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CompletedNCT04278365AMP-AUpdated Sep 1, 2020

Affective Modulation of Positivity for Alcohol Use Disorder

An interventional study of Positive affect training in Anxiety, Depression and Alcohol Use Disorder, sponsored by Laureate Institute for Brain Research, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-09-01.

Sponsored by Laureate Institute for Brain Research, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Oct 2019, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The proposed study is a pilot study examining the feasibility and potential utility of administering a psychosocial intervention termed Affective Modulation of Positivity (AMP) for individuals suffering from co-morbid depression or anxiety disorders and alcohol use disorder (AMP-A). The aims of this study are to (1) determine the feasibility and potential utility of administering AMP-A with individuals suffering from alcohol use disorders, (2) explore the potential impact of training on positive and negative affect, symptom severity, and functional disability, and (3) explore the potential impact of training on neural reactivity to reward and alcohol cues during functional magnetic resonance imaging (fMRI).

Read the detailed description

This study is a non-randomized, single-arm, single-site clinical trial conducted at Laureate Institute for Brain Research (LIBR) in Tulsa, OK. The primary objective for this study is to examine the feasibility and acceptability of conducting positive affect training with individuals suffering from substance use disorder. Primary outcome will include treatment completion rate; secondary outcome will include the score on a participant feedback questionnaire. The investigators hypothesize that the majority of participants (>60%) will complete all 11 sessions of the intervention and that participant feedback concerning the intervention will be at least moderately favorable on average.The secondary objective(s) is to explore the potential impact of training on positive and negative affect, symptom severity, and functional disability. The investigators hypothesize that positive affect will significantly increase from baseline to post-intervention, while negative affect, alcohol-related craving, and functional disability will significantly decrease. A tertiary objective is to explore the potential impact of training on behavioral and neural responses involving the processing of positively valenced or alcohol-related cues. The investigators hypothesize that activation with striatal and orbitofrontal cortex (OFC) regions to alcohol-UNrelated reward cues will increase from baseline to post-intervention, while striatal and OFC response to alcohol-related cues will decrease from baseline to post-intervention.

Participants will be asked to complete interview and pencil-and-paper questionnaires related to clinical symptoms, traits and personality characteristics, daily life function, and medical and mental health history at both pre- and post-intervention. Participants will also be asked to complete brief follow-up survey sessions 3 months after completing treatment. If there are participants who are only able to complete part of the intervention (i.e., only able to attend a few of the sessions) either due to their own wish to terminate or due to exclusion criteria or clinical concerns, they will only be asked to complete survey sessions for weeks that they attend. Neuroimaging procedures will be conducted at both pre- and post-intervention. Each neuroimaging session will last approximately 1.5-2.5 hours and will involve completion of self-report measures regarding current affective state and sleepiness and a functional MRI session during which participants will complete tasks related to reward processing and alcohol cue reactivity.

Following completion of baseline assessments, participants will be asked to complete 11 sessions of the positive affect intervention, conducted once or twice weekly and with each session lasting 1 - 1.5 hours. If the content of sessions is too much to cover for any one client, the intervention may be extended to 13 sessions as needed. Participants will be expected to complete all intervention sessions within 16 weeks of starting the first session. Each session will be completed as individual therapy sessions (i.e., one-on-one with a therapist). The positive affect intervention will involving positive emotion enhancement exercises established in prior studies, including noticing and amplifying positive emotions, practicing gratitude, engaging in acts of kindness, and pleasurable or meaningful activities, identifying strengths and values, being optimistic, engaging in activities meant to make others happy, and living life to its fullest. The investigators will use the protocol developed by Taylor et al. with modifications to specifically address alcohol use, based on previous work. The general structure of each session will follow standard cognitive behavioral treatment regimens as follows: (1) meet with clinician to review completion of the prior week's exercises, including self-monitoring forms of emotions and exercise completion; (2) identify and troubleshoot any issues that arose during exercise completion; (3) introduce material about a new positive emotion enhancement activity; (4) identify concrete exercises to implement for the upcoming week.

02

Conditions studied

  • Anxiety
  • Depression
  • Alcohol Use Disorder

Keywords

  • Psychological
03

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 8 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Laureate Institute for Brain Research, Inc. is the lead sponsor of 53 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Age between 18 and 55 years old.
  2. Meeting diagnostic criteria for alcohol use disorder 41 according to the DSM-5.
  3. 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.
  4. Able to provide written informed consent.
  5. Have sufficient proficiency in the English language to understand and complete interviews, questionnaires, and all other study procedures.
  6. Completion of at least an 8th grade education, to help facilitate ability to engage in the written materials included in the Positive Affect Training.

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. 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).
  2. Non-correctable vision or hearing problems.
  3. No telephone or easy access to telephone.
  4. Diagnosis of Schizophrenia spectrum, other psychotic disorders, or bipolar I disorder.
  5. Active suicidal ideation with plan and intent to attempt suicide within the next month.
  6. 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.
  7. A positive test for drugs of abuse, including alcohol (breath test), cocaine, marijuana, opiates, amphetamines, methamphetamines, phencyclidine, benzodiazepines, barbiturates, methadone, and oxycodone 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.
  8. Current use of a medication or change in the dose or prescription of a medication within the 6 weeks prior to enrolling in the study that could potentially affect brain functioning (e.g., stimulants, anxiolytics, antipsychotics, mood stabilizers, anti-hypertensives). The current use of antidepressants (i.e., SSRIs) will not be excluded as long as the dose has remained consistent for 6 weeks prior to baseline assessment sessions. While individuals reporting use of benzodiazepines will be excluded; individuals with sporadic use (i.e., less than once per week) may be included, but will be asked to refrain from using within 72 hours prior to assessment sessions. Inclusion of individuals reporting other types of medications or supplements not listed or considered this far will be at the discretion of the PI according to evidence in the literature of it affecting brain function or brain blood flow.
  9. Taking drugs that affect the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, and excessive caffeine intake > 1000 mg/day).
  10. 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.
  11. MRI contraindications 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.
  12. 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).
  13. Severity of alcohol use disorder requiring more intensive treatment (i.e., intensive outpatient or residential), as determined by baseline assessments conducted by licensed clinicians.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    AMP-A

    Participants will complete 11, 90-minute sessions of positive affect training. The positive affect training will be conducted in an individual setting. Positive affect training directly targets reward and positive valence processing and has been shown by previous research to enhance positive affect (and decrease negative affect).

    Behavioral: Positive affect training

Interventions

  • BehavioralPositive affect training

    Behavioral training involving position emotion enhancement

    Also known as: Affective Modulation of Positivity (AMP)

06

What researchers measure

Primary outcomes

  1. Adherence and Acceptability Scale (AAS)

    This measure assesses the acceptability and tolerability of the intervention. 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: Post-intervention (within approximately 2 weeks after completing intervention)

  2. Distress/Endorsement Validation Scale (DEVS)

    This measure assesses two factors, distress (7 items) and endorsement (3 items). 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: Post-intervention (within approximately 2 weeks after completing intervention)

  3. Completion rate

    Completion rate assessed as whether or not the participant completes all 11 sessions of intervention

    Time frame: Post-intervention (within approximately 2 weeks after completing intervention)

Secondary outcomes

  1. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect and Well-being Scale

    This measure assesses positive or rewarding affective experiences over the past 7 days. The score is presented as a T score with a mean of 50 and standard deviation of 10, with higher scores indicating greater positive affect and well-being.

    Time frame: 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)

  2. Change in Alcohol Craving Questionnaire

    This measure assesses four dimensions of alcohol craving. A total score ranges from 1-12, with higher scores indicating higher levels of alcohol craving.

    Time frame: 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)

  3. Change in Positive and Negative Affect Schedule (PANAS)

    This measure assesses factors related to positive and negative affect. Each of these factor scores range rom 10 to 50, with higher score indicates greater levels of positive and negative affect, respectively.

    Time frame: 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)

  4. 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 higher scores indicating greater symptoms of anxiety.

    Time frame: 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)

  5. 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 higher scores indicating greater symptoms of depression.

    Time frame: 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)

  6. Change in Sheehan Disability Scale

    This measures assesses level of functional disability. Total score ranges from 0-30, with higher scores indicating greater impairment.

    Time frame: 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)

  7. Change in alcohol use

    As measured by self-reported drinks per day

    Time frame: 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)

  8. Change in Snaith-Hamilton Please Scale (SHAPS)

    This measure assesses the ability to experience pleasure. Total scores range from 0 to 14, with a higher score indicating higher levels of anhedonia.

    Time frame: 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

  1. Change in striatal responses during reward processing

    Reward processing as measured by MID task

    Time frame: Post-intervention (within approximately 2 weeks after completing intervention)

  2. Change in striatal responses during alcohol cue processing

    Alcohol cue processing as measured by alcohol cue task

    Time frame: Post-intervention (within approximately 2 weeks after completing intervention)

07

Study locations

1 site
  • Laureate Institute for Brain Research
    Tulsa, Oklahoma 74136, United States
08

References and documents

Publications

  • 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. PubMed 28060463 ↗
  • 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. PubMed 34253077 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04278365
Lead sponsor
Laureate Institute for Brain Research, Inc.
Responsible party
Sponsor
First posted
Feb 20, 2020
Start date
Oct 16, 2019
Primary completion
Mar 26, 2020
Completion
Jun 19, 2020
Last update
Sep 1, 2020

Study contacts

Robin Aupperle, PhD
principal investigator · Laureate Institute for Brain Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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