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Amplification of Positivity for Alcohol Use Disorder Co-Occurring With Anxiety or Depression

Primary Purpose

Alcoholism, Alcohol Drinking, Drinking Behavior

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amplification of Positivity Training
Cognitive-behavioral Therapy
Sponsored by
Charles Taylor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).
  • Non-correctable vision or hearing problems.
  • No telephone or easy access to telephone.
  • Diagnosis of Schizophrenia spectrum, other psychotic disorders, or bipolar I disorder.
  • 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 alcohol (breath test) 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.
  • Initiation of a new psychotropic medication (e.g., SSRIs) or change in the dose or prescription of a medication within the 6 weeks prior to enrolling in the study.
  • 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.
  • 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 baseline assessments conducted by clinicians.

Sites / Locations

  • Altman Clinical and Translational Research Institute
  • Laureate Institute for Brain Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Amplification of Positivity for Alcohol Use Disorders (AMP-A; 12 sessions)

Cognitive-behavioral Therapy (CBT; 12 sessions)

Arm Description

Outcomes

Primary Outcome Measures

Adherence and Acceptability Scale (AAS)
The AAS 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.
Distress/Endorsement Validation Scale (DEVS)
The DEVS 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.
Completion rate
Completion rate assessed as whether or not the participant completes all 12 sessions of intervention

Secondary Outcome Measures

Change from baseline in well-being as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect and Well-being Scale
The PROMIS Positive Affect and Well-being Scale 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.
Change from baseline in alcohol craving as measured by the Alcohol Craving Questionnaire (ACQ)
The ACQ assesses four dimensions of alcohol craving. A total score ranges from 1-12, with higher scores indicating higher levels of alcohol craving.
Change from baseline in positive affect as measured by Positive and Negative Affect Schedule
The Positive and Negative Affect Schedule (PANAS) measures positive affect. Items are answered on a 5 point scale, 1 (Very slightly or not at all) to 5 (Extremely). The positive affect scale ranges from 10-50 and higher scores indicate greater levels of positive affect.
Change from baseline in anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
The PROMIS Anxiety scale 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.
Change from baseline in depression as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale
The PROMIS Depression scale 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.
Change from baseline in level of functional disability as measured by the Sheehan Disability Scale (SDS)
The SDS assesses level of functional disability. Total score ranges from 0-30, with higher scores indicating greater impairment.
Change from baseline in alcohol use
As measured by self-reported drinks per day
Change from baseline in pleasure experience as measured by the Snaith-Hamilton Please Scale (SHAPS)
The SHAPS assesses the ability to experience pleasure. Total scores range from 0 to 14, with a higher score indicating higher levels of anhedonia.

Full Information

First Posted
June 14, 2021
Last Updated
April 12, 2022
Sponsor
Charles Taylor
Collaborators
Laureate Institute for Brain Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04934553
Brief Title
Amplification of Positivity for Alcohol Use Disorder Co-Occurring With Anxiety or Depression
Official Title
Amplification of Positivity for Alcohol Use Disorder (AMP-A): Feasibility and Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Suspended
Why Stopped
Limited funding
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Charles Taylor
Collaborators
Laureate Institute for Brain Research, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to examine the feasibility of a protocol in which individuals with comorbid depression or anxiety disorders and alcohol use disorder will be randomized to complete Amplification of Positivity for Alcohol Use Disorder (AMP-A)- a psychological treatment focused on increasing positive thoughts, emotions, and behaviors- or a traditional cognitive-behavioral therapy (CBT) intervention. 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, and functional disability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Alcohol Drinking, Drinking Behavior, Alcohol-Related Disorders, Substance-Related Disorders, Mental Disorder, Anxiety, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amplification of Positivity for Alcohol Use Disorders (AMP-A; 12 sessions)
Arm Type
Experimental
Arm Title
Cognitive-behavioral Therapy (CBT; 12 sessions)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Amplification of Positivity Training
Intervention Description
12 90-minute, clinician-administered treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) designed to increase positive emotions, cognitions, and behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral Therapy
Intervention Description
12 90-minute, clinician-administered treatment sessions focused on strategies to alter cognitions and behavior related to alcohol use.
Primary Outcome Measure Information:
Title
Adherence and Acceptability Scale (AAS)
Description
The AAS 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 (approximately 2 weeks after completing intervention)
Title
Distress/Endorsement Validation Scale (DEVS)
Description
The DEVS 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 (approximately 2 weeks after completing intervention)
Title
Completion rate
Description
Completion rate assessed as whether or not the participant completes all 12 sessions of intervention
Time Frame
Post intervention (approximately 2 weeks after completing intervention)
Secondary Outcome Measure Information:
Title
Change from baseline in well-being as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect and Well-being Scale
Description
The PROMIS Positive Affect and Well-being Scale 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
Baseline, 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)
Title
Change from baseline in alcohol craving as measured by the Alcohol Craving Questionnaire (ACQ)
Description
The ACQ assesses four dimensions of alcohol craving. A total score ranges from 1-12, with higher scores indicating higher levels of alcohol craving.
Time Frame
Baseline, 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)
Title
Change from baseline in positive affect as measured by Positive and Negative Affect Schedule
Description
The Positive and Negative Affect Schedule (PANAS) measures positive affect. Items are answered on a 5 point scale, 1 (Very slightly or not at all) to 5 (Extremely). The positive affect scale ranges from 10-50 and higher scores indicate greater levels of positive affect.
Time Frame
Baseline, 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)
Title
Change from baseline in anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
Description
The PROMIS Anxiety scale 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
Baseline, 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)
Title
Change from baseline in depression as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale
Description
The PROMIS Depression scale 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
Baseline, 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)
Title
Change from baseline in level of functional disability as measured by the Sheehan Disability Scale (SDS)
Description
The SDS assesses level of functional disability. Total score ranges from 0-30, with higher scores indicating greater impairment.
Time Frame
Baseline, 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)
Title
Change from baseline in alcohol use
Description
As measured by self-reported drinks per day
Time Frame
Baseline, 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)
Title
Change from baseline in pleasure experience as measured by the Snaith-Hamilton Please Scale (SHAPS)
Description
The SHAPS assesses the ability to experience pleasure. Total scores range from 0 to 14, with a higher score indicating higher levels of anhedonia.
Time Frame
Baseline, 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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 55 years old. Meet diagnostic criteria for alcohol use disorder according to the DSM-5 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. Able to provide written informed consent. Have sufficient proficiency in the English language to understand and complete interviews, questionnaires, and all other study procedures. Completion of at least an 8th grade education, to help facilitate ability to engage in the written materials included in the treatments. Exclusion Criteria: 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). Non-correctable vision or hearing problems. No telephone or easy access to telephone. Diagnosis of Schizophrenia spectrum, other psychotic disorders, or bipolar I disorder. 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 alcohol (breath test) 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. Initiation of a new psychotropic medication (e.g., SSRIs) or change in the dose or prescription of a medication within the 6 weeks prior to enrolling in the study. 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. 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 baseline assessments conducted by clinicians.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles T Taylor, PhD
Organizational Affiliation
Altman Clinical and Translational Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robin Aupperle, PhD
Organizational Affiliation
Laureate Institute for Brain Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altman Clinical and Translational Research Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Laureate Institute for Brain Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28060463
Citation
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.
Results Reference
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Amplification of Positivity for Alcohol Use Disorder Co-Occurring With Anxiety or Depression

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