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Pain and Loneliness

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CBT for Loneliness
CBT for Chronic Pain
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Loneliness, Chronic pain, social isolation, social connection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Canandaigua VA Medical Center, Canandaigua, NYRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT for Loneliness

CBT for Chronic Pain

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 7, 2022
Last Updated
April 5, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05455476
Brief Title
Pain and Loneliness
Official Title
Telehealth CBT to Address Social Isolation in Veterans With Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Loneliness, Chronic pain, social isolation, social connection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized to one of two interventions.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT for Loneliness
Arm Type
Experimental
Arm Description
CBT delivered over the course of 8, ~45 minute sessions delivered via telehealth more centrally focused addressing factors contributing to loneliness and social isolation.
Arm Title
CBT for Chronic Pain
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
CBT for Loneliness
Intervention Description
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
Intervention Name(s)
CBT for Chronic Pain
Intervention Description
CBT delivered over the course of 8, ~45 minute sessions delivered via telehealth broadly focused on increasing quality of life despite being in pain.
Primary Outcome Measure Information:
Title
Mean change in loneliness
Description
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.
Time Frame
baseline to 1-month post-treatment
Title
Mean change in pain interference
Description
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.
Time Frame
baseline to 1-month post-treatment
Secondary Outcome Measure Information:
Title
Mean change in social interactions
Description
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.
Time Frame
baseline to 1-month post-treatment
Title
Mean change in fear of pain
Description
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.
Time Frame
baseline to 1-month post-treatment
Other Pre-specified Outcome Measures:
Title
Mean change in depression
Description
Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
Time Frame
baseline to 1-month post-treatment
Title
Mean change in anxiety
Description
Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
Time Frame
baseline to 1-month post-treatment
Title
Mean change in pain catastrophizing
Description
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.
Time Frame
baseline to 1-month post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisham Ashrafioun, PhD
Phone
(585) 393-7722
Email
lisham.ashrafioun@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisham Ashrafioun, PhD
Organizational Affiliation
Canandaigua VA Medical Center, Canandaigua, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Canandaigua VA Medical Center, Canandaigua, NY
City
Canandaigua
State/Province
New York
ZIP/Postal Code
14424-1159
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisham Ashrafioun, PhD
Phone
585-393-7722
Email
lisham.ashrafioun@va.gov
First Name & Middle Initial & Last Name & Degree
Lisham Ashrafioun, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Pain and Loneliness

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