Substance Use and Loneliness

Addressing Loneliness and Substance Use With Telehealth CBT

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05338268

Enrollment

Registered

2022-04-21

Start date

2022-09-30

Completion date

2024-12-31

Last updated

2026-02-18

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

Conditions

Substance Use Disorders

Keywords

Loneliness, Substance use disorders, social isolation, drug use

Brief summary

Background: Loneliness-a subjective emotional state characterized by the perception of social isolation-is a psychosocial factor that is associated with increased mortality, substance use, and is associated with precipitants of relapse among individuals with substance use disorders (SUD). Importantly, there are effective interventions that can be used to decrease loneliness; however, these have not been tested on Veterans with SUD who are lonely. Significance/Impact: Individuals with SUD have higher prevalence of loneliness and loneliness exacerbates pain and sleep disturbance, risk factors of relapse. Without effectively intervening on loneliness, Veterans with SUD will continue to be at high risk of relapse and will maintain problems engaging with social support, including healthcare providers-factors critical for recovery. Cognitive-behavioral therapies (CBT) has shown the strongest effects on loneliness, however, there are no interventions that are specifically designed for substance using populations who are lonely. Testing CBT for loneliness and SUD (CBT-L/SUD) has the potential to have a broad impact on addressing a critical, unmet need that commonly affects Veterans with SUD. The investigators approach of national recruitment and telehealth delivery of this intervention highlights how this this study address VHA care priorities including substance use, access to care, and telehealth. Innovation: There are no studies that have tested a loneliness intervention in Veterans with SUD who are lonely, which may neglect a broader impact on mental and physical health. This study is ideally situated to generate new and important knowledge on the association of loneliness and SUD. This study seeks to address a transdiagnostic factor, which may improve engagement with social support thereby reducing substance use. An additional innovative aspect of this study is recruitment being conducted outside the VHA. This may increase access to care among those Veterans who are especially isolated. Specific Aims: the investigators aim to: (1) refine the CBT-L/SUD manual by conducting a one-arm trial among Veterans with a SUD who report loneliness (n = 6), (2) randomize participants to receive either CBT-L/SUD (n = 15) or CBT-SUD (n = 15) to assess feasibility and acceptability among Veterans with a SUD who report loneliness. Methodology: the investigators will elicit feedback on a draft of the CBT-L/SUD manual then conduct a small single-arm trial (n = 6) for further refinement. Specifically, SUD treatment providers and Veterans with SUD will provide feedback on the draft manual, which the research team will integrate to finalize the manual for a small single-arm trial. This trial will allow us to collect feasibility of treatment delivery, and treatment satisfaction and acceptability data to further refine the manual. With the refined manual Veterans with SUD reporting loneliness will be randomized to either CBT-L/SUD (n = 15) or CBT-SUD (n = 15). The investigators will assess: (1) treatment acceptability, (2) participant adherence to treatment, and (3) therapist fidelity. The investigators will also assess outcome measure completion percentage, means and standard deviations, and level of correlation of repeated measurement of primary loneliness outcomes and secondary substance use outcomes. Implementation/Next Steps: Results from this study will provide critical feasibility and acceptability data to inform an HSR&D Merit Award application to conduct a fully-powered randomized controlled trial. The research team will work with the VA Office of Mental Health and Suicide Prevention and the Substance Use Disorder office of the National Mental Health Program to identify implementation and dissemination efforts. For example, the investigators plan to translate findings into applied practice across various settings (e.g., primary care mental health, rehabilitation treatment programs). Additionally, this intervention may be particularly useful for behavioral telehealth centers that deliver evidence-based interventions to rural and other Veterans who have difficulty accessing VHA care.

Interventions

BEHAVIORALCBT for Loneliness

CBT focused on social relationships and loneliness delivered over the course of 8, \~45 minute sessions delivered via telehealth.

BEHAVIORALCBT for Substance Use Disorder

CBT focused on substance use disorders delivered over the course of 8, \~45 minute sessions delivered via telehealth.

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

* Participants must be ages 18+, * understand English, * have access to a phone or computer, * screen positive for an active, at least moderate SUD. SUD include alcohol, marijuana, opioids, cocaine, other psychomotor stimulants (methamphetamine, amphetamines), and sedative/hypnotic/anxiolytic use disorders. * Participants will need to screen positive for loneliness.

Exclusion criteria

* Participant with significant cognitive impairment will be excluded.

Design outcomes

Primary

Measure	Time frame	Description
Mean Change in Loneliness From Baseline to 1-month Post-treatment Follow-up	baseline to 1-month post-treatment follow-up	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.

Secondary

Measure	Time frame	Description
Mean Change in Number of Days of Substance Use From Baseline to 1-month Post-treatment Follow-up	baseline to 1-month post-treatment follow-up	Participants will complete a calendar indicating the type and frequency of substance use.
Mean Change in Percent Days Abstinent From Baseline to 1-month Post-treatment Follow-up	baseline to 1-month post-treatment follow-up	Participants will complete a calendar indicating the type and frequency of substance use
Mean Change in Social Interactions Baseline to 1-month Post-treatment Follow-up	baseline to 1-month post-treatment follow-up	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLisham Ashrafioun, PhD

VA Finger Lakes Healthcare System, Canandaigua, NY

Participant flow

Recruitment details

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

Pre-assignment details

The first 6 participants all received CBT for Loneliness after a baseline assessments. For the next 30 participants, participants in both conditions receive a baseline assessment and then were randomized to either CBT for Substance Use Disorders or CBT for Loneliness.

Participants by arm

Arm	Count
CBT for Loneliness CBT for social relationships and loneliness delivered over the course of 8, \ 45 minute sessions delivered via telehealth.	20
CBT for Substance Use Disorder CBT for substance use disorders delivered over the course of 8, \ 45 minute sessions delivered via telehealth.	16
Total	36

Baseline characteristics

Characteristic	Total	CBT for Loneliness	CBT for Substance Use Disorder
Age, Continuous	42.39 Years STANDARD_DEVIATION 13	44.45 Years STANDARD_DEVIATION 14	39.81 Years STANDARD_DEVIATION 11.55
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants	2 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants	18 Participants	14 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	9 Participants	6 Participants	3 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	26 Participants	13 Participants	13 Participants
Sex: Female, Male Female	8 Participants	4 Participants	4 Participants
Sex: Female, Male Male	28 Participants	16 Participants	12 Participants
UCLA Loneliness Scale	55.7 units on a scale STANDARD_DEVIATION 11.7	51.3 units on a scale STANDARD_DEVIATION 13.4	59.5 units on a scale STANDARD_DEVIATION 9.4

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 20	0 / 16
other Total, other adverse events	3 / 20	1 / 16
serious Total, serious adverse events	1 / 20	0 / 16

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.