Online Cognitive Behavioral Therapy (CBT) Workbook

NCT01337843 | Completed Phase 2 DMC

• 2 other identifiers: AR0525695R44AR052569-03
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain

Keywords

Chronic low back pain; cognitive behavioral pain management; coping; mindfulness; physical activity; Back Pain Lower Back Chronic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Fewer pain-related disabling beliefs and attitudes.

  Baseline, 10 weeks, 18 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Control Group participants will receive a well-regarded book for back pain patients.

Other: Pain Management Print Materials

Wellnes Workbook

EXPERIMENTAL

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

Interventions

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.

Wellnes Workbook

Pain Management Print Materials OTHER

Print materials comparable to the content within Wellness Workbook

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• currently experiencing chronic non-cancer pain in the lower back

You may not qualify if:

• 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

Sponsors & Collaborators

• Talaria, Inc: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Talaria Inc

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Susan Stoner, Ph.D.

  Talaria, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 19, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 7, 2014

Record last verified: 2014-05

Locations

US (1)