Trial Outcomes & Findings for The Association Between Loneliness and Substance Use (NCT NCT04938492)
NCT ID: NCT04938492
Last Updated: 2025-02-11
Results Overview
Loneliness will be measured using the University of California-Los Angeles (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
125 participants
Primary outcome timeframe
baseline to 2 months post-treatment
Results posted on
2025-02-11
Participant Flow
Potential participants were recruited from social networking platforms. Recruitment started 08/2021.
Participants in both conditions receive a baseline assessment and then are randomized to either CBT or Health Education.
Participant milestones
| Measure |
Cognitive Behavioral Therapy (CBT)
CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Cognitive Behavioral Therapy for loneliness (CBT-L): 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.
|
Health Education
Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Physical Health Education Training (PHET): Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
62
|
|
Overall Study
COMPLETED
|
46
|
44
|
|
Overall Study
NOT COMPLETED
|
17
|
18
|
Reasons for withdrawal
| Measure |
Cognitive Behavioral Therapy (CBT)
CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Cognitive Behavioral Therapy for loneliness (CBT-L): 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.
|
Health Education
Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Physical Health Education Training (PHET): Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
17
|
18
|
Baseline Characteristics
The Association Between Loneliness and Substance Use
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Therapy (CBT)
n=63 Participants
CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Cognitive Behavioral Therapy for loneliness (CBT-L): 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.
|
Health Education
n=62 Participants
Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Physical Health Education Training (PHET): Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 12.8 • n=99 Participants
|
42.2 years
STANDARD_DEVIATION 9.7 • n=107 Participants
|
43.8 years
STANDARD_DEVIATION 11.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
UCLA Loneliness Scale
|
58.0 units on a scale - loneliness
STANDARD_DEVIATION 9.1 • n=99 Participants
|
58.5 units on a scale - loneliness
STANDARD_DEVIATION 7.9 • n=107 Participants
|
58.2 units on a scale - loneliness
STANDARD_DEVIATION 8.5 • n=206 Participants
|
|
Duke Social Support Index-Perceived Social Support
|
11.4 units on a scale
STANDARD_DEVIATION 2.9 • n=99 Participants
|
11.7 units on a scale
STANDARD_DEVIATION 3.1 • n=107 Participants
|
11.5 units on a scale
STANDARD_DEVIATION 3.0 • n=206 Participants
|
|
Percent days abstinent from opioids
|
40.7 percentage of days
STANDARD_DEVIATION 36.6 • n=99 Participants
|
33.0 percentage of days
STANDARD_DEVIATION 34.6 • n=107 Participants
|
36.9 percentage of days
STANDARD_DEVIATION 35.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: baseline to 2 months post-treatmentLoneliness will be measured using the University of California-Los Angeles (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 |
Cognitive Behavioral Therapy (CBT)
n=46 Participants
CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Cognitive Behavioral Therapy for loneliness (CBT-L): 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.
|
Health Education
n=44 Participants
Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Physical Health Education Training (PHET): Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.
|
|---|---|---|
|
Mean Change in Loneliness
|
-8.3 score on a scale
Standard Deviation 14.9
|
-10.3 score on a scale
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: baseline to 2 months post-treatmentParticipants will complete a calendar indicating the type and frequency of drug use.
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT)
n=46 Participants
CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Cognitive Behavioral Therapy for loneliness (CBT-L): 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.
|
Health Education
n=44 Participants
Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Physical Health Education Training (PHET): Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.
|
|---|---|---|
|
Mean Change in Percent Days Abstinent From Opioids
|
40 percentage of days (abstinent/total)
Standard Deviation 43
|
20 percentage of days (abstinent/total)
Standard Deviation 30
|
SECONDARY outcome
Timeframe: baseline to 2 monthsParticipants will complete a calendar indicating the type and frequency of drug use.
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT)
n=46 Participants
CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Cognitive Behavioral Therapy for loneliness (CBT-L): 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.
|
Health Education
n=44 Participants
Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Physical Health Education Training (PHET): Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.
|
|---|---|---|
|
Mean Change in Percent Days Abstinent From Other Drugs
|
30 percentage of days (abstinent/total)
Standard Deviation 42
|
14 percentage of days (abstinent/total)
Standard Deviation 33
|
SECONDARY outcome
Timeframe: baseline to 2 months post-treatmentDuke 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 or perceived social support. Scores range from 6 to 18.
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT)
n=46 Participants
CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Cognitive Behavioral Therapy for loneliness (CBT-L): 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.
|
Health Education
n=44 Participants
Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Physical Health Education Training (PHET): Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.
|
|---|---|---|
|
Mean Change in Social Support
|
1.6 score on a scale
Standard Deviation 3.4
|
1.0 score on a scale
Standard Deviation 3.0
|
Adverse Events
Cognitive Behavioral Therapy (CBT)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Health Education
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cognitive Behavioral Therapy (CBT)
n=63 participants at risk
CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Cognitive Behavioral Therapy for loneliness (CBT-L): 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.
|
Health Education
n=62 participants at risk
Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Physical Health Education Training (PHET): Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.
|
|---|---|---|
|
Psychiatric disorders
increase in psychiatric distress
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected over a period of approximately 4 months from baseline to 2-months post-treatment.
|
0.00%
0/62 • Adverse event data were collected over a period of approximately 4 months from baseline to 2-months post-treatment.
|
|
Psychiatric disorders
drug withdrawal
|
0.00%
0/63 • Adverse event data were collected over a period of approximately 4 months from baseline to 2-months post-treatment.
|
1.6%
1/62 • Number of events 1 • Adverse event data were collected over a period of approximately 4 months from baseline to 2-months post-treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place