Clinical trial NCT04934553: Amplification of Positivity for Alcohol Use Disorder Co-Occurring With Anxiety or Depression
Official title: Amplification of Positivity for Alcohol Use Disorder (AMP-A): Feasibility and Pilot Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorder
Anxiety
Depression
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Laureate Institute for Brain Research, Inc.
First posted: 2021-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adherence and Acceptability Scale (AAS)
timeFrame: Post intervention (approximately 2 weeks after completing intervention)
measure: Distress/Endorsement Validation Scale (DEVS)
timeFrame: Post intervention (approximately 2 weeks after completing intervention)
measure: Completion rate
timeFrame: Post intervention (approximately 2 weeks after completing intervention)
Secondary outcomes:
measure: Change from baseline in well-being as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect and Well-being Scale
timeFrame: Baseline, Primary Endpoint: Post-treatment (i.e., within two weeks of completing the intervention), Secondary Endpoints: Three month follow-up (i.e., 12-15 weeks after completing the intervention)
measure: Change from baseline in alcohol craving as measured by the Alcohol Craving Questionnaire (ACQ)
timeFrame: Baseline, Primary Endpoint: Post-treatment (i.e., within two weeks of completing the intervention), Secondary Endpoints: Three month follow-up (i.e., 12-15 weeks after completing the intervention)
measure: Change from baseline in positive affect as measured by Positive and Negative Affect Schedule
timeFrame: Baseline, Primary Endpoint: Post-treatment (i.e., within two weeks of completing the intervention), Secondary Endpoints: Three month follow-up (i.e., 12-15 weeks after completing the intervention)
measure: Change from baseline in anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
timeFrame: Baseline, Primary Endpoint: Post-treatment (i.e., within two weeks of completing the intervention), Secondary Endpoints: Three month follow-up (i.e., 12-15 weeks after completing the intervention)
measure: Change from baseline in depression as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale
timeFrame: Baseline, Primary Endpoint: Post-treatment (i.e., within two weeks of completing the intervention), Secondary Endpoints: Three month follow-up (i.e., 12-15 weeks after completing the intervention)
measure: Change from baseline in level of functional disability as measured by the Sheehan Disability Scale (SDS)
timeFrame: Baseline, Primary Endpoint: Post-treatment (i.e., within two weeks of completing the intervention), Secondary Endpoints: Three month follow-up (i.e., 12-15 weeks after completing the intervention)
measure: Change from baseline in alcohol use
timeFrame: Baseline, Primary Endpoint: Post-treatment (i.e., within two weeks of completing the intervention), Secondary Endpoints: Three month follow-up (i.e., 12-15 weeks after completing the intervention)
measure: Change from baseline in pleasure experience as measured by the Snaith-Hamilton Please Scale (SHAPS)
timeFrame: Baseline, Primary Endpoint: Post-treatment (i.e., within two weeks of completing the intervention), Secondary Endpoints: Three month follow-up (i.e., 12-15 weeks after completing the intervention)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Altman Clinical and Translational Research Institute
state: California
city: Tulsa
country: United States
facility: Laureate Institute for Brain Research
state: Oklahoma
Study officials:
affiliation: Altman Clinical and Translational Research Institute
name: Charles T Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laureate Institute for Brain Research
name: Robin Aupperle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taylor CT, Lyubomirsky S, Stein MB. Upregulating the positive affect system in anxiety and depression: Outcomes of a positive activity intervention. Depress Anxiety. 2017 Mar;34(3):267-280. doi: 10.1002/da.22593. Epub 2017 Jan 6.