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| ID | Type | Description | Link |
|---|---|---|---|
| R34AA030688 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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).
Substance use disorder, including alcohol use disorder, is characterized by enhanced neural responsivity to drug (alcohol) cues, but reduced neural responsivity to non-drug reward cues. These effects may be exacerbated by comorbid major depressive disorder (MDD) or symptoms of anhedonia, comorbidities which are particularly high amongst alcohol use disorder. Response rates for current interventions with alcohol use disorder are rather poor, with only 58% experiencing benefits greater than control conditions. There is a need to identify interventions that may target reward responsivity in a way that would promote recovery, reduce affective disturbance, and support better long-term functioning for individuals experiencing alcohol use disorder and comorbid depression and anxiety disorders. Positive affect interventions have recently been developed and tested in other populations (i.e., HIV, anxiety/depression) as a way of enhancing positive valence and reward processing. These interventions have shown significant promise in these populations but have yet to be examined in the context of alcohol use disorder.
The current study would test the feasibility and acceptability of a 12-session protocol focused on amplification of positivity with populations experiencing comorbid alcohol use disorder and depression or anxiety disorders and explore the impact of the intervention on positive affect, negative affect, alcohol use and craving, and neural response patterns during reward and drug cue processing. The proposed project would support the final stages of intervention development. First, an initial pilot study will be conducted to obtain qualitative and quantitative input from N=8 participants with Alcohol Use Disorder (AUD) + Anxiety/Depression (ANX/DEP) who are asked to engage in the amplification of positivity for AUD intervention (AMP-A) and their clinicians to inform modifications to the AMP-A manual. Then, a pilot randomized clinical trial (RCT) will be conducted in which N=60 individuals with Alcohol Use Disorder (AUD) + Anxiety/Depression (ANX/DEP) will be randomized to complete the modified AMP-A intervention or a cognitive behavioral therapy (CBT)intervention. Intervention will consist of 12 sessions that may be done virtually or in-person. Participation in both phases will include completion of interview-based and self-report measures at pre-treatment, weekly during treatment, at post-treatment, and at 3-month follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | Cognitive Behavioral Therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Distress/Endorsement Validation Scale (DEVS) | This measure assesses two factors, distress (7 items) and endorsement (3 items) and is a secondary outcome for Phase 1. 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robin L Aupperle, PhD | Contact | 918-502-5155 | neurocatt@laureateinstitute.org |
| Name | Affiliation | Role |
|---|---|---|
| Robin L Aupperle, PhD | Laureate Institute for Brain Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laureate Institute for Brain Research | Recruiting | Tulsa | Oklahoma | 74008 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34253077 | 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. | |
| 28060463 | 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. |
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The investigators plan on sharing human data from the completed project with qualified investigators via the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) in compliance with NOT-AA-22-011 as applicable.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2023 | Aug 29, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 29, 2022 | Jul 11, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D011795 | Surveys and Questionnaires |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D003625 | Data Collection |
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| Amplification of Positivity Therapy |
| Behavioral |
Amplification of Positivity Therapy |
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| 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. |
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| 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 | As measured through self-reported drinks using a Timeline Followback interview. This is a secondary 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 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 a range of 0-100. Higher scores indicating greater symptoms of anxiety. This is a secondary 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 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 a range of 0-100. Higher scores indicating greater symptoms of depression. This is a secondary 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 Sheehan Disability Scale (SDS) | This measure assesses functional impairment, with higher scores indicating greater disability. Scores range from 0 to 30. This is a secondary 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 the NIH Toolbox Loneliness survey | This measure assesses feelings related to loneliness over the past month. The total score ranges from 5-25, with higher scores indicating greater feelings of loneliness. This is a secondary 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 the Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose Scale | This measure assesses general feelings related to meaning and purpose in one's life. The score is presented as a T score with a mean of 50 and standard deviation of 10 with a range of 0-100. Higher scores indicating greater feelings of meaning and purpose. This is a secondary outcome for Phase 2. | Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment) |
| 33894554 | 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. |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D004812 |
| Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |