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Online Cognitive Behavioral Therapy (CBT) Workbook (WW)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01337843
First Posted: April 19, 2011
Last Update Posted: May 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Talaria, Inc
April 15, 2011
April 19, 2011
May 7, 2014
April 2011
April 2013   (Final data collection date for primary outcome measure)
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.
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 ]
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
Intervention Model: Parallel Assignment
Masking: None (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.
 
Completed
198
July 2013
April 2013   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01337843
AR052569
5R44AR052569-03 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Talaria, Inc
Talaria, Inc
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Susan Stoner, Ph.D. Talaria, Inc
Talaria, Inc
May 2014

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