Long-term Recovery: Longitudinal Study of Neuro-behavioral Markers of Recovery and Precipitants of Relapse

NCT04788004 | Active Not Recruiting

• 1 other identifier: IQRR- Longitudinal Study
• Study Type: observational
• Target: 733
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this study are to provide a scientific understanding of recovery and relapse, as well as to identify novel targets for future relapse prevention interventions.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• Alcohol Use- AUD Status and Severity

  The Diagnostic and Statistical Manual-5 (DSM-5) AUD (last year \& last 3 months) will be used to assess AUD 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

• Alcohol Use- Consumption

  Timeline Follow Back-90 (TLFB-90) will be used to obtains retrospective daily estimates of alcohol consumption in the last 3 month. TLFB can generate a variety of variables that provide more precise and varied information (e.g., pattern, variability, drinking levels) about a person's drinking

  Approximately every 3 months from date of baseline session through study completion, an average of 3 years

• Adverse Social and emotional events

  Inventory of Drug Taking Situations (IDTS-8) will be used to assess the frequency of common relapse-inducing events (i.e., negative affect, social pressure, physical discomfort, and drinking-related variables such as temptations, urges, and alcohol cues; 8 items)

  Approximately every 3 months from date of baseline session through study completion, an average of 3 years

Study Arms (10)

Cohort 1

Participants in this group started their recovery process \< 1 year ago

Other: Online survey

Cohort 2

Participants in this group started their recovery process 1 to \<2 years ago

Other: Online survey

Cohort 3

Participants in this group started their recovery process 2 to \<3 years ago

Other: Online survey

Cohort 4

Participants in this group started their recovery process 3 to \<4 years ago

Other: Online survey

Cohort 5

Participants in this group started their recovery process 4 to \<5 years ago

Other: Online survey

Cohort 6

Participants in this group started their recovery process 5 to \<6 years ago

Other: Online survey

Cohort 7

Participants in this group started their recovery process 6 to \<7 years ago

Other: Online survey

Cohort 8

Participants in this group started their recovery process 7 to \<8 years ago

Other: Online survey

Cohort 9

Participants in this group started their recovery process 8 to \<9 years ago

Other: Online survey

Cohort 10

Participants in this group started their recovery process 9 to \<10 years ago

Other: Online survey

Interventions

Online survey OTHER

There are no interventions planned for this study. This is an observational study only.

Cohort 1; Cohort 10; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8; Cohort 9

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals in recovery from AUD 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.

You may qualify if:

• be ≥18 yrs old
• meet lifetime DSM-5 AUD criteria
• have a Recovery Initiation Date less than 10 years prior to the time of enrollment
• be able to read independently
• be free of legal problems that could limit participation
• reside in the U.S.
• anticipate continued Internet access (to ensure ongoing contact and data collection)
• be a registrant of the International Quit and Recovery Registry (IQRR)

You may not qualify if:

• Minors will not be included
• 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 incarcerations ends during the study, they may be contacted to participate in assessments.
• Adults who are not capable of consenting on their own behalf

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jungmeen Kim-Spoon, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

• Allison Tegge, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 9, 2021
• Study Start: September 8, 2022
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (1)