Loneliness, Opioid Use
Conditions
Brief summary
The proposed study will determine if cognitive behavioral therapy will help improve loneliness in people who use opioids.
Detailed description
The proposed study will be the first to assess the cognitive, affective, and behavioral pathways by which loneliness impacts opioid use. Individuals with an opioid use disorder (OUD) reporting loneliness will be randomized to either a 6-session Cognitive- Behavioral Therapy for loneliness (CBT-L) or a 6-session education control condition, both delivered via telehealth. Telehealth delivery can be easily implemented and can increase reach and access to individuals not engaged in treatment. We will use an established brief CBT manual to address loneliness. We will assess loneliness, negative affect (i.e., depression and anxiety), and the quality and quantity of social interactions prior to, during, and after the intervention to evaluate the subsequent impact on opioid use trajectories. Participant will complete questionnaires pre-treatment, post-treatment, and at 1- and 2-months posttreatment.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALPhysical Health Education Training (PHET)
Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be ages 18+ * Understand English * Have internet access * Screen positive for an active OUD on the OUD Module of the Structured Clinical Interview for DSM-5 (Diagnostic & Statistical Manual of Mental Disorder, 5th edition) Research Version (SCID-5-RV) * Screen positive for loneliness by scoring at least a T-score \> 60 on the NIH Toolbox Loneliness Scale
Exclusion criteria
* Consistent with previously used telehealth-delivered assessments, we will exclude any participant with cognitive impairment as measured by the Blessed Orientation-Memory-Concentration Test (BOMC) * Potential participants who are in the process of detoxifying as measured by the Subjective Opiate Withdrawal Scale will also be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Loneliness | baseline to 2 months post-treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Percent Days Abstinent From Opioids | baseline to 2 months post-treatment | Participants will complete a calendar indicating the type and frequency of drug use. |
| Mean Change in Percent Days Abstinent From Other Drugs | baseline to 2 months | Participants will complete a calendar indicating the type and frequency of drug use. |
| Mean Change in Social Support | baseline to 2 months 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 or perceived social support. Scores range from 6 to 18. |
Countries
United States
Participant flow
Recruitment details
Potential participants were recruited from social networking platforms. Recruitment started 08/2021.
Pre-assignment details
Participants in both conditions receive a baseline assessment and then are randomized to either CBT or Health Education.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 63 |
| 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. | 62 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 17 | 18 |
Baseline characteristics
| Characteristic | Cognitive Behavioral Therapy (CBT) | Health Education | Total |
|---|---|---|---|
| Age, Continuous | 45.5 years STANDARD_DEVIATION 12.8 | 42.2 years STANDARD_DEVIATION 9.7 | 43.8 years STANDARD_DEVIATION 11.4 |
| Duke Social Support Index-Perceived Social Support | 11.4 units on a scale STANDARD_DEVIATION 2.9 | 11.7 units on a scale STANDARD_DEVIATION 3.1 | 11.5 units on a scale STANDARD_DEVIATION 3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 58 Participants | 116 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Percent days abstinent from opioids | 40.7 percentage of days STANDARD_DEVIATION 36.6 | 33.0 percentage of days STANDARD_DEVIATION 34.6 | 36.9 percentage of days STANDARD_DEVIATION 35.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 19 Participants | 32 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 45 Participants | 39 Participants | 84 Participants |
| Sex: Female, Male Female | 36 Participants | 36 Participants | 72 Participants |
| Sex: Female, Male Male | 27 Participants | 26 Participants | 53 Participants |
| UCLA Loneliness Scale | 58.0 units on a scale - loneliness STANDARD_DEVIATION 9.1 | 58.5 units on a scale - loneliness STANDARD_DEVIATION 7.9 | 58.2 units on a scale - loneliness STANDARD_DEVIATION 8.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 62 |
| other Total, other adverse events | 1 / 63 | 1 / 62 |
| serious Total, serious adverse events | 0 / 63 | 0 / 62 |
Outcome results
Primary
Mean Change in Loneliness
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.
Time frame: baseline to 2 months post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Mean Change in Loneliness | -8.3 score on a scale | Standard Deviation 14.9 |
| Health Education | Mean Change in Loneliness | -10.3 score on a scale | Standard Deviation 12.5 |
p-value: >0.05Latent growth modeling
Secondary
Mean Change in Percent Days Abstinent From Opioids
Participants will complete a calendar indicating the type and frequency of drug use.
Time frame: baseline to 2 months post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Mean Change in Percent Days Abstinent From Opioids | 40 percentage of days (abstinent/total) | Standard Deviation 43 |
| Health Education | Mean Change in Percent Days Abstinent From Opioids | 20 percentage of days (abstinent/total) | Standard Deviation 30 |
p-value: <0.001Latent growth modeling
Secondary
Mean Change in Percent Days Abstinent From Other Drugs
Participants will complete a calendar indicating the type and frequency of drug use.
Time frame: baseline to 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Mean Change in Percent Days Abstinent From Other Drugs | 30 percentage of days (abstinent/total) | Standard Deviation 42 |
| Health Education | Mean Change in Percent Days Abstinent From Other Drugs | 14 percentage of days (abstinent/total) | Standard Deviation 33 |
p-value: <0.01Latent growth modeling
Secondary
Mean Change in Social Support
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 or perceived social support. Scores range from 6 to 18.
Time frame: baseline to 2 months post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Mean Change in Social Support | 1.6 score on a scale | Standard Deviation 3.4 |
| Health Education | Mean Change in Social Support | 1.0 score on a scale | Standard Deviation 3 |
p-value: >0.05Latent growth modeling