Affective Modulation of Positivity for Alcohol Use Disorder

NCT04278365 | Completed

• 1 other identifier: 2019-010
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Anxiety; Depression; Alcohol Use Disorder

Keywords

Psychological

Outcome Measures

Primary Outcomes (3)

• 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.

  Post-intervention (within approximately 2 weeks after completing intervention)

• 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.

  Post-intervention (within approximately 2 weeks after completing intervention)

• Completion rate

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

  Post-intervention (within approximately 2 weeks after completing intervention)

Secondary Outcomes (8)

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

  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)

• Change in Alcohol Craving Questionnaire

  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)

• Change in Positive and Negative Affect Schedule (PANAS)

  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)

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

  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)

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

  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 (2)

• Change in striatal responses during reward processing

  Post-intervention (within approximately 2 weeks after completing intervention)

• Change in striatal responses during alcohol cue processing

  Post-intervention (within approximately 2 weeks after completing intervention)

Study Arms (1)

AMP-A

EXPERIMENTAL

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

Positive affect training BEHAVIORAL

Behavioral training involving position emotion enhancement

Also known as: Affective Modulation of Positivity (AMP)

AMP-A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

Related Publications (2)

• 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

• 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 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Alcoholism

Condition Hierarchy (Ancestors)

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

Study Officials

• Robin Aupperle, PhD

  Laureate Institute for Brain Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: October 16, 2019
• Primary Completion: March 26, 2020
• Study Completion: June 19, 2020
• Last Updated: September 1, 2020

Record last verified: 2020-03

Locations

US (1)