Intravenous Drug UsageNCT04943432

Open Trial of a Behavioral Activation Telepsychology Intervention for People Who Inject Drugs

A study testing Behavioral Activation in people with Intravenous Drug Usage, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Intravenous Drug Usage
What is being tested?: Behavioral Activation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: 29 Sep 2021to 8 May 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

At least 18 years of age
Reports regular recent injection drug use (defined as injecting drugs on at least one day in the last week and injecting drugs for at least two months)
Can identify at least one goal or area of change to address during treatment
Has regular (at least twice weekly) access to an electronic device that can make phone or video calls and has access to the internet to complete online questionnaires

Who cannot join

Attending or on a wait list to receive psychosocial substance use treatment
<5th grade reading level
Impairment due to active psychosis
Unable to give informed, voluntary, written consent to participate.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

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.

Conditions: Intravenous Drug Usage
Being tested: Behavioral Activation
Keywords: People who inject drugs, Behavioral Activation, Telepsychology, Psychosocial Treatment, Harm Reduction, Low-threshold
Medical subject headings: Harm Reduction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Behavioral ActivationBehavioural
8 sessions of harm reduction-focused Behavioral Activation for Substance Use

Study groups in NCT04943432
Study group	Role	What they receive
People who inject drugs	Experimental	People who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention Receives: Behavioral: Behavioral Activation

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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

Secondary outcomes (7)

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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Sep 20218 May 2022

First posted29 Jun 2021
Study start29 Sep 2021
Primary completion8 May 2022
Study completion8 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Intravenous Drug UsageStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04943432
Sponsor's protocol ID: 19-1458
Other IDs: 1F31DA049457
Status last verified: Aug 2022
First submitted: 15 Jun 2021
Last updated: 30 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Intravenous Drug Usage trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Trial of a Behavioral Activation Telepsychology Intervention for People Who Inject Drugs
ClinicalTrials.gov ID: NCT04943432
Acronym / sponsor ID: 19-1458
Conditions: Intravenous Drug Usage
Keywords: People who inject drugs, Behavioral Activation, Telepsychology, Psychosocial Treatment, Harm Reduction, Low-threshold
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), University of North Carolina
Study start: 29 Sep 2021 (actual)
Primary completion: 8 May 2022 (actual)
Study completion: 8 May 2022 (actual)
First posted: 29 Jun 2021 (actual)
Results: Posted 30 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
People who inject drugs	Experimental	Behavioral: Behavioral ActivationPeople who inject drugs recruited from a needle exchange program who will participate in a psychosocial intervention

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

At least 18 years of age
Reports regular recent injection drug use (defined as injecting drugs on at least one day in the last week and injecting drugs for at least two months)
Can identify at least one goal or area of change to address during treatment
Has regular (at least twice weekly) access to an electronic device that can make phone or video calls and has access to the internet to complete online questionnaires

Key exclusion criteria (4 listed)

Attending or on a wait list to receive psychosocial substance use treatment
<5th grade reading level
Impairment due to active psychosis
Unable to give informed, voluntary, written consent to participate.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Behavioral Activation8 sessions of harm reduction-focused Behavioral Activation for Substance Use	Behavioural	People who inject drugs

Primary outcome

Change in Behavioral Activation Assessed With Behavioral Activation for Depression Scale (BADS) Score
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
Behavioral Activation for Depression Scale (BADS) total score; Scale range 0-150, higher scores indicate greater activation (positive outcome).
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)
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
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.
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)
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
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)
Change in Substance-related Problems Assessed With Short Inventory of Problems - Alcohol and Drugs (SIP) Score
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
Short Inventory of Problems - Alcohol and Drugs (SIP) total score; Scale range 0-45, higher scores indicate greater problems (negative outcome)
Treatment Attendance (Feasibility)
Time frame: During the intervention, or up to 6 weeks after the pretreatment assessment, where average treatment duration was 4 weeks
Number of treatment sessions attended; Range 0-8; Higher number indicates greater attendance (positive outcome)
Treatment Satisfaction Assessed With Client Satisfaction Questionnaire Score (Acceptability)
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
Client Satisfaction Questionnaire; Scale range 8 to 32, higher scores indicate greater satisfaction (positive outcome)
Therapeutic Alliance Assessed With Working Alliance Inventory Score (Acceptability)
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
Outcome is mean of all items on Working Alliance Inventory; Range 1-5, higher scores indicate greater therapeutic alliance (positive outcome)

7 secondary outcomes

Change in Depressive Symptoms Assessed With Patient Health Questionnaire 9 (PHQ-9 Depression) Score
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
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
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
Time frame: from Pretreatment up to 2 months posttreatment
Change in Substance Use Frequency Assessed With Timeline Followback (TLFB) Interview
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
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
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

Results and safety

Results posted to the registry on 30 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
People Who Inject Drugs	23	17

Primary outcome: Change in Behavioral Activation Assessed With Behavioral Activation for Depression Scale (BADS) Score

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. Mean (Standard Deviation). Unit: score on a scale

Measure	People Who Inject Drugs n = 22
T1	77.00 (28.93)
T2	86.75 (36.12)
T3	69.67 (17.99)

People Who Inject Drugs: p = 0.06, t-test, 2 sided
People Who Inject Drugs: p = 0.68, t-test, 2 sided

Population analysed: Data are included for all participants who provided valid assessment data.

Primary outcome: 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)

Measure	People Who Inject Drugs n = 22
T1	28.82 (4.80)
T2	30.25 (4.04)
T3	29.17 (4.44)

Population analysed: Data are included for all participants who provided valid assessment data.

Primary outcome: 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)

Measure	People Who Inject Drugs n = 22
T1	26.28 (6.77)
T2	32.62 (6.39)
T3	29.91 (6.60)

People Who Inject Drugs: p = .01, t-test, 2 sided
People Who Inject Drugs: p = .32, t-test, 2 sided

Population analysed: Data are included for all participants who provided valid assessment data.

Primary outcome: Change in Substance-related Problems Assessed With Short Inventory of Problems - Alcohol and Drugs (SIP) Score

Measure	People Who Inject Drugs n = 23
T1	22.92 (11.90)
T2	22.08 (12.55)
T3	33.34 (11.22)

People Who Inject Drugs: p = .44, t-test, 2 sided
People Who Inject Drugs: p = .007, t-test, 2 sided

Population analysed: Data are included for all participants who provided valid assessment data.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
People Who Inject Drugs	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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).

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Catherine E Paquette, MPS, MA principal investigator

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Activation in people with Intravenous Drug Usage, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Behavioral Activation Assessed With Behavioral Activation for Depression Scale (BADS) Score (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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04943432.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.