An interventional study of Amplification of Positivity Training and Cognitive-behavioral Therapy in Alcoholism, Alcohol Drinking and Drinking Behavior, sponsored by Charles Taylor. Suspended at 2 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-04-20.
Sponsored by Charles Taylor · Not applicable, Interventional, and Treatment
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.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 20 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →This is the only study on the registry with Charles Taylor as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Amplification of Positivity Training
Behavioral: Cognitive-behavioral Therapy
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.
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.
Time frame: 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.
Time frame: Post intervention (approximately 2 weeks after completing intervention)
Completion rate
Completion rate assessed as whether or not the participant completes all 12 sessions of intervention
Time frame: 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
The PROMIS Positive Affect and Well-being Scale 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.
Time frame: 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)
The ACQ assesses four dimensions of alcohol craving. A total score ranges from 1-12, with higher scores indicating higher levels of alcohol craving.
Time frame: 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
The Positive and Negative Affect Schedule (PANAS) measures positive affect. Items are answered on a 5 point scale, 1 (Very slightly or not at all) to 5 (Extremely). The positive affect scale ranges from 10-50 and higher scores indicate greater levels of positive affect.
Time frame: 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
The PROMIS Anxiety scale 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.
Time frame: 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
The PROMIS Depression scale 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.
Time frame: 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 level of functional disability as measured by the Sheehan Disability Scale (SDS)
The SDS assesses level of functional disability. Total score ranges from 0-30, with higher scores indicating greater impairment.
Time frame: 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 use
As measured by self-reported drinks per day
Time frame: 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 pleasure experience as measured by the Snaith-Hamilton Please Scale (SHAPS)
The SHAPS assesses the ability to experience pleasure. Total scores range from 0 to 14, with a higher score indicating higher levels of anhedonia.
Time frame: 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)
Plan to share: No
This study is suspended, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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