Pain and Loneliness

Telehealth CBT to Address Social Isolation in Veterans With Chronic Pain

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05455476

Enrollment

Registered

2022-07-13

Start date

2023-04-01

Completion date

2024-11-30

Last updated

2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Loneliness, Chronic pain, social isolation, social connection

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.

Interventions

BEHAVIORALCBT 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.

BEHAVIORALCBT 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes 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.

Intervention model description

Participants are randomized to one of two interventions.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Mean Change in Loneliness	baseline to 1-month post-treatment	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	baseline to 1-month post-treatment	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.

Secondary

Measure	Time frame	Description
Mean Change in Social Interactions	baseline to 1-month post-treatment	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	baseline to 1-month post-treatment	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.

Other

Measure	Time frame	Description
Mean Change in Anxiety	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.
Mean Change in Pain Catastrophizing	baseline to 1-month post-treatment	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.
Mean Change in Depression	baseline to 1-month post-treatment	Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.

Countries

United States

Participant flow

Recruitment details

Potential participants were recruited through a case finding procedure of VHA medical records.

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	25
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.	20
Total	45

Baseline characteristics

Characteristic	Total	CBT for Chronic Pain	CBT for Loneliness
Age, Continuous	53.8 Years STANDARD_DEVIATION 12.2	52.8 Years STANDARD_DEVIATION 14.3	54.6 Years STANDARD_DEVIATION 10.7
Brief Pain Inventory-Pain Interference	53.8 units on a scale STANDARD_DEVIATION 11.3	55.4 units on a scale STANDARD_DEVIATION 8.9	52.5 units on a scale STANDARD_DEVIATION 13.2
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	0 Participants	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants	20 Participants	21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	1 Participants
Pain Catastrophizing Scale	31.2 units on a scale STANDARD_DEVIATION 10.3	30.2 units on a scale STANDARD_DEVIATION 9	31.9 units on a scale STANDARD_DEVIATION 11.5
PROMIS Anxiety	11.8 units on a scale STANDARD_DEVIATION 3.7	13.0 units on a scale STANDARD_DEVIATION 3	10.9 units on a scale STANDARD_DEVIATION 4.1
PROMIS Depression	11.8 units on a scale STANDARD_DEVIATION 4.1	13.1 units on a scale STANDARD_DEVIATION 3.6	10.8 units on a scale STANDARD_DEVIATION 4.3
Race (NIH/OMB) American Indian or Alaska Native	3 Participants	2 Participants	1 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	11 Participants	5 Participants	6 Participants
Race (NIH/OMB) More than one race	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) White	27 Participants	11 Participants	16 Participants
Sex: Female, Male Female	9 Participants	4 Participants	5 Participants
Sex: Female, Male Male	36 Participants	16 Participants	20 Participants
Tampa Scale of Kinesiophobia	46.0 units on a scale STANDARD_DEVIATION 7.7	46.3 units on a scale STANDARD_DEVIATION 7.9	45.8 units on a scale STANDARD_DEVIATION 7.9
UCLA Loneliness Scale	56.4 units on a scale STANDARD_DEVIATION 10.2	56.8 units on a scale STANDARD_DEVIATION 10.3	56.0 units on a scale STANDARD_DEVIATION 10.4

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 28	0 / 20
other Total, other adverse events	7 / 28	6 / 20
serious Total, serious adverse events	3 / 28	2 / 20

Outcome results

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.