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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mean Change in Anxiety |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisham Ashrafioun, PhD | VA Finger Lakes Healthcare System, Canandaigua, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Finger Lakes Healthcare System, Canandaigua, NY | Canandaigua | New York | 14424-1159 | United States |
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The first 8 participants all received CBT for Loneliness after a baseline assessments. For the next 40 participants, participants in both conditions receive a baseline assessment and then were randomized to either CBT for Chronic Pain or CBT for Loneliness.
Potential participants were recruited through a case finding procedure of VHA medical records.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Two participants in the CBT for Loneliness arm were consented, but did not complete the baseline assessment. The other participant withdrew.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | CBT for Chronic Pain |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participant flow includes participants from the one-arm trial. Participants reported in the outcomes do not include participants from the one-arm trial because there was not a one-month follow-up. | Posted | Mean | Standard Deviation | score on a scale | baseline to 1-month post-treatment |
|
from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital admission - COPD | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | unrelated to study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency department visit - pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | unrelated to study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisham Ashrafioun | VA Center of Excellence for Suicide Prevention | 585-430-2026 | Lisham.ashrafioun@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 22, 2023 | Nov 21, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 2, 2024 | Apr 2, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D012934 | Social Isolation |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants are randomized to one of two interventions.
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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.
| 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. |
|
| Mean Change in Fear of Pain | Fear of movement due to pain will be measured using the Tampa Scale of Kinesiophobia. The scores range from 17-68 with higher scores indicating worse outcome. | baseline to 1-month post-treatment |
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 |
| 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. Scores range from 0 to 52 with higher scores indicate greater pain catastrophizing. | baseline to 1-month post-treatment |
CBT delivered over the course of 8, ~45 minute sessions delivered via telehealth broadly focused on increasing quality of life despite being in pain.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| UCLA Loneliness Scale | The scores range from 20-80 with higher scores indicating worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Brief Pain Inventory-Pain Interference | Scores range from 0 to 70 with higher scores indicating worse outcomes. | Mean | Standard Deviation | units on a scale |
|
| Tampa Scale of Kinesiophobia | Scores range from 17 to 68 with higher scores indicating worse outcomes. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Depression | The scores range from 4-20 with higher scores indicating worse outcome. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Anxiety | The scores range from 4-20 with higher scores indicating worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Pain Catastrophizing Scale | Scores range from 0 to 52 with higher scores indicating worse outcomes. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
| 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) with scores ranging from 0 to 70. Higher scores represent greater pain-related interference in activity. | Participant flow includes participants from the one-arm trial. Participants reported in the outcomes do not include participants from the one-arm trial because there was not a one-month follow-up. | Posted | Mean | Standard Deviation | score of a scale | 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. | Participant flow includes participants from the one-arm trial. Participants reported in the outcomes do not include participants from the one-arm trial because there was not a one-month follow-up. | Posted | Mean | Standard Deviation | score on scale | baseline to 1-month post-treatment |
|
|
|
| Secondary | Mean Change in Fear of Pain | Fear of movement due to pain will be measured using the Tampa Scale of Kinesiophobia. The scores range from 17-68 with higher scores indicating worse outcome. | Participant flow includes participants from the one-arm trial. Participants reported in the outcomes do not include participants from the one-arm trial because there was not a one-month follow-up. | Posted | Mean | Standard Deviation | score on a scale | baseline to 1-month post-treatment |
|
|
|
| Other Pre-specified | Mean Change in Depression | Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome. | Participant flow includes participants from the one-arm trial. Participants reported in the outcomes do not include participants from the one-arm trial because there was not a one-month follow-up. | Posted | Mean | Standard Deviation | score on a scale | baseline to 1-month post-treatment |
|
|
|
| Other Pre-specified | Mean Change in Anxiety | Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome. | Participant flow includes participants from the one-arm trial. Participants reported in the outcomes do not include participants from the one-arm trial because there was not a one-month follow-up. | Posted | Mean | Standard Deviation | score on a scale | baseline to 1-month post-treatment |
|
|
|
| Other Pre-specified | 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. Scores range from 0 to 52 with higher scores indicate greater pain catastrophizing. | Participant flow includes participants from the one-arm trial. Participants reported in the outcomes do not include participants from the one-arm trial because there was not a one-month follow-up. | Posted | Mean | Standard Deviation | score on a scale | baseline to 1-month post-treatment |
|
|
|
| 0 |
| 28 |
| 3 |
| 28 |
| 7 |
| 28 |
| EG001 | 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. | 0 | 20 | 2 | 20 | 6 | 20 |
|
| Hospital admission - falls | Nervous system disorders | Non-systematic Assessment | unrelated to study |
|
| Hospital admission - Nerve pain | Nervous system disorders | Non-systematic Assessment |
|
| Hospital admission - suicidal ideation | Psychiatric disorders | Systematic Assessment | unrelated to study |
|
| Hospital admission - hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment | unrelated to study |
|
|
| Emergency department visit - head pain | Nervous system disorders | Non-systematic Assessment | unrelated to study |
|
| Emergency department visit - nausea, chest pain | Gastrointestinal disorders | Non-systematic Assessment | unrelated to study |
|
| Psychological distress | Social circumstances | Systematic Assessment | unrelated to study |
|
| Emergency department visit - pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | unrelated to study |
|
| Emergency department - fall | Nervous system disorders | Non-systematic Assessment | unrelated to study |
|
| Emergency department visit - erectile dysfunction | Reproductive system and breast disorders | Non-systematic Assessment | unrelated to study |
|
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| D012919 | Social Behavior |
| D001519 | Behavior |