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| ID | Type | Description | Link |
|---|---|---|---|
| 1F31DA049457 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| University of North Carolina | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People who inject drugs | Experimental | People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation | Behavioral | 8 sessions of harm reduction-focused Behavioral Activation for Substance Use |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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) | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine E Paquette, MPS, MA | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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).
9 to 36 months following publication
The investigator who proposes to use the data has IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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| ID | Title | Description |
|---|---|---|
| FG000 | People Who Inject Drugs | People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention Behavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who completed the pretreatment assessment and enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | People Who Inject Drugs | People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention. Behavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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). | Data are included for all participants who provided valid assessment data. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
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).
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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 | People Who Inject Drugs | People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention. Behavioral Activation: 8 sessions of harm reduction-focused Behavioral Activation for Substance Use |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Paquette, MA, MPS | University of North Carolina at Chapel Hill | 919-962-5082 | cpaq@live.unc.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 | Feb 28, 2023 | Mar 10, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 14, 2021 | Aug 16, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D040261 | Harm Reduction |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Treatment Attendance (Feasibility) | Number of treatment sessions attended; Range 0-8; Higher number indicates greater attendance (positive outcome) | 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) | 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) | 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 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) | 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) | 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) | 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) | 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) | 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) | 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 |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | 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. | Data are included for all participants who provided valid assessment data. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
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| Primary | 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) | Data are included for all participants who provided valid assessment data. | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| Primary | 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) | Data are included for all participants who provided valid assessment data. | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| Primary | Treatment Attendance (Feasibility) | Number of treatment sessions attended; Range 0-8; Higher number indicates greater attendance (positive outcome) | All participants who enrolled in the study | Posted | Mean | Standard Deviation | Treatment sessions attended | During the intervention, or up to 6 weeks after the pretreatment assessment, where average treatment duration was 4 weeks |
|
|
|
| Primary | Treatment Satisfaction Assessed With Client Satisfaction Questionnaire Score (Acceptability) | Client Satisfaction Questionnaire; Scale range 8 to 32, higher scores indicate greater satisfaction (positive outcome) | Data are included for all participants who provided valid assessment data. | Posted | Mean | Standard Deviation | score on a scale | 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 |
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|
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| Primary | 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) | Data are included for all participants who provided valid assessment data. | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| Secondary | 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) | Data are included for all participants who provided valid assessment data. | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| Secondary | 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) | Data are included for all participants who provided valid assessment data. | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| Secondary | 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) | Data are included for all participants who provided valid assessment data. | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| Secondary | 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) | Results are not available for this outcome due to a survey programming error resulting in invalid data for the ASSIST. | Posted | from Pretreatment up to 2 months posttreatment |
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| Secondary | 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) | Data are included for all participants who provided valid assessment data. | Posted | Mean | Standard Deviation | percentage of days | 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 |
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| Secondary | Goal Attainment Assessed With Modified Goal Attainment Scale Score | Modified Goal Attainment Scale; Range 0-5, higher scores indicate greater goal attainment (positive outcome) | This outcome measure was dropped (never added to the survey) as it was not one of the primary or secondary outcomes delineated in the study protocol. Data for this measure were not collected. | Posted | During the intervention, or up to 6 weeks after the baseline assessment, where average treatment duration was 4 weeks |
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| Secondary | 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) | Data are included for all participants who provided valid assessment data. | Posted | Mean | Standard Deviation | score on a scale | 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 |
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