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Online Cognitive Behavioral Therapy (CBT) Workbook

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01337843
Acronym
WW
Enrollment
198
Registered
2011-04-19
Start date
2011-04-30
Completion date
2013-07-31
Last updated
2014-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

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

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.

Interventions

OTHERWellness 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.

OTHERPain Management Print Materials

Print materials comparable to the content within Wellness Workbook

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
Talaria, Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Lower pain related disability and interference scores.Baseline, 10 weeks, 18 weeksAs 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

MeasureTime frameDescription
Fewer pain-related disabling beliefs and attitudes.Baseline, 10 weeks, 18 weeksAs 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026