Online Cognitive Behavioral Therapy (CBT) Workbook

Phase 2

Completed

• Conditions: Low Back Pain
• Interventions: Other: Pain Management Print Materials; Other: Wellness Workbook

• Registration Number: NCT01337843
• Lead Sponsor: Talaria, Inc

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-04-18
• Study First Posted: 2011-04-19
• Primary Completion: 2013-04
• Study Completion: 2013-07
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-05
• Last Update Posted: 2014-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Pain Management Print Materials	Control Group participants will receive a well-regarded book for back pain patients.
Wellnes Workbook	Wellness Workbook	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

Primary Outcome Measures

Name	Time	Method
Lower pain related disability and interference scores.	Baseline, 10 weeks, 18 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Fewer pain-related disabling beliefs and attitudes.	Baseline, 10 weeks, 18 weeks	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.

Trial Locations

Locations (1)

Talaria Inc; 🇺🇸 Seattle, Washington, United States