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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The proposed study will determine if cognitive behavioral therapy will help improve loneliness in people who use opioids.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | CBT delivered over the course of 6, ~45 minute sessions delivered via telehealth. |
|
| Health Education | Active Comparator | Health education sessions delivered over the course of 6, ~45 minute sessions delivered via telehealth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for loneliness (CBT-L) | Behavioral | 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline to 2 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Percent Days Abstinent From Opioids | Participants will complete a calendar indicating the type and frequency of drug use. | baseline to 2 months post-treatment |
| Mean Change in Percent Days Abstinent From Other Drugs |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
Participant data is available upon request as part of scientific collaboration.
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Participants in both conditions receive a baseline assessment and then are randomized to either CBT or Health Education.
Potential participants were recruited from social networking platforms. Recruitment started 08/2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | baseline to 2 months post-treatment |
|
Adverse event data were collected over a period of approximately 4 months from baseline to 2-months post-treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| increase in psychiatric distress | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisham Ashrafioun | University of Rochester | 585-430-2026 | lisham_ashrafioun@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2022 | Nov 7, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2022 | Jul 10, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Physical Health Education Training (PHET) | Behavioral | Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle. |
|
Participants will complete a calendar indicating the type and frequency of drug use.
| baseline to 2 months |
| 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. | baseline to 2 months post-treatment |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| UCLA Loneliness Scale | 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 | Standard Deviation | units on a scale - loneliness |
|
| Duke Social Support Index-Perceived Social Support | Duke Social Support Index-Perceived Social Support subscale assesses perceived social support. Higher scores indicate a higher perceived social support. Scores range from 6 to 18. | Mean | Standard Deviation | units on a scale |
|
| Percent days abstinent from opioids | Participants will complete a calendar indicating the type and frequency of drug use. Percent days abstinent from opioids is calculated by the number of days in which opioids were not used divided by the number of days in the assessment (i.e., 60). | Mean | Standard Deviation | percentage of days |
|
| 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. |
|
|
|
| Secondary | Mean Change in Percent Days Abstinent From Opioids | Participants will complete a calendar indicating the type and frequency of drug use. | Posted | Mean | Standard Deviation | percentage of days (abstinent/total) | baseline to 2 months post-treatment |
|
|
|
|
| Secondary | Mean Change in Percent Days Abstinent From Other Drugs | Participants will complete a calendar indicating the type and frequency of drug use. | Posted | Mean | Standard Deviation | percentage of days (abstinent/total) | baseline to 2 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | baseline to 2 months post-treatment |
|
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|
| 0 |
| 63 |
| 0 |
| 63 |
| 1 |
| 63 |
| EG001 | 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. | 0 | 62 | 0 | 62 | 1 | 62 |
| drug withdrawal | Psychiatric disorders | Non-systematic Assessment |
|
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