Online Cognitive Behavioral Therapy (CBT) Workbook

Low Back Pain Clinical Trial

— WW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01337843
• Other study ID #: AR052569
• Secondary ID: 5R44AR052569-03
• Status: Completed
• Phase: Phase 2
• First received: April 15, 2011
• Last updated: May 5, 2014
• Start date: April 2011
• Est. completion date: July 2013

Study information

• Verified date: May 2014
• Source: Talaria, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: July 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• Pain Management Print Materials
Print materials comparable to the content within Wellness Workbook

Locations

Country	Name	City	State
United States	Talaria Inc	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Talaria, Inc	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower pain related disability and interference scores.	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.	Baseline, 10 weeks, 18 weeks	No
Secondary	Fewer pain-related disabling beliefs and attitudes.	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.	Baseline, 10 weeks, 18 weeks	No