Pain and Loneliness

NCT05455476 | Completed Results

• 1 other identifier: D4091-P
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain

Keywords

Loneliness; Chronic pain; social isolation; social connection

Outcome Measures

Primary Outcomes (2)

• Mean Change in Loneliness

  Loneliness will be measured using the UCLA Loneliness Scale. A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as 1 (never), 2 (rarely), 3 (sometimes) or 4 (often). The scores range from 20-80 with higher scores indicating worse outcome.

  baseline to 1-month post-treatment

• Mean Change in Pain Interference

  Pain interference will be measured using the Brief Pain Inventory Pain Interference subscale. The pain interference subscale comprises 7 items assessing the extent to which pain interferes with various aspects of one's life (e.g., mood, sleep, daily activities) with scores ranging from 0 to 70. Higher scores represent greater pain-related interference in activity.

  baseline to 1-month post-treatment

Secondary Outcomes (2)

• Mean Change in Social Interactions

  baseline to 1-month post-treatment

• Mean Change in Fear of Pain

  baseline to 1-month post-treatment

Other Outcomes (3)

• Mean Change in Depression

  baseline to 1-month post-treatment

• Mean Change in Anxiety

  baseline to 1-month post-treatment

• Mean Change in Pain Catastrophizing

  baseline to 1-month post-treatment

Study Arms (2)

CBT for Loneliness

EXPERIMENTAL

CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth more centrally focused addressing factors contributing to loneliness and social isolation.

Behavioral: CBT for Loneliness

CBT for Chronic Pain

ACTIVE COMPARATOR

CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth broadly focused on increasing quality of life despite being in pain.

Behavioral: CBT for Chronic Pain

Interventions

CBT for Loneliness BEHAVIORAL

CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth more centrally focused addressing factors contributing to loneliness and social isolation.

CBT for Loneliness

CBT for Chronic Pain BEHAVIORAL

CBT delivered over the course of 8, \~45 minute sessions delivered via telehealth broadly focused on increasing quality of life despite being in pain.

CBT for Chronic Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Finger Lakes Healthcare System, Canandaigua, NY

Canandaigua, New York, 14424-1159, United States

Location

MeSH Terms

Conditions

Chronic Pain; Social Isolation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Results Point of Contact

• Title: Lisham Ashrafioun
• Organization: VA Center of Excellence for Suicide Prevention

Lisham.ashrafioun@va.gov

585-430-2026

Study Officials

• Lisham Ashrafioun, PhD

  VA Finger Lakes Healthcare System, Canandaigua, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors will not know what condition that the participant was allocated to, nor will the statistician who is one of the co-investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants are randomized to one of two interventions.

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 13, 2022
• Study Start: April 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 18, 2025
• Results First Posted: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)