Amplification of Positivity for Alcohol Use

NCT06030154 | Recruiting DMC

• 2 other identifiers: 2022-003R34AA030688
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Alcohol Use Disorder; Anxiety; Depression

Outcome Measures

Primary Outcomes (3)

• 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.

  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)

• 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.

  Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)

• 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.

  Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)

Secondary Outcomes (7)

• Distress/Endorsement Validation Scale (DEVS)

  Average of total scores from the following time points:2 weeks after starting treatment, post-treatment (average of 16 weeks after baseline assessment)

• Change in Average drinks per drinking day

  Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale

  Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale

  Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)

• Change in Sheehan Disability Scale (SDS)

  Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)

Study Arms (2)

Amplification of Positivity Therapy

EXPERIMENTAL

AMP-A will involve 12, one-hour weekly therapy sessions completed one-on-one with a therapist. The sessions and between-session homework will focus on amplifying positive thoughts, emotions, and behaviors to address anxiety/depression and alcohol use.

Behavioral: Amplification of Positivity Therapy; Behavioral: Surveys and Interviews

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

The CBT intervention will involve 12, one-hour weekly therapy sessions completed one-on-one with a therapist. The sessions and between-session homework will focus on monitoring of the relationship between thoughts, emotions, and alcohol use.

Behavioral: Cognitive Behavioral Therapy; Behavioral: Surveys and Interviews

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

Cognitive Behavioral Therapy

Cognitive Behavioral Therapy

Amplification of Positivity Therapy BEHAVIORAL

Amplification of Positivity Therapy

Amplification of Positivity Therapy

Surveys and Interviews BEHAVIORAL

Participants will answer questions regarding their mental and physical health as well as their substance use on the computer and in an interview format.

Amplification of Positivity Therapy; Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Below normative levels of positive affect as indexed by PROMIS Positive Affect \<50.
• Able to provide written informed consent.
• Have sufficient proficiency in the English language to understand and complete interviews, questionnaires, and all other study procedures.

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). 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.
• 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 drugs of abuse, including alcohol (breath test) and substances of dependence that are not physician prescribed (i.e., cocaine, cannabis, opioids, stimulants).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.
• Taking drugs that affect the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, and excessive caffeine intake \> 1000 mg/day) - Phase 2 only
• 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.
• MRI contraindications (for those in Phase 2 opting into this portion) including: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a professional metal worker/welder, history of eye surgery/eyes washed out because of metal, vision problems uncorrectable with lenses, inability to lie still on one's back for 60-120 minutes; prior neurosurgery; tattoos or cosmetic makeup with metal dyes, unwillingness to remove body piercings, and pregnancy - Phase 2 only
• 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 licensed clinician determination of American Society of Addiction Medicine (ASAM) Criteria ≥ 0-1 across dimensions, with the exception of a '2' on the emotional dimension.
• Given the current study involves development of the positive affect intervention, we will not enroll any special vulnerable populations (pregnant women, fetuses, neonates, prisoners, children).

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead
• University of California, San Diego: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74008, United States

RECRUITING

Related Publications (3)

• Akeman E, White E, Wolitzky-Taylor K, Santiago J, McDermott TJ, DeVille DC, Stewart JL, Paulus M, Taylor CT, Aupperle RL. Amplification of Positivity Therapy for Co-occurring Alcohol Use Disorder with Depression and Anxiety Symptoms: Pilot Feasibility Study and Case Series. Behav Modif. 2022 Sep;46(5):1021-1046. doi: 10.1177/01454455211030506. Epub 2021 Jul 12.

  PMID: 34253077 BACKGROUND

• 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.

  PMID: 28060463 BACKGROUND

• Kryza-Lacombe M, Pearson N, Lyubomirsky S, Stein MB, Wiggins JL, Taylor CT. Changes in neural reward processing following Amplification of Positivity treatment for depression and anxiety: Preliminary findings from a randomized waitlist controlled trial. Behav Res Ther. 2021 Jul;142:103860. doi: 10.1016/j.brat.2021.103860. Epub 2021 Apr 15.

  PMID: 33894554 BACKGROUND

MeSH Terms

Conditions

Alcoholism; Anxiety Disorders; Depression

Interventions

Cognitive Behavioral Therapy; Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Robin L Aupperle, PhD

  Laureate Institute for Brain Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin L Aupperle, PhD

CONTACT

918-502-5155; neurocatt@laureateinstitute.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: September 8, 2023
• Study Start: September 25, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 6 months of the start of the award, the investigators will complete the Data Submission Agreement and Data Expected aspects of this project within NIAAADA, with the first project data uploaded to NDA within one year of the start of the award, in accordance with applicable Data Sharing Terms and Conditions of the award. The investigators will perform QA/QC checks on data within 4 months after the submission due date and address any identified issues. Data will then be cumulatively every 6 months throughout the project.

Locations

US (1)