Trial Outcomes & Findings for Substance Use and Loneliness (NCT NCT05338268)

NCT ID: NCT05338268

Last Updated: 2026-01-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: baseline to 1-month post-treatment
• Results posted on: 2026-01-15

Participant Flow

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

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.

Participant milestones

Measure	CBT for Loneliness CBT focused on social relationships and loneliness delivered over the course of 8, \~45 minute sessions delivered via telehealth.	CBT for Substance Use Disorder CBT focused on substance use disorders delivered over the course of 8, \~45 minute sessions delivered via telehealth.
Overall Study STARTED	20	16
Overall Study COMPLETED	9	5
Overall Study NOT COMPLETED	11	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Substance Use and Loneliness

Baseline characteristics by cohort

Measure	CBT for Loneliness n=20 Participants CBT for social relationships and loneliness delivered over the course of 8, \~45 minute sessions delivered via telehealth.	CBT for Substance Use Disorder n=16 Participants CBT for substance use disorders delivered over the course of 8, \~45 minute sessions delivered via telehealth.	Total n=36 Participants Total of all reporting groups
Age, Continuous	44.45 Years STANDARD_DEVIATION 14.0 • n=14 Participants	39.81 Years STANDARD_DEVIATION 11.55 • n=10 Participants	42.39 Years STANDARD_DEVIATION 13.0 • n=24 Participants
Sex: Female, Male Female	4 Participants n=14 Participants	4 Participants n=10 Participants	8 Participants n=24 Participants
Sex: Female, Male Male	16 Participants n=14 Participants	12 Participants n=10 Participants	28 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	1 Participants n=14 Participants	0 Participants n=10 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	6 Participants n=14 Participants	3 Participants n=10 Participants	9 Participants n=24 Participants
Race (NIH/OMB) White	13 Participants n=14 Participants	13 Participants n=10 Participants	26 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=14 Participants	2 Participants n=10 Participants	4 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=14 Participants	14 Participants n=10 Participants	32 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants

PRIMARY outcome

Timeframe: baseline to 1-month post-treatment

Population: 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.

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.

Outcome measures

Measure	CBT for Loneliness n=8 Participants CBT focused on social relationships and loneliness delivered over the course of 8, \~45 minute sessions delivered via telehealth.	CBT for Substance Use Disorder n=5 Participants CBT focused on substance use disorders delivered over the course of 8, \~45 minute sessions delivered via telehealth.
Mean Change in Loneliness	-1.38 score on a scale Standard Deviation 17.82	-5.40 score on a scale Standard Deviation 3.58

SECONDARY outcome

Timeframe: baseline to 1-month post-treatment

Population: 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. Data missing for one participant in each arm compared to other outcomes of interest.

Participants will complete a calendar indicating the type and frequency of substance use.

Outcome measures

Measure	CBT for Loneliness n=7 Participants CBT focused on social relationships and loneliness delivered over the course of 8, \~45 minute sessions delivered via telehealth.	CBT for Substance Use Disorder n=4 Participants CBT focused on substance use disorders delivered over the course of 8, \~45 minute sessions delivered via telehealth.
Mean Change in Number of Days of Substance Use	-1.79 percentage of days (used/total) Standard Deviation 3.74	-1.75 percentage of days (used/total) Standard Deviation 1.26

SECONDARY outcome

Timeframe: baseline to 1-month post-treatment

Population: 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. Data missing for one participant in each arm compared to other outcomes of interest.

Participants will complete a calendar indicating the type and frequency of substance use

Outcome measures

Measure	CBT for Loneliness n=7 Participants CBT focused on social relationships and loneliness delivered over the course of 8, \~45 minute sessions delivered via telehealth.	CBT for Substance Use Disorder n=4 Participants CBT focused on substance use disorders delivered over the course of 8, \~45 minute sessions delivered via telehealth.
Mean Change in Percent Days Abstinent	5.95 percentage of days (abstinent/total) Standard Deviation 12.74	5.83 percentage of days (abstinent/total) Standard Deviation 4.19

SECONDARY outcome

Timeframe: baseline to 1-month post-treatment

Population: 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.

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.

Outcome measures

Measure	CBT for Loneliness n=8 Participants CBT focused on social relationships and loneliness delivered over the course of 8, \~45 minute sessions delivered via telehealth.	CBT for Substance Use Disorder n=5 Participants CBT focused on substance use disorders delivered over the course of 8, \~45 minute sessions delivered via telehealth.
Mean Change in Social Interactions	.38 units on a scale Standard Deviation 6.05	4.00 units on a scale Standard Deviation 1.73

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to 1-month post-treatment

Population: 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.

Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.

Outcome measures

Measure	CBT for Loneliness n=8 Participants CBT focused on social relationships and loneliness delivered over the course of 8, \~45 minute sessions delivered via telehealth.	CBT for Substance Use Disorder n=5 Participants CBT focused on substance use disorders delivered over the course of 8, \~45 minute sessions delivered via telehealth.
Mean Change in Depression	-2.00 units on a scale Standard Deviation 6.95	-2.80 units on a scale Standard Deviation 2.17

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to 1-month post-treatment

Population: 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.

Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.

Outcome measures

Measure	CBT for Loneliness n=8 Participants CBT focused on social relationships and loneliness delivered over the course of 8, \~45 minute sessions delivered via telehealth.	CBT for Substance Use Disorder n=8 Participants CBT focused on substance use disorders delivered over the course of 8, \~45 minute sessions delivered via telehealth.
Mean Change in Anxiety	.13 units on a scale Standard Deviation 4.45	-5.80 units on a scale Standard Deviation 3.11

Adverse Events

CBT for Loneliness

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

CBT for Substance Use Disorder

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	CBT for Loneliness n=20 participants at risk CBT focused on social relationships and loneliness delivered over the course of 8, \~45 minute sessions delivered via telehealth.	CBT for Substance Use Disorder n=16 participants at risk CBT focused on substance use disorders delivered over the course of 8, \~45 minute sessions delivered via telehealth.
Psychiatric disorders hospitalization - detoxification	5.0% 1/20 • Number of events 1 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)	0.00% 0/16 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)
Gastrointestinal disorders hospitalization - GI issues	5.0% 1/20 • Number of events 1 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)	0.00% 0/16 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)

Other adverse events

Measure	CBT for Loneliness n=20 participants at risk CBT focused on social relationships and loneliness delivered over the course of 8, \~45 minute sessions delivered via telehealth.	CBT for Substance Use Disorder n=16 participants at risk CBT focused on substance use disorders delivered over the course of 8, \~45 minute sessions delivered via telehealth.
Psychiatric disorders Increased psychiatric distress/substance use	15.0% 3/20 • Number of events 3 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)	6.2% 1/16 • Number of events 1 • from enrollment until end of follow-up (baseline assessment, post-treatment assessment, 1-month follow-up; 8 intervention session; ~3 months)

Additional Information

Lisham Ashrafioun

VA Finger Lakes Healthcare System

Phone: 585-430-2026

Email: Lisham.ashrafioun@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place