Pain and Loneliness

Chronic Pain Clinical Trial

Official title:

Telehealth CBT to Address Social Isolation in Veterans With Chronic Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05455476
• Other study ID #: D4091-P
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 loneness 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	VA Finger Lakes Healthcare System, Canandaigua, NY	Canandaigua	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean change in depression	Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.	baseline to 1-month post-treatment
Other	Mean change in anxiety	Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.	baseline to 1-month post-treatment
Other	Mean change in pain catastrophizing	The Pain Catastrophizing Scale (PCS) is a 13-item measure, with each item rated on a 5-point rating scale (0 = "Not at all" to 4 = "All the time"). The measure is divided into three subscales: magnification, rumination, and helplessness. Higher scores indicate greater pain catastrophizing.	baseline to 1-month post-treatment
Primary	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
Primary	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). Higher scores represent greater pain-related interference in activity.	baseline to 1-month post-treatment
Secondary	Mean change in social interactions	Duke Social Support Index assesses several domains of perceived social support, including social network size, social interaction, social satisfaction, and instrumental social support. Higher scores indicate a higher quality of social interactions. Scores range from 0 to 37.	baseline to 1-month post-treatment
Secondary	Mean change in fear of pain	The Tampa Scale of Kinesiophobia-11 (TSK) is an 11-item measure assessing pain-related fear of movement or injury. The rating scale ranges from 1 to 4 with high scores indicating greater fear of movement.	baseline to 1-month post-treatment