Amplification of Positivity for Alcohol Use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLaureate Institute for Brain Research, Inc.
About this trial
The proposed study consists of two phases. During Phase 1, the investigators will recruit a small sample of participants to complete a psychosocial intervention termed Amplification of Positivity (AMP) for individuals experiencing comorbid depression or anxiety disorders and alcohol use disorder (AMP-A). These participants will be asked to provide both qualitative and quantitative input about the AMP-A intervention. Based on their input and clinician input, the AMP-A manual will be modified for use in Phase 2. The goal is to recruit up to 20 participants in order to ensure there will be at least 8 participants who complete all sessions of AMP-A. Phase 2 is a randomized clinical trial (RCT) protocol in which individuals experiencing comorbid depression or anxiety disorders and alcohol use disorder will be randomized to complete AMP-A or an evidence-based cognitive-behavioral therapy (CBT) intervention. Up to 100 participants will be recruited in order to reach a target of N=60. 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, functional disability, and neural reactivity to reward and alcohol cues during functional magnetic resonance imaging (fMRI).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 65 years old.
Meeting diagnostic criteria for alcohol use disorder 42 according to the DSM-5.
Reports that they would like to seek treatment for AUD and that AUD is one of the primary challenges they would like to address in treatment.
Phase 1: 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. Phase 2: Significant depression or anxiety symptoms as indexed by scoring ≥ 55 on either of the NIH PROMIS ((Patient-Reported Outcomes Measurement Information System) Depression and/or Anxiety scales.
Disqualifiers
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). In addition, the neuroimaging portion of the protocol will be optional.
Non-correctable vision or hearing problems that interfere with the participant's ability to complete study assessments.
No telephone or easy access to telephone.
Diagnosis of Schizophrenia spectrum, other psychotic disorders, obsessive-compulsive disorder, eating disorders, substance use disorders within the past year other than alcohol use disorder or cannabis use disorder, or bipolar I disorder. Mild binge eating disorder will be considered for inclusion on a case-by-case basis at the discretion of the PI.
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy
BehavioralCognitive Behavioral Therapy
Amplification of Positivity Therapy
BehavioralAmplification of Positivity Therapy
Surveys and Interviews
BehavioralParticipants will answer questions regarding their mental and physical health as well as their substance use on the computer and in an interview format.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Amplification of Positivity TherapyExperimental treatment 2 interventions
Group B: Cognitive Behavioral TherapyActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Perceived acceptability and satisfaction of the intervention as measured with the Adherence and Acceptability Scale (AAS)
This measure assesses the acceptability and tolerability of the intervention and is the primary outcome for Phase 1. Scores may range from 10 to 70, with higher scores indicating greater acceptability of treatment and greater anticipated ability to adhere to it.
Time frame
Average of total scores from the following time points: pre-treatment, 2 weeks after starting treatment, 6 weeks after starting treatment, and at post-treatment (average of 16 weeks after baseline assessment)2
Change in positive affect self-report measured with National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Positive Affect score
National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Positive Affect Scale, which is reported as a T score. The score is presented as a T score with a mean of 50 and a standard deviation of 10, with a range of 0-100. Higher scores indicate greater positive affect or better outcome. This is a primary outcome for Phase 2.
Time frame
Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)3
Change in number of drinking days in the past month
As measured through self-reported drinking days using Timeline Followback. This is a primary outcome for Phase 2.
Time frame
Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)Secondary outcomes
1
Distress/Endorsement Validation Scale (DEVS)
This measure assesses two factors, distress (7 items) and endorsement (3 items) and is a secondary outcome for Phase 1. The distress subscale score ranges from 7 to 63, with higher scores indicating more distress experienced during the intervention. The endorsement subscale ranges from 3 to 27, with higher scores indicating greater endorsement of the intervention.
Time frame
Average of total scores from the following time points:2 weeks after starting treatment, post-treatment (average of 16 weeks after baseline assessment)2
Change in Average drinks per drinking day
As measured through self-reported drinks using a Timeline Followback interview. This is a secondary outcome for Phase 2.
Time frame
Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)3
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
This measure assesses symptoms of anxiety over the past 7 days. The score is presented as a T score with a mean of 50 and standard deviation of 10, with a range of 0-100. Higher scores indicating greater symptoms of anxiety. This is a secondary outcome for Phase 2.
Time frame
Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)4
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale
This measure assesses symptoms of depression over the past 7 days. The score is presented as a T score with a mean of 50 and standard deviation of 10, with a range of 0-100. Higher scores indicating greater symptoms of depression. This is a secondary outcome for Phase 2.
Time frame
Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Laureate Institute for Brain Research, Inc.
Lead sponsor
University of California, San Diego
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov