Study Stopped
Limited funding
Limited funding
Sponsor study identifier
interventional
20
1 country
2
Study Start
May 20, 2021
Actual (reported)Primary Completion
January 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 20, 2021
Actual (reported)June 14, 2021
Actual (reported)June 22, 2021
Actual (reported)January 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Post intervention (approximately 2 weeks after completing intervention)
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.
Post intervention (approximately 2 weeks after completing intervention)
Completion rate
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.
12 90-minute, clinician-administered treatment sessions focused on strategies to alter cognitions and behavior related to alcohol use.
Altman Clinical and Translational Research Institute
La Jolla, California, 92037, United States
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136, United States
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.
Charles T Taylor, PhD
Altman Clinical and Translational Research Institute
Robin Aupperle, PhD
Laureate Institute for Brain Research
First Submitted
June 14, 2021
First Posted
June 22, 2021
Study Start
May 20, 2021
Actual (reported)Primary Completion
January 2023
Estimated (date passed)Cognitive-Behavioral and Physical Activity Interventions for Binge Eating and Overweight
Completion rate assessed as whether or not the participant completes all 12 sessions of intervention
Post intervention (approximately 2 weeks after completing intervention)
Change from baseline in well-being as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect and Well-being Scale
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)
Change from baseline in alcohol craving as measured by the Alcohol Craving Questionnaire (ACQ)
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)
Change from baseline in positive affect as measured by Positive and Negative Affect Schedule
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)
Change from baseline in anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
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)
Change from baseline in depression as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale
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)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 20, 2022
Record last verified: 2022-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: