Trial Outcomes & Findings for Open Trial of a Behavioral Activation Telepsychology Intervention for People Who Inject Drugs (NCT NCT04943432)
NCT ID: NCT04943432
Last Updated: 2023-05-30
Results Overview
Behavioral Activation for Depression Scale (BADS) total score; Scale range 0-150, higher scores indicate greater activation (positive outcome).
COMPLETED
NA
23 participants
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
2023-05-30
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
Received Intervention
|
19
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open Trial of a Behavioral Activation Telepsychology Intervention for People Who Inject Drugs
Baseline characteristics by cohort
| Measure |
People Who Inject Drugs
n=23 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 7.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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 weeksPopulation: Data are included for all participants who provided valid assessment data.
Behavioral Activation for Depression Scale (BADS) total score; Scale range 0-150, higher scores indicate greater activation (positive outcome).
Outcome measures
| Measure |
People Who Inject Drugs
n=22 Participants
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
|
|---|---|
|
Change in Behavioral Activation Assessed With Behavioral Activation for Depression Scale (BADS) Score
T1
|
77.00 score on a scale
Standard Deviation 28.93
|
|
Change in Behavioral Activation Assessed With Behavioral Activation for Depression Scale (BADS) Score
T2
|
86.75 score on a scale
Standard Deviation 36.12
|
|
Change in Behavioral Activation Assessed With Behavioral Activation for Depression Scale (BADS) Score
T3
|
69.67 score on a scale
Standard Deviation 17.99
|
PRIMARY outcome
Timeframe: 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 weeksPopulation: Data are included for all participants who provided valid assessment data.
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.
Outcome measures
| Measure |
People Who Inject Drugs
n=22 Participants
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
|
|---|---|
|
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)
T1
|
28.82 score on a scale
Standard Deviation 4.80
|
|
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)
T2
|
30.25 score on a scale
Standard Deviation 4.04
|
|
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)
T3
|
29.17 score on a scale
Standard Deviation 4.44
|
PRIMARY outcome
Timeframe: 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 weeksPopulation: Data are included for all participants who provided valid assessment data.
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)
Outcome measures
| Measure |
People Who Inject Drugs
n=22 Participants
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
|
|---|---|
|
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)
T2
|
32.62 score on a scale
Standard Deviation 6.39
|
|
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)
T1
|
26.28 score on a scale
Standard Deviation 6.77
|
|
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)
T3
|
29.91 score on a scale
Standard Deviation 6.60
|
PRIMARY outcome
Timeframe: 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 weeksPopulation: Data are included for all participants who provided valid assessment data.
Short Inventory of Problems - Alcohol and Drugs (SIP) total score; Scale range 0-45, higher scores indicate greater problems (negative outcome)
Outcome measures
| Measure |
People Who Inject Drugs
n=23 Participants
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
|
|---|---|
|
Change in Substance-related Problems Assessed With Short Inventory of Problems - Alcohol and Drugs (SIP) Score
T1
|
22.92 score on a scale
Standard Deviation 11.90
|
|
Change in Substance-related Problems Assessed With Short Inventory of Problems - Alcohol and Drugs (SIP) Score
T2
|
22.08 score on a scale
Standard Deviation 12.55
|
|
Change in Substance-related Problems Assessed With Short Inventory of Problems - Alcohol and Drugs (SIP) Score
T3
|
33.34 score on a scale
Standard Deviation 11.22
|
PRIMARY outcome
Timeframe: During the intervention, or up to 6 weeks after the pretreatment assessment, where average treatment duration was 4 weeksPopulation: All participants who enrolled in the study
Number of treatment sessions attended; Range 0-8; Higher number indicates greater attendance (positive outcome)
Outcome measures
| Measure |
People Who Inject Drugs
n=23 Participants
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
|
|---|---|
|
Treatment Attendance (Feasibility)
All participants
|
4.5 Treatment sessions attended
Standard Deviation 3.4
|
|
Treatment Attendance (Feasibility)
Participants who attended at least one session
|
5.5 Treatment sessions attended
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: 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 weeksPopulation: Data are included for all participants who provided valid assessment data.
Client Satisfaction Questionnaire; Scale range 8 to 32, higher scores indicate greater satisfaction (positive outcome)
Outcome measures
| Measure |
People Who Inject Drugs
n=15 Participants
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
|
|---|---|
|
Treatment Satisfaction Assessed With Client Satisfaction Questionnaire Score (Acceptability)
|
28.9 score on a scale
Standard Deviation 3.0
|
PRIMARY outcome
Timeframe: 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 weeksPopulation: Data are included for all participants who provided valid assessment data.
Outcome is mean of all items on Working Alliance Inventory; Range 1-5, higher scores indicate greater therapeutic alliance (positive outcome)
Outcome measures
| Measure |
People Who Inject Drugs
n=15 Participants
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
|
|---|---|
|
Therapeutic Alliance Assessed With Working Alliance Inventory Score (Acceptability)
|
4.5 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 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 weeksPopulation: Data are included for all participants who provided valid assessment data.
Patient Health Questionnaire 9 (PHQ-9 Depression); Scale range 0-27, higher scores indicate greater depressive symptoms (negative outcome)
Outcome measures
| Measure |
People Who Inject Drugs
n=23 Participants
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
|
|---|---|
|
Change in Depressive Symptoms Assessed With Patient Health Questionnaire 9 (PHQ-9 Depression) Score
T1
|
14.17 score on a scale
Standard Deviation 9.54
|
|
Change in Depressive Symptoms Assessed With Patient Health Questionnaire 9 (PHQ-9 Depression) Score
T2
|
11.73 score on a scale
Standard Deviation 9.37
|
|
Change in Depressive Symptoms Assessed With Patient Health Questionnaire 9 (PHQ-9 Depression) Score
T3
|
15.14 score on a scale
Standard Deviation 8.07
|
SECONDARY outcome
Timeframe: 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 weeksPopulation: Data are included for all participants who provided valid assessment data.
General Anxiety Disorder-7 (GAD-7 Anxiety); Scale range 0-21, higher scores indicate greater anxiety symptoms (negative outcome)
Outcome measures
| Measure |
People Who Inject Drugs
n=22 Participants
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
|
|---|---|
|
Change in Anxiety Symptoms Assessed With General Anxiety Disorder-7 (GAD-7 Anxiety) Score
T1
|
10.14 score on a scale
Standard Deviation 7.46
|
|
Change in Anxiety Symptoms Assessed With General Anxiety Disorder-7 (GAD-7 Anxiety) Score
T2
|
11.31 score on a scale
Standard Deviation 6.86
|
|
Change in Anxiety Symptoms Assessed With General Anxiety Disorder-7 (GAD-7 Anxiety) Score
T3
|
11.22 score on a scale
Standard Deviation 7.56
|
SECONDARY outcome
Timeframe: 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 weeksPopulation: Data are included for all participants who provided valid assessment data.
HIV Risk Behavior Scale (HRBS); Scale range 0-55, higher scores indicate greater HIV risk behavior (negative outcome)
Outcome measures
| Measure |
People Who Inject Drugs
n=23 Participants
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
|
|---|---|
|
Change in HIV Risk Behaviors Assessed With HIV Risk Behavior Scale (HRBS) Score
T1
|
16.61 score on a scale
Standard Deviation 6.20
|
|
Change in HIV Risk Behaviors Assessed With HIV Risk Behavior Scale (HRBS) Score
T2
|
13.25 score on a scale
Standard Deviation 7.78
|
|
Change in HIV Risk Behaviors Assessed With HIV Risk Behavior Scale (HRBS) Score
T3
|
8.00 score on a scale
Standard Deviation 5.52
|
SECONDARY outcome
Timeframe: from Pretreatment up to 2 months posttreatmentPopulation: Results are not available for this outcome due to a survey programming error resulting in invalid data for the ASSIST.
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST); Scale range 0-44, higher scores indicate greater substance use risk (negative outcome)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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 weeksPopulation: Data are included for all participants who provided valid assessment data.
Percent days with any substance use, assessed via Timeline followback (TLFB) Interview; Range 0-100%, higher scores indicate greater substance use frequency (negative outcome)
Outcome measures
| Measure |
People Who Inject Drugs
n=22 Participants
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
|
|---|---|
|
Change in Substance Use Frequency Assessed With Timeline Followback (TLFB) Interview
T1
|
95.46 percentage of days
Standard Deviation 8.27
|
|
Change in Substance Use Frequency Assessed With Timeline Followback (TLFB) Interview
T2
|
85.28 percentage of days
Standard Deviation 27.47
|
|
Change in Substance Use Frequency Assessed With Timeline Followback (TLFB) Interview
T3
|
85.13 percentage of days
Standard Deviation 31.59
|
SECONDARY outcome
Timeframe: During the intervention, or up to 6 weeks after the baseline assessment, where average treatment duration was 4 weeksPopulation: 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.
Modified Goal Attainment Scale; Range 0-5, higher scores indicate greater goal attainment (positive outcome)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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 weeksPopulation: Data are included for all participants who provided valid assessment data.
Environmental Reward Observation Scale (EROS); Scale range 10-40, higher scores indicate greater environmental reward (positive outcome)
Outcome measures
| Measure |
People Who Inject Drugs
n=16 Participants
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
|
|---|---|
|
Environmental Reward Assessed With Environmental Reward Observation Scale (EROS) Score
T1
|
22.50 score on a scale
Standard Deviation 6.52
|
|
Environmental Reward Assessed With Environmental Reward Observation Scale (EROS) Score
T2
|
28.0 score on a scale
Standard Deviation 5.79
|
|
Environmental Reward Assessed With Environmental Reward Observation Scale (EROS) Score
T3
|
22.80 score on a scale
Standard Deviation 6.53
|
Adverse Events
People Who Inject Drugs
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Catherine Paquette, MA, MPS
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place