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Online Cognitive Behavioral Therapy (CBT) Workbook (WW)

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Wellness Workbook
Pain Management Print Materials
Sponsored by
Talaria, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Low Back Pain focused on measuring Chronic low back pain, cognitive behavioral pain management, coping, mindfulness, physical activity, Back Pain Lower Back Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Talaria Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Wellnes Workbook

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 15, 2011
Last Updated
May 5, 2014
Sponsor
Talaria, Inc
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT01337843
Brief Title
Online Cognitive Behavioral Therapy (CBT) Workbook
Acronym
WW
Official Title
Wellness Workbook: Efficacy of an Online CBT Workbook for Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Talaria, Inc
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Chronic low back pain, cognitive behavioral pain management, coping, mindfulness, physical activity, Back Pain Lower Back Chronic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Control Group participants will receive a well-regarded book for back pain patients.
Arm Title
Wellnes Workbook
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Wellness Workbook
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pain Management Print Materials
Intervention Description
Print materials comparable to the content within Wellness Workbook
Primary Outcome Measure Information:
Title
Lower pain related disability and interference scores.
Description
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.
Time Frame
Baseline, 10 weeks, 18 weeks
Secondary Outcome Measure Information:
Title
Fewer pain-related disabling beliefs and attitudes.
Description
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.
Time Frame
Baseline, 10 weeks, 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Stoner, Ph.D.
Organizational Affiliation
Talaria, Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Talaria Inc
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Online Cognitive Behavioral Therapy (CBT) Workbook

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