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Online Cognitive Behavioral Therapy (CBT) Workbook (WW)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:
Talaria, Inc
ClinicalTrials.gov Identifier:
NCT01337843
First received: April 15, 2011
Last updated: December 12, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Low Back Pain
 Other: Wellness Workbook
Other: Pain Management Print Materials
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Wellness Workbook: Efficacy of an Online CBT Workbook for Chronic Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by Talaria, Inc:

Primary Outcome Measures:
  • Lower pain related disability and interference scores. [ Time Frame: Baseline, 10 weeks, 18 weeks ] [ Designated as safety issue: No ]
    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:
  • Fewer pain-related disabling beliefs and attitudes. [ Time Frame: Baseline, 10 weeks, 18 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 198
Study Start Date: April 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Group
Control Group participants will receive a well-regarded book for back pain patients.
 Other: Pain Management Print Materials
Print materials comparable to the content within Wellness Workbook
Experimental: Wellnes 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
 Other: 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 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337843

Locations
United States, Washington
Talaria Inc
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Talaria, Inc
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Susan Stoner, Ph.D. Talaria, Inc
  More Information

No publications provided

Responsible Party: Kelly Carpenter Ph.D., Talaria Inc
ClinicalTrials.gov Identifier: NCT01337843     History of Changes
Other Study ID Numbers: AR052569, 5R44AR052569-03
Study First Received: April 15, 2011
Last Updated: December 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Talaria, Inc:
Chronic low back pain
cognitive behavioral pain management
coping
 mindfulness
physical activity
Back Pain Lower Back Chronic

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013