Online Cognitive Behavioral Therapy (CBT) Workbook

NCT ID: NCT01337843

Last Updated: 2014-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-07-31

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control Group

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

Group Type ACTIVE_COMPARATOR

Pain Management Print Materials

Intervention Type OTHER

Print materials comparable to the content within Wellness Workbook

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

Group Type EXPERIMENTAL

Wellness Workbook

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Pain Management Print Materials

Print materials comparable to the content within Wellness Workbook

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

Talaria, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Stoner, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Talaria, Inc

Locations

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Talaria Inc

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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5R44AR052569-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AR052569

Identifier Type: -

Identifier Source: org_study_id

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