Amplification of Positivity for Alcohol Use Disorder Co-Occurring With Anxiety or Depression

Paused · Not applicable

Conditions studied: Alcoholism, Alcohol Drinking, Drinking Behavior, Alcohol-Related Disorders, Substance-Related Disorders, Mental Disorder, Anxiety, Depression

In brief

The purpose of this study is to examine the feasibility of a protocol in which individuals with comorbid depression or anxiety disorders and alcohol use disorder will be randomized to complete Amplification of Positivity for Alcohol Use Disorder (AMP-A)- a psychological treatment focused on increasing positive thoughts, emotions, and behaviors- or a traditional cognitive-behavioral therapy (CBT) intervention. Assessed outcomes will include participant acceptability and completion rates, participant compliance with the intervention, positive and negative affect, substance use- and depression and anxiety-related symptom severity, and functional disability.

Key facts

Study ID

NCT04934553

Run by

Charles Taylor

People needed

20

Starts

2021-05-20

Expected to finish

2023-06-01

Last updated by the study team

2022-04-20

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 18 and 55 years old.
• Meet diagnostic criteria for alcohol use disorder according to the DSM-5
• Significant depression or anxiety symptoms as indexed by scoring Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8.
• Able to provide written informed consent.
• Have sufficient proficiency in the English language to understand and complete interviews, questionnaires, and all other study procedures.
• Completion of at least an 8th grade education, to help facilitate ability to engage in the written materials included in the treatments.

You may not qualify if…

• Unwillingness or inability to complete any of the major aspects of the study protocol, including self-report or behavioral assessment. However, failing to complete some individual aspects of these assessment sessions will be acceptable (i.e., being unwilling to answer individual items on some questionnaires or being unwilling to complete a behavioral task).
• Non-correctable vision or hearing problems.
• No telephone or easy access to telephone.
• Diagnosis of Schizophrenia spectrum, other psychotic disorders, or bipolar I disorder.
• Active suicidal ideation with plan and intent to attempt suicide within the next month.
• Has a history of unstable liver or renal insufficiency; glaucoma; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
• A positive test for alcohol (breath test) at the time of baseline assessments. Participants will be asked to refrain from using alcohol within 24 hours prior to assessment sessions and to refrain from using marijuana within 48 hours of assessment sessions.
• Initiation of a new psychotropic medication (e.g., SSRIs) or change in the dose or prescription of a medication within the 6 weeks prior to enrolling in the study.
• Concurrent engagement in psychosocial treatments that specifically target alcohol use disorder or mood/anxiety symptoms and began within 12 weeks of baseline assessments. Individuals concurrently receiving psychosocial treatments for other symptoms, or that are not specifically targeting symptoms (e.g., ongoing support groups) will not be excluded as long as the dose of treatment (i.e., frequency of sessions) has not changed significantly within 6 weeks prior to enrolling in the study.
• Moderate to severe traumatic brain injury (>30 min. loss of consciousness or >24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits, neurological disorders, or severe or unstable medical conditions that might be compromised by participation in the study (to be determined by primary care provider).
• Severity of alcohol use disorder requiring more intensive treatment (i.e., intensive outpatient or residential), as determined by baseline assessments conducted by clinicians.

Where it is running

• Altman Clinical and Translational Research Institute — La Jolla, California, United States
• Laureate Institute for Brain Research — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.