N/A
N=48
Pain and Loneliness
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT05455476 ↗Enrolled (actual)
48
Serious AEs
10.4%
Results posted
Dec 2025
Primary outcome: Primary: Mean Change in Loneliness — -6.6; -2.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CBT for Loneliness (Behavioral); CBT for Chronic Pain (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Loneliness |
-6.6; -2.5 | — |
| PRIMARY Mean Change in Pain Interference |
-2.4; -0.5 | — |
| SECONDARY Mean Change in Social Interactions |
-0.33; 0.46 | — |
| SECONDARY Mean Change in Fear of Pain |
-3.17; -0.54 | — |
Summary
Loneliness-feeling socially isolated-is a stressor that is associated with chronic pain. The investigators will first conduct a small trial of Cognitive Behavioral Therapy for Loneliness (CBT-L)in Veterans with chronic pain reporting loneliness. After completing this small trial, the investigators will randomize-like a flip of a coin-a total of 40 participants to receive either CBT-L or CBT for Chronic Pain. The investigators will assess loneliness, the quality and quantity of social interactions, and pain outcomes such as pain-related interference, and thinking the worst about one's pain at baseline and after the treatment period. The investigators will also track participant flow, therapist adherence to the manual, participant homework completion, and participant satisfaction with the treatment.
Eligibility Criteria
Inclusion Criteria
- Are English-speaking
- Are 18 years of age or older
- Have access to a phone or computer
- Report pain that occurs on at least half the days for six months or more
- Score at least 4 (of 10) on each of the three items on the PEG (Pain intensity, and Pain interference in Enjoying activities and General activities)
- Screen positive for loneliness by scoring at least a T-score > 60 on the NIH Toolbox loneliness scale
Exclusion Criteria
- Do not understand informed consent
- Had a recent or have an upcoming surgery
- Have significant unstable or uncontrolled medical conditions, including cancer requiring ongoing oncology treatment
- Active severe substance use disorder
Data sourced from ClinicalTrials.gov (NCT05455476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.