The Longitudinal Impact of SES and the CNDS on Recovery From SUD

April 11, 2024 updated by: Warren K. Bickel, Virginia Polytechnic Institute and State University

The Longitudinal Impact of Socioeconomic Status and the Competing Neurobehavioral Decision Systems on Recovery From Substance Use Disorder

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

675

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Warren K Bickel, PhD
  • Phone Number: 540-526-2088
  • Email: wkbickel@vt.edu

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals in recovery from SUD who meets the study inclusion criteria will be recruited from The International Quit & Recovery Registry (IQRR) (https://quitandrecovery.org). Participants will be recruited from existing or new IQRR registrants; that is, IQRR registrants meeting the inclusion criteria (see above) will be invited to participate. Also, the recruitment of new registrants will use methods designed to reflect the heterogeneity of the recovery population.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
Participants in this group started their recovery process < 1 year ago
Other: Online Survey
There are no interventions planned for this study. This is an observational study only.
Cohort 2
Participants in this group started their recovery process 1 to <2 years ago
Other: Online Survey
There are no interventions planned for this study. This is an observational study only.
Cohort 3
Participants in this group started their recovery process 2 to <3 years ago
Other: Online Survey
There are no interventions planned for this study. This is an observational study only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Socioeconomic Status (SES)- Individual Subjective SES
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
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
Change in Socioeconomic Status (SES)- Individual Objective SES
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
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
Change in CNDS functioning
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
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
Change in Psychosocial Functioning- The Psychosocial Functioning Inventory (PFI)
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
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
Change in Psychosocial Functioning- World Health Organization (WHO)-Quality of Life
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
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
Change in Psychosocial Functioning- Satisfaction with Life and social Functioning
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
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
Change in Psychosocial Functioning- Career Engagement
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
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
Change in Psychosocial Functioning- Addiction Severity
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
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
Change in Substance Use- SUD Status and Severity
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
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
Change in Substance Use- Consumption
Time Frame: Approximately every 3 months from date of baseline session through study completion, an average of 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Polytechnic Institute and State University

Investigators

  • Principal Investigator: Warren Bickel, PhD, Virginia Polytechnic Institute and State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (Actual)

November 2, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SES- Longitudinal Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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