Online Cognitive Behavioral Therapy (CBT) Workbook (WW)

Talaria

Status and phase: Completed; Phase 2

Conditions: Low Back Pain

Treatments: Other: Wellness Workbook; Other: Pain Management Print Materials

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT01337843

AR052569

5R44AR052569-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

198 participants in 2 patient groups

Control Group

Active Comparator group

Description:

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

Treatment:

Other: Pain Management Print Materials

Wellnes Workbook

Experimental group

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

Treatment:

Other: Wellness Workbook