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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

April 15, 2011
December 12, 2011
April 2011
April 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01337843 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Online Cognitive Behavioral Therapy (CBT) Workbook
Wellness Workbook: Efficacy of an Online CBT Workbook for Chronic Low Back Pain

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Low Back Pain
  • 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.
  • Other: Pain Management Print Materials
    Print materials comparable to the content within Wellness Workbook
  • Active Comparator: Control Group
    Control Group participants will receive a well-regarded book for back pain patients.
    Intervention: Other: Pain Management Print Materials
  • 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
    Intervention: Other: Wellness Workbook
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
198
July 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01337843
AR052569, 5R44AR052569-03
Yes
Kelly Carpenter Ph.D., Talaria Inc
Talaria, Inc
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Susan Stoner, Ph.D. Talaria, Inc
Talaria, Inc
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP