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

Recruiting
Conditions
Alcohol Use Disorder
Interventions
Other: Online survey
Registration Number
NCT04788004
Lead Sponsor
Virginia Polytechnic Institute and State University
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.

Detailed Description

The study will characterize long-term trajectories of recovery from alcohol use including the associated changes in psychosocial functioning and relapse status. By using an accelerated longitudinal design, competing neurobehavioral decision systems (CNDS) functioning (measured using delay discounting), psychosocial functioning, and relapse will be characterized over a 12-year period for individuals in alcohol use disorder (AUD) recovery.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
682
Inclusion Criteria
  1. be ≥18 yrs old
  2. meet lifetime DSM-5 AUD criteria
  3. have a Recovery Initiation Date less than 10 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)
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Exclusion Criteria
  • 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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Cohort 2Online surveyParticipants in this group started their recovery process 1 to \<2 years ago
Cohort 4Online surveyParticipants in this group started their recovery process 3 to \<4 years ago
Cohort 3Online surveyParticipants in this group started their recovery process 2 to \<3 years ago
Cohort 5Online surveyParticipants in this group started their recovery process 4 to \<5 years ago
Cohort 6Online surveyParticipants in this group started their recovery process 5 to \<6 years ago
Cohort 10Online surveyParticipants in this group started their recovery process 9 to \<10 years ago
Cohort 1Online surveyParticipants in this group started their recovery process \< 1 year ago
Cohort 8Online surveyParticipants in this group started their recovery process 7 to \<8 years ago
Cohort 9Online surveyParticipants in this group started their recovery process 8 to \<9 years ago
Cohort 7Online surveyParticipants in this group started their recovery process 6 to \<7 years ago
Primary Outcome Measures
NameTimeMethod
Psychosocial Functioning- Career EngagementApproximately 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.

Alcohol Use- AUD Status and SeverityApproximately every 3 months from date of baseline session through study completion, an average of 3 years

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

Alcohol Use- ConsumptionApproximately 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 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

CNDS functioningApproximately 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)

Adverse Social and emotional eventsApproximately every 3 months from date of baseline session through study completion, an average of 3 years

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)

Psychosocial Functioning- The Psychosocial Functioning Inventory (PFI)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.

Psychosocial Functioning- World Health Organization (WHO)-Quality of LifeApproximately 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.

Psychosocial Functioning- Satisfaction with Life and social FunctioningApproximately 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)

Psychosocial Functioning- Addiction SeverityApproximately 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Fralin Biomedical Research Institute at VTC

🇺🇸

Roanoke, Virginia, United States

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