AzTrials
AzTrials

AnxietyAMP-ANCT04278365

Affective Modulation of Positivity for Alcohol Use Disorder

A study testing Positive affect training in people with Anxiety and Depression, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Anxiety, Depression, Alcohol Use Disorder
What is being tested?
Positive affect training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
16 Oct 2019to 19 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Laureate Institute for Brain Research

    Tulsa, Oklahoma, 74136

Other trials in United States

About this study

Official title: Affective Modulation of Positivity for Alcohol Use Disorder (AMP-A): Feasibility and Pilot Study

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.

Being tested
Positive affect training
Keywords
Psychological
Medical subject headings
Anxiety Disorders, Depression, Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Positive affect trainingBehavioural

    Also called Affective Modulation of Positivity (AMP)

    Behavioral training involving position emotion enhancement

Study groups in NCT04278365
Study groupRoleWhat they receive
AMP-AExperimentalParticipants 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).
Receives: Behavioral: Positive affect training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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

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

Secondary outcomes (8)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2020
  2. Study start16 Oct 2019
  3. Primary completion26 Mar 2020
  4. Study completion19 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04278365
Sponsor's protocol ID
2019-010
Acronym
AMP-A
Status last verified
Mar 2020
First submitted
18 Feb 2020
Last updated
1 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing Positive affect training in people with Anxiety and Depression, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence and Acceptability Scale (AAS) (time frame: Post-intervention (within approximately 2 weeks after completing intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04278365, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in