Pain and Loneliness

NCT ID: NCT05455476

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-11-30

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.

Detailed Description

Loneliness-a subjective emotional state characterized by the perception of social isolation-is a psychosocial stressor that is associated with increased mortality and chronic pain. Individuals who have chronic pain and report loneliness experience greater pain-related interference in activities, depression, and suicidal ideation. Importantly, there are potentially effective interventions that can be used to decrease loneliness; however, there are no studies that have directly intervened on loneliness among Veterans with chronic pain. Cognitive-Behavioral Therapy for Loneliness (CBT-L) intervenes on loneliness by addressing negative beliefs that perpetuate loneliness, increase negative affect, and reduce one's ability to engage in social activities. For a Veteran with chronic pain, this is critical as addressing negative affect, and having a sense that one has social support and engages social support are key aspects of increasing functioning. While CBT for Chronic Pain (CBT-CP) comprises skills to promote social functioning, more robust efforts may be needed to better address lonely while also addressing functional impairment.

The proposed two-year study uses a novel application of a brief, phone-delivered, evidence-based intervention, CBT-L, to decrease loneliness by modifying socially-relevant maladaptive thinking patterns, increasing engagement in enjoyable and social activities, and improving problem solving skills. Participants will be recruited nationally using online advertising. The objectives of the current proposal are to adapt CBT-L to optimize its impact on Veterans with chronic pain, examine if the recruitment, retention, and treatment delivery is feasible and if CBT-L is acceptable to participants, and assess parameters of key outcomes among participants randomized to receive CBT-L versus CBT-CP to inform a subsequent larger clinical trial.

To achieve these objectives, the investigators will adapt a manual through an evidence-based, iterative process then conduct one-arm trial of CBT-L (n=8) in Veterans with chronic pain reporting loneliness. After refining the manual and procedures following the one-arm trial, the investigators will randomize a total of 40 participants to receive either CBT-L or CBT-CP. The investigators will assess loneliness, the quality and quantity of social interactions, and pain outcomes such as pain-related interference, and pain catastrophizing 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CBT for Loneliness

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

Group Type: EXPERIMENTAL

CBT for Loneliness

Intervention Type: 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 Chronic Pain

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

Group Type: ACTIVE_COMPARATOR

CBT for Chronic Pain

Intervention Type: 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.

Interventions

CBT for Loneliness

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

Intervention Type: BEHAVIORAL

CBT for Chronic Pain

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisham Ashrafioun, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Finger Lakes Healthcare System, Canandaigua, NY

Locations

VA Finger Lakes Healthcare System, Canandaigua, NY

Canandaigua, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

D4091-P

Identifier Type: -

Identifier Source: org_study_id