Dual Treatment of Chronic Pain and Insomnia
1 other identifier
interventional
114
1 country
1
Brief Summary
This study is to evaluate a group-based cognitive behavioral therapy for insomnia (CBT-I) intervention delivered in an interdisciplinary pain rehabilitation program (IPRP) compared to usual care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2021
CompletedFirst Submitted
Initial submission to the registry
August 18, 2021
CompletedFirst Posted
Study publicly available on registry
September 2, 2021
CompletedSeptember 2, 2021
August 1, 2021
1.6 years
August 18, 2021
August 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Insomnia severity
Insomnia Severity Index (ISI), a 7-item self-report measure was administered to assess insomnia symptoms at up to 4 time points: 1) IPRP admission (both groups), 2) IPRP discharge (10 weeks later; both groups); 3) CBT-I intervention week 1 (IPRP+CBT-I group only) and CBT-I intervention week 4 (IPRP+CBT-I group only)
pre- and post-CBT-I intervention (group intervention weeks 1 and 4); pre- and post-IPRP intervention (IPRP weeks 0 and 10)
Secondary Outcomes (3)
Pain severity
pre- and post-IPRP intervention (weeks 0 and 10)
Pain interference
pre- and post-IPRP intervention (weeks 0 and 10)
Depressed mood
pre- and post-IPRP intervention (weeks 0 and 10)
Study Arms (2)
IPRP + CBT-I
EXPERIMENTALInterdisciplinary Pain Rehabilitation Program + Cognitive Behavioral Therapy for Insomnia (IPRP + CBT-I)
IPRP-UC
ACTIVE COMPARATORInterdisciplinary Pain Rehabilitation Program Usual Care (IPRP-UC)
Interventions
4-session CBT-I group in addition to IPRP
10-week IPRP usual care
Eligibility Criteria
You may qualify if:
- enrolled in the IPRP
- has chronic pain
- Insomnia Severity Index (ISI) score of 8 or greater
- English-speaking
- able to provide informed consent
- years of age or older
You may not qualify if:
- non-English-speaking
- unable to provide informed consent
- less than 18 years of age
- ISI score less than 8
- not concurrently enrolled in the IPRP
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mary Free Bed Rehabilitation Hospital
Grand Rapids, Michigan, 49503, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Psychologist
Study Record Dates
First Submitted
August 18, 2021
First Posted
September 2, 2021
Study Start
June 6, 2019
Primary Completion
January 28, 2021
Study Completion
April 27, 2021
Last Updated
September 2, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share