Intravenous Drug Usage
Conditions
Keywords
People who inject drugs, Behavioral Activation, Telepsychology, Psychosocial Treatment, Harm Reduction, Low-threshold
Brief summary
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.
Interventions
BEHAVIORALBehavioral Activation
8 sessions of harm reduction-focused Behavioral Activation for Substance Use
Sponsors
National Institute on Drug Abuse (NIDA)
University of North Carolina
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic Alliance Assessed With Working Alliance Inventory Score (Acceptability) | 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) |
| Change in Behavioral Activation Assessed With Behavioral Activation for Depression Scale (BADS) Score | 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) | 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) | 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 | 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) | 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) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depressive Symptoms Assessed With Patient Health Questionnaire 9 (PHQ-9 Depression) Score | 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 | Patient Health Questionnaire 9 (PHQ-9 Depression); Scale range 0-27, higher scores indicate greater depressive symptoms (negative outcome) |
| Change in Anxiety Symptoms Assessed With General Anxiety Disorder-7 (GAD-7 Anxiety) Score | 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 | General Anxiety Disorder-7 (GAD-7 Anxiety); Scale range 0-21, higher scores indicate greater anxiety symptoms (negative outcome) |
| Change in HIV Risk Behaviors Assessed With HIV Risk Behavior Scale (HRBS) Score | 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 | HIV Risk Behavior Scale (HRBS); Scale range 0-55, higher scores indicate greater HIV risk behavior (negative outcome) |
| Change in Substance Use Risk Assessed With Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Score | from Pretreatment up to 2 months posttreatment | Alcohol, Smoking and Substance Involvement Screening Test (ASSIST); Scale range 0-44, higher scores indicate greater substance use risk (negative outcome) |
| Change in Substance Use Frequency Assessed With Timeline Followback (TLFB) Interview | 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 | Percent days with any substance use, assessed via Timeline followback (TLFB) Interview; Range 0-100%, higher scores indicate greater substance use frequency (negative outcome) |
| Goal Attainment Assessed With Modified Goal Attainment Scale Score | During the intervention, or up to 6 weeks after the baseline assessment, where average treatment duration was 4 weeks | Modified Goal Attainment Scale; Range 0-5, higher scores indicate greater goal attainment (positive outcome) |
| Environmental Reward Assessed With Environmental Reward Observation Scale (EROS) Score | 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 | Environmental Reward Observation Scale (EROS); Scale range 10-40, higher scores indicate greater environmental reward (positive outcome) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | People Who Inject Drugs |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 35.4 years STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 23 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
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).
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
Population: Data are included for all participants who provided valid assessment data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| People Who Inject Drugs | Change in Behavioral Activation Assessed With Behavioral Activation for Depression Scale (BADS) Score | T1 | 77.00 score on a scale | Standard Deviation 28.93 |
| People Who Inject Drugs | Change in Behavioral Activation Assessed With Behavioral Activation for Depression Scale (BADS) Score | T2 | 86.75 score on a scale | Standard Deviation 36.12 |
| People Who Inject Drugs | Change in Behavioral Activation Assessed With Behavioral Activation for Depression Scale (BADS) Score | T3 | 69.67 score on a scale | Standard Deviation 17.99 |
Comparison: T2 - T1p-value: 0.06t-test, 2 sided
Comparison: T3 - T1p-value: 0.68t-test, 2 sided
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)
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
Population: Data are included for all participants who provided valid assessment data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| People Who Inject Drugs | 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 11.9 |
| People Who Inject Drugs | 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 |
| People Who Inject Drugs | 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 |
Comparison: T2-T1p-value: 0.44t-test, 2 sided
Comparison: T3-T1p-value: 0.007t-test, 2 sided
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.
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
Population: Data are included for all participants who provided valid assessment data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| People Who Inject Drugs | 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 4.8 |
| People Who Inject Drugs | 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 |
| People Who Inject Drugs | 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
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
Population: Data are included for all participants who provided valid assessment data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| People Who Inject Drugs | 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 |
| People Who Inject Drugs | 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 |
| People Who Inject Drugs | 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 6.6 |
Comparison: T2-T1p-value: 0.01t-test, 2 sided
Comparison: T3-T1p-value: 0.32t-test, 2 sided
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)
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
Population: Data are included for all participants who provided valid assessment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| People Who Inject Drugs | Therapeutic Alliance Assessed With Working Alliance Inventory Score (Acceptability) | 4.5 score on a scale | Standard Deviation 0.5 |
Primary
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
Population: All participants who enrolled in the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| People Who Inject Drugs | Treatment Attendance (Feasibility) | All participants | 4.5 Treatment sessions attended | Standard Deviation 3.4 |
| People Who Inject Drugs | Treatment Attendance (Feasibility) | Participants who attended at least one session | 5.5 Treatment sessions attended | Standard Deviation 2.9 |
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)
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
Population: Data are included for all participants who provided valid assessment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| People Who Inject Drugs | Treatment Satisfaction Assessed With Client Satisfaction Questionnaire Score (Acceptability) | 28.9 score on a scale | Standard Deviation 3 |
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)
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
Population: Data are included for all participants who provided valid assessment data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| People Who Inject Drugs | 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 |
| People Who Inject Drugs | 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 |
| People Who Inject Drugs | 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 |
Comparison: T2-T1p-value: 0.82t-test, 2 sided
Comparison: T3-T1p-value: 0.36t-test, 2 sided
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)
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
Population: Data are included for all participants who provided valid assessment data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| People Who Inject Drugs | 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 |
| People Who Inject Drugs | 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 |
| People Who Inject Drugs | 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 |
Comparison: T2-T1p-value: 0.01t-test, 2 sided
Comparison: T3-T1p-value: 0.11t-test, 2 sided
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)
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
Population: Data are included for all participants who provided valid assessment data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| People Who Inject Drugs | Change in HIV Risk Behaviors Assessed With HIV Risk Behavior Scale (HRBS) Score | T1 | 16.61 score on a scale | Standard Deviation 6.2 |
| People Who Inject Drugs | Change in HIV Risk Behaviors Assessed With HIV Risk Behavior Scale (HRBS) Score | T2 | 13.25 score on a scale | Standard Deviation 7.78 |
| People Who Inject Drugs | Change in HIV Risk Behaviors Assessed With HIV Risk Behavior Scale (HRBS) Score | T3 | 8.00 score on a scale | Standard Deviation 5.52 |
Comparison: T2-T1p-value: 0.34t-test, 2 sided
Comparison: T3-T1p-value: 0.02t-test, 2 sided
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)
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
Population: Data are included for all participants who provided valid assessment data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| People Who Inject Drugs | Change in Substance Use Frequency Assessed With Timeline Followback (TLFB) Interview | T1 | 95.46 percentage of days | Standard Deviation 8.27 |
| People Who Inject Drugs | Change in Substance Use Frequency Assessed With Timeline Followback (TLFB) Interview | T2 | 85.28 percentage of days | Standard Deviation 27.47 |
| People Who Inject Drugs | Change in Substance Use Frequency Assessed With Timeline Followback (TLFB) Interview | T3 | 85.13 percentage of days | Standard Deviation 31.59 |
Comparison: T2-T1p-value: 0.14t-test, 2 sided
Comparison: T3-T1p-value: 0.29t-test, 2 sided
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)
Time frame: from Pretreatment up to 2 months posttreatment
Population: Results are not available for this outcome due to a survey programming error resulting in invalid data for the ASSIST.
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)
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
Population: Data are included for all participants who provided valid assessment data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| People Who Inject Drugs | Environmental Reward Assessed With Environmental Reward Observation Scale (EROS) Score | T1 | 22.50 score on a scale | Standard Deviation 6.52 |
| People Who Inject Drugs | Environmental Reward Assessed With Environmental Reward Observation Scale (EROS) Score | T2 | 28.0 score on a scale | Standard Deviation 5.79 |
| People Who Inject Drugs | Environmental Reward Assessed With Environmental Reward Observation Scale (EROS) Score | T3 | 22.80 score on a scale | Standard Deviation 6.53 |
Comparison: T2-T1p-value: <0.001t-test, 2 sided
Comparison: T3-T1p-value: 0.23t-test, 2 sided
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)
Time frame: During the intervention, or up to 6 weeks after the baseline assessment, where average treatment duration was 4 weeks
Population: 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.