Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05103514
Other study ID # SES- Longitudinal Study
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2025
Est. completion date July 1, 2028

Study information

Verified date April 2024
Source Virginia Polytechnic Institute and State University
Contact Warren K Bickel, PhD
Phone 540-526-2088
Email wkbickel@vt.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this study is to provide a scientific understanding of the impact of socioeconomic status (SES) on the recovery trajectory (psychosocial functioning, relapse/remission status, and neurocognitive mechanisms).


Description:

The study will characterize the effect of SES (subjective and objective indicators) on long-term trajectories of recovery and neurocognitive functioning. By using an accelerated longitudinal design, the investigators will examine the association between baseline SES, changes in CNDS, and changes in psychosocial functioning (e.g., quality of life) and relapse. Moreover, the investigators will use computational modeling to capture underlying changes in components of CNDS functioning related to SES and SUD recovery.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 675
Est. completion date July 1, 2028
Est. primary completion date April 1, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. be =18 yrs old 2. meet lifetime DSM-5 SUD criteria 3. have a Recovery Initiation Date less than 3 years prior to the time of enrollment 4. be able to read independently 5. be free of legal problems that could limit participation 6. reside in the U.S. 7. anticipate continued Internet access (to ensure ongoing contact and data collection) 8. be a registrant of the International Quit and Recovery Registry (IQRR) Exclusion Criteria: 1. Minors will not be included 2. Prisoners will not be included. If participants become incarcerated during this study, they will not be contacted to complete assessments during their incarceration. If the incarceration ends during the study, they may be contacted to participate in assessments. 3. Adults who are not capable of consenting on their own behalf

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Online Survey
There are no interventions planned for this study. This is an observational study only.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Virginia Polytechnic Institute and State University

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Socioeconomic Status (SES)- Individual Subjective SES Individual Subjective SES will be determined using the MacArthur Scale of subjective social status. Participants will be presented with two social ladders that have 10 steps each and asked to place themselves on the rung that best represent where they stand at this time in their life (1=lowest rung and 10= highest rung), relative to other people in (1) the United States and (2) their community. Higher scores on the 10-rung ladder indicate higher subjective SES. Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Primary Change in Socioeconomic Status (SES)- Individual Objective SES Individual Objective SES will be measured using a composite that was developed by the US Department of Justice (i.e. National Crime Victimization Survey Index 1) that incorporates four main SES elements (i.e., income, education, employment status, and housing tenure measures). Specifically, the SES composite index includes two individual level characteristics: education (possible range: 0-3) and employment in the last 6 months (possible range: 0-1); and two household level characteristics: income as a percentage of the federal poverty level (FPL; possible range: 0-3) and housing tenure (possible range: 0-1). The final SES score (possible range: 0-8) is collapsed into three levels: low (total score of 0 to less than 3), middle (total score of 3 to less than 6), and upper (total score of 6-8) SES. Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Primary Change in CNDS functioning Delay Discounting (DD) task will be administered to assesses the value of delayed reinforcers. Participants make hypothetical choices between amounts of delayed and immediate money at various delays (e.g., 1 day to 25 years) Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Primary Change in Psychosocial Functioning- The Psychosocial Functioning Inventory (PFI) The Psychosocial Functioning Inventory (PFI) will be used to measure social functioning. The social behavior sub-scale will be calculated from 10 items of the PFI and included items that assess the frequency of problematic social behavior and social interactions in the past 90 days. The psychosocial functioning scale yields a score ranging from 0-100, with higher scores indicating greater impairment. Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Primary Change in Psychosocial Functioning- World Health Organization (WHO)-Quality of Life WHO-Quality of Life brief assessment (BREF) will be used to measure the four domains of quality of life: (1) physical health; (2) psychological (3) social relationships; and (4) environment (26 items). Each item in the WHOQOL-BREF will be scored with a 5-point Likert scale (three items are reverse scored), and these scores will be used to generate raw scores for each domain, which will be then scaled 0-100, with higher scores indicating greater quality of life. Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Primary Change in Psychosocial Functioning- Satisfaction with Life and social Functioning Satisfaction with life and social functioning over the past 90 days will be assessed using 4 questions: How happy have you been (1) with life?; (2) with your living situation? and (3) with your relationships? and (4) Did you feel satisfied with leisure, social, and recreational activities? (0 = satisfied/happy; 1 = dissatisfied/unhappy) Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Primary Change in Psychosocial Functioning- Career Engagement Engagement in proactive career behaviors over time (9 items). Each item in the career engagement measure will be scored with the 5-point Likert-type scale. The average scale scores will range between 1-5 with higher score indicating greater engagement. Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Primary Change in Psychosocial Functioning- Addiction Severity The Addiction Severity Index (ASI) will be used to assess experiences of serious depression, serious anxiety or tension, and cognitive difficulty (i.e., trouble understanding, concentrating, or remembering) in the past 90 days. All items will be binary indicators, where 0 = employed or symptom not present and 1 = unemployed or symptom present. Items will be examined individually. Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Primary Change in Substance Use- SUD Status and Severity The Diagnostic and Statistical Manual-5 (DSM-5) SUD (last year & last 3 months) will be used to assess SUD status and severity with mild, moderate, and severe sub-classifications Approximately every 3 months from date of baseline session through study completion, an average of 3 years
Primary Change in Substance Use- Consumption Timeline Follow Back-90 (TLFB-90) will be used to obtains retrospective daily estimates of substance use in the last 3 month. TLFB can generate a variety of variables that provide more precise and varied information (e.g., pattern, variability) about a person's substance use Approximately every 3 months from date of baseline session through study completion, an average of 3 years
See also
  Status Clinical Trial Phase
Completed NCT05660434 - Using Aromatherapy in Substance Use Disorder N/A
Active, not recruiting NCT05338268 - Substance Use and Loneliness N/A
Completed NCT03954184 - E-health Implementation (Iowa) N/A
Completed NCT04098614 - Barriers to Substance Use Disorder Recovery N/A
Completed NCT03590106 - Cardiac Surgery Peer Recovery Support Program N/A
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Recruiting NCT05327504 - Written Exposure Therapy for Veterans With SUD and PTSD N/A
Terminated NCT03517111 - The Impact of a Parenting Intervention on Latino Youth Health Behaviors N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT04401215 - Technologically-Augmented Referrals to Mitigate Addiction Consequences N/A
Not yet recruiting NCT06187701 - Co-Active Therapeutic Theatre (Co-ATT) for Dual-Diagnosis Patients N/A
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A
Recruiting NCT04296604 - Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations N/A
Active, not recruiting NCT02382042 - Intensive Referral Intervention to Improve Substance Use Disorder Treatment Outcomes Among Rural and Highly Rural Veterans N/A
Completed NCT01237366 - Study Targeting Affect Regulation Phase 1/Phase 2
Terminated NCT01356667 - Drum-Assisted Therapy for Native Americans N/A
Completed NCT00708890 - Twelve Step Based Self-help Groups for Substance Related Disorders N/A
Active, not recruiting NCT04048850 - Zepatier in Patients With Substance Use
Recruiting NCT05976646 - Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion Phase 1/Phase 2