weeks) and at follow-up (18 weeks). Outcome measures include pain-related disability and pain severity.

Detailed Description
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This research will evaluate the efficacy of a new online self- help intervention, the Wellness Workbook, for individuals with chronic low back pain (CLBP). The Wellness Workbook is an interactive online intervention that uses evidence-based cognitive behavioral therapy (CBT) strategies, behavioral activation and mindfulness training to increase chronic pain patients' quality of life. 198 patients with chronic low back pain will be randomly assigned to use the Wellness Workbook or alternative self-help materials for 10 weeks. Participants will be assessed at baseline, post-intervention (10 weeks) and at follow-up (18 weeks). Outcome measures include pain-related disability, pain severity, physical activity, mindfulness and pain-related attitudes and beliefs.

Official Title
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Wellness Workbook: Efficacy of an Online CBT Workbook for Chronic Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Wellness Workbook
* Other: Pain Management Print Materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: currently experiencing chronic non-cancer pain in the lower back Exclusion Criteria: has a health diagnosis that would prevent him/her from participating fully in the program (e.g., is receiving treatment for cancer) does not have regular Internet access

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Control Group participants will receive a well-regarded book for back pain patients. | Other: Pain Management Print Materials<br>* Print materials comparable to the content within Wellness Workbook<br>|
| Experimental: Wellnes Workbook<br>Participants will receive the Wellness Workbook, a web-based cognitive behavioral pain management intervention to help individuals with chronic low back pain (CLBP) learn adaptive coping and pain management skills, increase their physical activity and manage stress with relaxation and mindfulness training | Other: Wellness Workbook<br>* A web-based cognitive behavioral pain management intervention to help individuals with chronic low back pain (CLBP) learn adaptive coping and pain management skills, increase physical activity and manage stress. This is a 10 week intervention. Participants use one chapter of the workbook each week. Each chapter takes approximately 1.5 hours to complete.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower pain related disability and interference scores. | As compared to the control group participants, CLBP patients who use the WW intervention will report lower pain-related disability and lower pain interference scores. | Baseline, 10 weeks, 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fewer pain-related disabling beliefs and attitudes. | As compared to the control group participants, CLBP patients who use the WW will report fewer pain-related disabling beliefs and attitudes, have better self-efficacy for managing pain and negative affect and will score higher on mindfulness/present moment awareness. They will also have higher physical activity scores and lower depression scores. | Baseline, 10 weeks, 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive behavioral pain management, coping, mindfulness, physical activity, Back Pain Lower Back Chronic, Chronic low back pain