Affective Modulation of Positivity for Alcohol Use Disorder
- Conditions
- AnxietyDepressionAlcohol Use Disorder
- Interventions
- Behavioral: Positive affect training
- Registration Number
- NCT04278365
- Lead Sponsor
- Laureate Institute for Brain Research, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AMP-A Positive affect training Participants 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).
- Primary Outcome Measures
Name Time Method Completion rate Post-intervention (within approximately 2 weeks after completing intervention) Completion rate assessed as whether or not the participant completes all 11 sessions of intervention
Distress/Endorsement Validation Scale (DEVS) Post-intervention (within approximately 2 weeks after completing intervention) 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.
Adherence and Acceptability Scale (AAS) Post-intervention (within approximately 2 weeks after completing intervention) 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.
- Secondary Outcome Measures
Name Time Method Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale 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) 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.
Change in Sheehan Disability Scale 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) This measures assesses level of functional disability. Total score ranges from 0-30, with higher scores indicating greater impairment.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect and Well-being Scale 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) 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.
Change in alcohol use 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) As measured by self-reported drinks per day
Change in Alcohol Craving Questionnaire 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) This measure assesses four dimensions of alcohol craving. A total score ranges from 1-12, with higher scores indicating higher levels of alcohol craving.
Change in Positive and Negative Affect Schedule (PANAS) 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) 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.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale 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) 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.
Change in Snaith-Hamilton Please Scale (SHAPS) 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) This measure assesses the ability to experience pleasure. Total scores range from 0 to 14, with a higher score indicating higher levels of anhedonia.
Trial Locations
- Locations (1)
Laureate Institute for Brain Research
🇺🇸Tulsa, Oklahoma, United States