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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-20

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Alcoholism Alcohol Drinking Drinking Behavior Alcohol-Related Disorders Substance-Related Disorders Mental Disorder Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Amplification of Positivity for Alcohol Use Disorders (AMP-A; 12 sessions)

Group Type EXPERIMENTAL

Amplification of Positivity Training

Intervention Type BEHAVIORAL

12 90-minute, clinician-administered treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) designed to increase positive emotions, cognitions, and behaviors.

Cognitive-behavioral Therapy (CBT; 12 sessions)

Group Type ACTIVE_COMPARATOR

Cognitive-behavioral Therapy

Intervention Type BEHAVIORAL

12 90-minute, clinician-administered treatment sessions focused on strategies to alter cognitions and behavior related to alcohol use.

Interventions

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Amplification of Positivity Training

12 90-minute, clinician-administered treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) designed to increase positive emotions, cognitions, and behaviors.

Intervention Type BEHAVIORAL

Cognitive-behavioral Therapy

12 90-minute, clinician-administered treatment sessions focused on strategies to alter cognitions and behavior related to alcohol use.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No