Affective Modulation of Positivity for Alcohol Use Disorder
Condition: Anxiety; Depression; Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional

Summary: 
      The proposed study is a pilot study examining the feasibility and potential utility of
      administering a psychosocial intervention termed Affective Modulation of Positivity (AMP) for
      individuals suffering from co-morbid depression or anxiety disorders and alcohol use disorder
      (AMP-A). The aims of this study are to (1) determine the feasibility and potential utility of
      administering AMP-A with individuals suffering from alcohol use disorders, (2) explore the
      potential impact of training on positive and negative affect, symptom severity, and
      functional disability, and (3) explore the potential impact of training on neural reactivity
      to reward and alcohol cues during functional magnetic resonance imaging (fMRI).
    

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.
    

Intervention name(s): Positive affect training
Intervention type(s): Behavioral
Intervention description(s): Behavioral training involving position emotion enhancement
Other intervention name(s): Affective Modulation of Positivity (AMP)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychological