An interventional study of Behavioral Activation in Intravenous Drug Usage, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-30.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
The study has two aims: 1) To examine the feasibility and acceptability of administering a telepsychology Behavioral Activation (BA) treatment for substance use among non-treatment-seeking people who inject drugs (PWID); 2) To test the initial efficacy of the treatment from pretreatment to a 1-month follow-up on substance-related problems, readiness to change drug use, and BA. The intervention is hypothesized to be feasible and well-accepted, and within-subject analyses are hypothesized to demonstrate decreases in substance-related problems and increases in readiness to change drug use and BA from pretreatment to a 1-month follow-up.
The study aims to recruit N=25 non-treatment-seeking PWID from a syringe exchange program (estimated treated sample n=15). Participants will receive 8 sessions of BA over 4 weeks, and assessment of study outcome measures will occur at pretreatment, post-treatment, and a one-month follow-up.
University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention
Behavioral: Behavioral Activation
8 sessions of harm reduction-focused Behavioral Activation for Substance Use
Change in Behavioral Activation Assessed With Behavioral Activation for Depression Scale (BADS) Score
Behavioral Activation for Depression Scale (BADS) total score; Scale range 0-150, higher scores indicate greater activation (positive outcome).
Time frame: pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks
Change in Substance Use Problem Recognition Score Assessed With Recognition Subscale of Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) Score (Readiness to Change Drug Use)
Outcome is subscale score on Recognition subscale of Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES); Range of 7-35, higher scores indicate greater problem recognition.
Time frame: pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks
Change in Taking Steps to Change Substance Use Assessed With Taking Steps Subscale of Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) Score (Readiness to Change Drug Use)
Outcome is subscale score on Taking Steps subscale of Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES); Range of 8-40, higher scores indicate greater steps to change (positive outcome)
Time frame: pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks
Change in Substance-related Problems Assessed With Short Inventory of Problems - Alcohol and Drugs (SIP) Score
Short Inventory of Problems - Alcohol and Drugs (SIP) total score; Scale range 0-45, higher scores indicate greater problems (negative outcome)
Time frame: pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks
Treatment Attendance (Feasibility)
Number of treatment sessions attended; Range 0-8; Higher number indicates greater attendance (positive outcome)
Time frame: During the intervention, or up to 6 weeks after the pretreatment assessment, where average treatment duration was 4 weeks
Treatment Satisfaction Assessed With Client Satisfaction Questionnaire Score (Acceptability)
Client Satisfaction Questionnaire; Scale range 8 to 32, higher scores indicate greater satisfaction (positive outcome)
Time frame: At the Posttreatment assessment (T2), which occurs after treatment completion or a maximum of 8 weeks after the pretreatment assessment, where average treatment duration was 4 weeks
Therapeutic Alliance Assessed With Working Alliance Inventory Score (Acceptability)
Outcome is mean of all items on Working Alliance Inventory; Range 1-5, higher scores indicate greater therapeutic alliance (positive outcome)
Time frame: At the Posttreatment assessment (T2), which occurs after treatment completion or a maximum of 8 weeks after the pretreatment assessment, where average treatment duration was 4 weeks
Change in Depressive Symptoms Assessed With Patient Health Questionnaire 9 (PHQ-9 Depression) Score
Patient Health Questionnaire 9 (PHQ-9 Depression); Scale range 0-27, higher scores indicate greater depressive symptoms (negative outcome)
Time frame: pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks
Change in Anxiety Symptoms Assessed With General Anxiety Disorder-7 (GAD-7 Anxiety) Score
General Anxiety Disorder-7 (GAD-7 Anxiety); Scale range 0-21, higher scores indicate greater anxiety symptoms (negative outcome)
Time frame: pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks
Change in HIV Risk Behaviors Assessed With HIV Risk Behavior Scale (HRBS) Score
HIV Risk Behavior Scale (HRBS); Scale range 0-55, higher scores indicate greater HIV risk behavior (negative outcome)
Time frame: pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks
Change in Substance Use Risk Assessed With Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Score
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST); Scale range 0-44, higher scores indicate greater substance use risk (negative outcome)
Time frame: from Pretreatment up to 2 months posttreatment
Change in Substance Use Frequency Assessed With Timeline Followback (TLFB) Interview
Percent days with any substance use, assessed via Timeline followback (TLFB) Interview; Range 0-100%, higher scores indicate greater substance use frequency (negative outcome)
Time frame: pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks
Goal Attainment Assessed With Modified Goal Attainment Scale Score
Modified Goal Attainment Scale; Range 0-5, higher scores indicate greater goal attainment (positive outcome)
Time frame: During the intervention, or up to 6 weeks after the baseline assessment, where average treatment duration was 4 weeks
Environmental Reward Assessed With Environmental Reward Observation Scale (EROS) Score
Environmental Reward Observation Scale (EROS); Scale range 10-40, higher scores indicate greater environmental reward (positive outcome)
Time frame: pretreatment (T1), immediately after (or up to 2 weeks after) treatment completion (T2), and 1 month (or up to 2 months) posttreatment (T3), where average treatment duration was 4 weeks
| Milestone | People Who Inject Drugs |
|---|---|
| Started | 23 |
| Received intervention | 19 |
| Completed | 17 |
| Not completed | 6 |
Behavioral Activation for Depression Scale (BADS) total score; Scale range 0-150, higher scores indicate greater activation (positive outcome).
| score on a scale | People Who Inject Drugs |
|---|---|
| T1 | 77.00 ± 28.93 |
| T2 | 86.75 ± 36.12 |
| T3 | 69.67 ± 17.99 |
Outcome is subscale score on Recognition subscale of Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES); Range of 7-35, higher scores indicate greater problem recognition.
| score on a scale | People Who Inject Drugs |
|---|---|
| T1 | 28.82 ± 4.80 |
| T2 | 30.25 ± 4.04 |
| T3 | 29.17 ± 4.44 |
Outcome is subscale score on Taking Steps subscale of Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES); Range of 8-40, higher scores indicate greater steps to change (positive outcome)
| score on a scale | People Who Inject Drugs |
|---|---|
| T1 | 26.28 ± 6.77 |
| T2 | 32.62 ± 6.39 |
| T3 | 29.91 ± 6.60 |
Short Inventory of Problems - Alcohol and Drugs (SIP) total score; Scale range 0-45, higher scores indicate greater problems (negative outcome)
| score on a scale | People Who Inject Drugs |
|---|---|
| T1 | 22.92 ± 11.90 |
| T2 | 22.08 ± 12.55 |
| T3 | 33.34 ± 11.22 |
Number of treatment sessions attended; Range 0-8; Higher number indicates greater attendance (positive outcome)
| Treatment sessions attended | People Who Inject Drugs |
|---|---|
| All participants | 4.5 ± 3.4 |
| Participants who attended at least one session | 5.5 ± 2.9 |
Client Satisfaction Questionnaire; Scale range 8 to 32, higher scores indicate greater satisfaction (positive outcome)
| score on a scale | People Who Inject Drugs |
|---|---|
| Treatment Satisfaction Assessed With Client Satisfaction Questionnaire Score (Acceptability) | 28.9 ± 3.0 |
Outcome is mean of all items on Working Alliance Inventory; Range 1-5, higher scores indicate greater therapeutic alliance (positive outcome)
| score on a scale | People Who Inject Drugs |
|---|---|
| Therapeutic Alliance Assessed With Working Alliance Inventory Score (Acceptability) | 4.5 ± 0.5 |
Patient Health Questionnaire 9 (PHQ-9 Depression); Scale range 0-27, higher scores indicate greater depressive symptoms (negative outcome)
| score on a scale | People Who Inject Drugs |
|---|---|
| T1 | 14.17 ± 9.54 |
| T2 | 11.73 ± 9.37 |
| T3 | 15.14 ± 8.07 |
General Anxiety Disorder-7 (GAD-7 Anxiety); Scale range 0-21, higher scores indicate greater anxiety symptoms (negative outcome)
| score on a scale | People Who Inject Drugs |
|---|---|
| T1 | 10.14 ± 7.46 |
| T2 | 11.31 ± 6.86 |
| T3 | 11.22 ± 7.56 |
HIV Risk Behavior Scale (HRBS); Scale range 0-55, higher scores indicate greater HIV risk behavior (negative outcome)
| score on a scale | People Who Inject Drugs |
|---|---|
| T1 | 16.61 ± 6.20 |
| T2 | 13.25 ± 7.78 |
| T3 | 8.00 ± 5.52 |
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST); Scale range 0-44, higher scores indicate greater substance use risk (negative outcome)
No measurements were reported for this outcome.
Percent days with any substance use, assessed via Timeline followback (TLFB) Interview; Range 0-100%, higher scores indicate greater substance use frequency (negative outcome)
| percentage of days | People Who Inject Drugs |
|---|---|
| T1 | 95.46 ± 8.27 |
| T2 | 85.28 ± 27.47 |
| T3 | 85.13 ± 31.59 |
Modified Goal Attainment Scale; Range 0-5, higher scores indicate greater goal attainment (positive outcome)
No measurements were reported for this outcome.
Environmental Reward Observation Scale (EROS); Scale range 10-40, higher scores indicate greater environmental reward (positive outcome)
| score on a scale | People Who Inject Drugs |
|---|---|
| T1 | 22.50 ± 6.52 |
| T2 | 28.0 ± 5.79 |
| T3 | 22.80 ± 6.53 |
Collected over From the time of informed consent through the 1-month follow-up assessment, a period of up to 3 months (where average duration was approximately 2 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| People Who Inject Drugs | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
Participants who completed the pretreatment assessment and enrolled in the study.
| Age, Categorical(Participants) | People Who Inject Drugs |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 23 |
| >=65 years | 0 |
| Age, Continuous(years) | People Who Inject Drugs |
|---|---|
| Mean | 35.4 ± 7.8 |
| Sex: Female, Male(Participants) | People Who Inject Drugs |
|---|---|
| Female | 12 |
| Male | 11 |
| Ethnicity (NIH/OMB)(Participants) | People Who Inject Drugs |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 22 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | People Who Inject Drugs |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 15 |
| More than one race | 5 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | People Who Inject Drugs |
|---|---|
| United States | 23 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina at Chapel Hill (UNC).
Supporting information: Study protocol, Sap, Icf, Analytic code
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill