xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06030154</url>
    </required_header>
    <id_info>
      <org_study_id>2022-003</org_study_id>
      <secondary_id>R34AA030688</secondary_id>
      <nct_id>NCT06030154</nct_id>
    </id_info>
    <brief_title>Amplification of Positivity for Alcohol Use</brief_title>
    <acronym>AMP-A</acronym>
    <official_title>Developing and Evaluating a Positive Valence Treatment for Alcohol Use Disorder With Anxiety or Depression</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Laureate Institute for Brain Research, Inc.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of California, San Diego</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Laureate Institute for Brain Research, Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The proposed study consists of two phases. During Phase 1, the investigators will recruit a&#xD;
        small sample of participants to complete a psychosocial intervention termed Amplification of&#xD;
        Positivity (AMP) for individuals experiencing comorbid depression or anxiety disorders and&#xD;
        alcohol use disorder (AMP-A). These participants will be asked to provide both qualitative&#xD;
        and quantitative input about the AMP-A intervention. Based on their input and clinician&#xD;
        input, the AMP-A manual will be modified for use in Phase 2. The goal is to recruit up to 20&#xD;
        participants in order to ensure there will be at least 8 participants who complete all&#xD;
        sessions of AMP-A. Phase 2 is a randomized clinical trial (RCT) protocol in which individuals&#xD;
        experiencing comorbid depression or anxiety disorders and alcohol use disorder will be&#xD;
        randomized to complete AMP-A or an evidence-based cognitive-behavioral therapy (CBT)&#xD;
        intervention. Up to 100 participants will be recruited in order to reach a target of N=60.&#xD;
        Assessed outcomes will include participant acceptability and completion rates, participant&#xD;
        compliance with the intervention, positive and negative affect, substance use- and depression&#xD;
        and anxiety-related symptom severity, functional disability, and neural reactivity to reward&#xD;
        and alcohol cues during functional magnetic resonance imaging (fMRI).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Substance use disorder, including alcohol use disorder, is characterized by enhanced neural&#xD;
        responsivity to drug (alcohol) cues, but reduced neural responsivity to non-drug reward cues.&#xD;
        These effects may be exacerbated by comorbid major depressive disorder (MDD) or symptoms of&#xD;
        anhedonia, comorbidities which are particularly high amongst alcohol use disorder. Response&#xD;
        rates for current interventions with alcohol use disorder are rather poor, with only 58%&#xD;
        experiencing benefits greater than control conditions. There is a need to identify&#xD;
        interventions that may target reward responsivity in a way that would promote recovery,&#xD;
        reduce affective disturbance, and support better long-term functioning for individuals&#xD;
        experiencing alcohol use disorder and comorbid depression and anxiety disorders. Positive&#xD;
        affect interventions have recently been developed and tested in other populations (i.e., HIV,&#xD;
        anxiety/depression) as a way of enhancing positive valence and reward processing. These&#xD;
        interventions have shown significant promise in these populations but have yet to be examined&#xD;
        in the context of alcohol use disorder.&#xD;
  &#xD;
        The current study would test the feasibility and acceptability of a 12-session protocol&#xD;
        focused on amplification of positivity with populations experiencing comorbid alcohol use&#xD;
        disorder and depression or anxiety disorders and explore the impact of the intervention on&#xD;
        positive affect, negative affect, alcohol use and craving, and neural response patterns&#xD;
        during reward and drug cue processing. The proposed project would support the final stages of&#xD;
        intervention development. First, an initial pilot study will be conducted to obtain&#xD;
        qualitative and quantitative input from N=8 participants with Alcohol Use Disorder (AUD) +&#xD;
        Anxiety/Depression (ANX/DEP) who are asked to engage in the amplification of positivity for&#xD;
        AUD intervention (AMP-A) and their clinicians to inform modifications to the AMP-A manual.&#xD;
        Then, a pilot randomized clinical trial (RCT) will be conducted in which N=60 individuals&#xD;
        with Alcohol Use Disorder (AUD) + Anxiety/Depression (ANX/DEP) will be randomized to complete&#xD;
        the modified AMP-A intervention or a cognitive behavioral therapy (CBT)intervention.&#xD;
        Intervention will consist of 12 sessions that may be done virtually or in-person.&#xD;
        Participation in both phases will include completion of interview-based and self-report&#xD;
        measures at pre-treatment, weekly during treatment, at post-treatment, and at 3-month&#xD;
        follow-up.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">July 2026</completion_date>
    <primary_completion_date type="Anticipated">July 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Perceived acceptability and satisfaction of the intervention as measured with the Adherence and Acceptability Scale (AAS)</measure>
      <time_frame>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)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in positive affect self-report measured with National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Positive Affect score</measure>
      <time_frame>Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in number of drinking days in the past month</measure>
      <time_frame>Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)</time_frame>
      <description>As measured through self-reported drinking days using Timeline Followback. This is a primary outcome for Phase 2.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Distress/Endorsement Validation Scale (DEVS)</measure>
      <time_frame>Average of total scores from the following time points:2 weeks after starting treatment, post-treatment (average of 16 weeks after baseline assessment)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Average drinks per drinking day</measure>
      <time_frame>Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)</time_frame>
      <description>As measured through self-reported drinks using a Timeline Followback interview. This is a secondary outcome for Phase 2.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale</measure>
      <time_frame>Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale</measure>
      <time_frame>Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Sheehan Disability Scale (SDS)</measure>
      <time_frame>Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the NIH Toolbox Loneliness survey</measure>
      <time_frame>Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose Scale</measure>
      <time_frame>Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Alcohol Use Disorder</condition>
    <condition>Anxiety</condition>
    <condition>Depression</condition>
    <arm_group>
      <arm_group_label>Amplification of Positivity Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cognitive Behavioral Therapy</intervention_name>
      <description>Cognitive Behavioral Therapy</description>
      <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Amplification of Positivity Therapy</intervention_name>
      <description>Amplification of Positivity Therapy</description>
      <arm_group_label>Amplification of Positivity Therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Surveys and Interviews</intervention_name>
      <description>Participants will answer questions regarding their mental and physical health as well as their substance use on the computer and in an interview format.</description>
      <arm_group_label>Amplification of Positivity Therapy</arm_group_label>
      <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age between 18 and 65 years old.&#xD;
  &#xD;
            2. Meeting diagnostic criteria for alcohol use disorder according to the DSM-5.&#xD;
  &#xD;
            3. Significant depression or anxiety symptoms as indexed by scoring Patient Health&#xD;
               Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale&#xD;
               (OASIS) ≥ 8.&#xD;
  &#xD;
            4. Below normative levels of positive affect as indexed by PROMIS Positive Affect &lt;50.&#xD;
  &#xD;
            5. Able to provide written informed consent.&#xD;
  &#xD;
            6. Have sufficient proficiency in the English language to understand and complete&#xD;
               interviews, questionnaires, and all other study procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Unwillingness or inability to complete any of the major aspects of the study protocol,&#xD;
               including self-report or behavioral assessment. However, failing to complete some&#xD;
               individual aspects of these assessment sessions will be acceptable (i.e., being&#xD;
               unwilling to answer individual items on some questionnaires or being unwilling to&#xD;
               complete a behavioral task). In addition, the neuroimaging portion of the protocol&#xD;
               will be optional.&#xD;
  &#xD;
            2. Non-correctable vision or hearing problems.&#xD;
  &#xD;
            3. No telephone or easy access to telephone.&#xD;
  &#xD;
            4. Diagnosis of Schizophrenia spectrum, other psychotic disorders, or bipolar I disorder.&#xD;
  &#xD;
            5. Active suicidal ideation with plan and intent to attempt suicide within the next&#xD;
               month.&#xD;
  &#xD;
            6. Has a history of unstable liver or renal insufficiency; glaucoma; significant and&#xD;
               unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,&#xD;
               hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in&#xD;
               the opinion of the investigator, would make participation not be in the best interest&#xD;
               (e.g., compromise the well-being) of the subject or that could prevent, limit, or&#xD;
               confound the protocol-specified assessments.&#xD;
  &#xD;
            7. A positive test for drugs of abuse, including alcohol (breath test), cocaine,&#xD;
               marijuana, opiates, amphetamines, methamphetamines, phencyclidine, benzodiazepines,&#xD;
               barbiturates, methadone, and oxycodone at the time of baseline assessments.&#xD;
               Participants will be asked to refrain from using alcohol within 24 hours prior to&#xD;
               assessment sessions and to refrain from using marijuana within 48 hours of assessment&#xD;
               sessions.&#xD;
  &#xD;
            8. Current use of a medication or change in the dose or prescription of a medication&#xD;
               within the 6 weeks prior to enrolling in the study that could potentially affect brain&#xD;
               functioning (e.g., stimulants, anxiolytics, antipsychotics, mood stabilizers,&#xD;
               anti-hypertensives). The current use of antidepressants (i.e., SSRIs) will not be&#xD;
               excluded as long as the dose has remained consistent for 6 weeks prior to baseline&#xD;
               assessment sessions. While individuals reporting use of benzodiazepines will be&#xD;
               excluded; individuals with sporadic use (i.e., less than once per week) may be&#xD;
               included, but will be asked to refrain from using within 72 hours prior to assessment&#xD;
               sessions. Inclusion of individuals reporting other types of medications or supplements&#xD;
               not listed or considered this far will be at the discretion of the PI according to&#xD;
               evidence in the literature of it affecting brain function or brain blood flow.&#xD;
  &#xD;
            9. Taking drugs that affect the fMRI hemodynamic response (e.g., methylphenidate,&#xD;
               acetazolamide, and excessive caffeine intake &gt; 1000 mg/day) - Phase 2 only&#xD;
  &#xD;
           10. Concurrent engagement in psychosocial treatments that specifically target alcohol use&#xD;
               disorder or mood/anxiety symptoms and began within 12 weeks of baseline assessments.&#xD;
               Individuals concurrently receiving psychosocial treatments for other symptoms, or that&#xD;
               are not specifically targeting symptoms (e.g., ongoing support groups) will not be&#xD;
               excluded as long as the dose of treatment (i.e., frequency of sessions) has not&#xD;
               changed significantly within 6 weeks prior to enrolling in the study.&#xD;
  &#xD;
           11. MRI contraindications (for those in Phase 2 opting into this portion) including:&#xD;
               cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm&#xD;
               clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve&#xD;
               replacement, shunt (ventricular or spinal), electrodes, metal&#xD;
               plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit), persons who have ever&#xD;
               been a professional metal worker/welder, history of eye surgery/eyes washed out&#xD;
               because of metal, vision problems uncorrectable with lenses, inability to lie still on&#xD;
               one's back for 60-120 minutes; prior neurosurgery; tattoos or cosmetic makeup with&#xD;
               metal dyes, unwillingness to remove body piercings, and pregnancy - Phase 2 only&#xD;
  &#xD;
           12. Moderate to severe traumatic brain injury (&gt;30 min. loss of consciousness or &gt;24 hours&#xD;
               posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological&#xD;
               deficits, neurological disorders, or severe or unstable medical conditions that might&#xD;
               be compromised by participation in the study (to be determined by primary care&#xD;
               provider).&#xD;
  &#xD;
           13. Severity of alcohol use disorder requiring more intensive treatment (i.e., intensive&#xD;
               outpatient or residential), as determined by baseline assessments conducted by&#xD;
               licensed clinicians.&#xD;
  &#xD;
           14. Given the current study involves development of the positive affect intervention,&#xD;
               special vulnerable populations (pregnant women, fetuses, neonates, prisoners,&#xD;
               children) will not be enrolled.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Robin L Aupperle, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Laureate Institute for Brain Research</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Robin L Aupperle, PhD</last_name>
      <phone>918-502-5155</phone>
      <email>neurocatt@laureateinstitute.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Laureate Institute for Brain Research</name>
        <address>
          <city>Tulsa</city>
          <state>Oklahoma</state>
          <zip>74008</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Robin L Aupperle, PhD</last_name>
        <phone>918-502-5155</phone>
        <email>neurocatt@laureateinstitute.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>34253077</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>28060463</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>33894554</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alcoholism</mesh_term>
      <mesh_term>Depression</mesh_term>
      <mesh_term>Alcohol Drinking</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>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.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>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.</ipd_time_frame>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>April 4, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT06030154/Prot_SAP_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 29, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT06030154/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06030154
  org study id: 2022-003
  secondary id: R34AA030688
  nct id: NCT06030154
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Perceived acceptability and satisfaction of the intervention as measured with the Adherence and Acceptability Scale (AAS)
  time frame: 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)
  description: 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.
  measure: Change in positive affect self-report measured with National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Positive Affect score
  time frame: Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)
  description: 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.
  measure: Change in number of drinking days in the past month
  time frame: Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)
  description: As measured through self-reported drinking days using Timeline Followback. This is a primary outcome for Phase 2.
  measure: Distress/Endorsement Validation Scale (DEVS)
  time frame: Average of total scores from the following time points:2 weeks after starting treatment, post-treatment (average of 16 weeks after baseline assessment)
  description: 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.
  measure: Change in Average drinks per drinking day
  time frame: Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)
  description: As measured through self-reported drinks using a Timeline Followback interview. This is a secondary outcome for Phase 2.
  measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
  time frame: Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)
  description: 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.
  measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale
  time frame: Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)
  description: 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.
  measure: Change in Sheehan Disability Scale (SDS)
  time frame: Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)
  description: 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.
  measure: Change in the NIH Toolbox Loneliness survey
  time frame: Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)
  description: 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.
  measure: Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose Scale
  time frame: Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment)
  description: 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.
  arm group label: Amplification of Positivity Therapy
  arm group type: Experimental
  description: 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.
  arm group label: Cognitive Behavioral Therapy
  arm group type: Active Comparator
  description: 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.
  intervention type: Behavioral
  intervention name: Cognitive Behavioral Therapy
  description: Cognitive Behavioral Therapy
  arm group label: Cognitive Behavioral Therapy
  intervention type: Behavioral
  intervention name: Amplification of Positivity Therapy
  description: Amplification of Positivity Therapy
  arm group label: Amplification of Positivity Therapy
  intervention type: Behavioral
  intervention name: Surveys and Interviews
  description: Participants will answer questions regarding their mental and physical health as well as their substance use on the computer and in an interview format.
  arm group label: Amplification of Positivity Therapy
  arm group label: Cognitive Behavioral Therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Robin L Aupperle, PhD
  role: Principal Investigator
  affiliation: Laureate Institute for Brain Research
  last name: Robin L Aupperle, PhD
  phone: 918-502-5155
  email: neurocatt@laureateinstitute.org
  facility: 
  status: Recruiting
  contact: 
  country: United States
  citation: 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
  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.
  PMID: 28060463
  citation: 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.
  PMID: 33894554
  responsible party type: Sponsor
  mesh term: Alcoholism
  mesh term: Depression
  mesh term: Alcohol Drinking
  sharing ipd: Yes
  ipd description: 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.
  ipd info type: Study Protocol
  ipd time frame: 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.
  provided document: 
  provided document: 