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Completed

NCT Number: NCT01337843

Online Cognitive Behavioral Therapy (CBT) Workbook

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.

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Key information

Conditions

Low Back Pain Back Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Talaria Inc

Seattle, Washington, 98122, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wellness Workbook

Other

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.

Pain Management Print Materials

Other

Print materials comparable to the content within Wellness Workbook

Primary outcomes

  1. Lower pain related disability and interference scores.

    Time frame: 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 outcomes

  1. Fewer pain-related disabling beliefs and attitudes.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Talaria, Inc

Industry

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

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

Acronym: WW

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 19, 2011
Registry last updated
May 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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