AlcoholismNCT04934553
Amplification of Positivity for Alcohol Use Disorder Co-Occurring With Anxiety or Depression
A study testing Amplification of Positivity Training and Cognitive-behavioral Therapy in people with Alcoholism and Alcohol Drinking, run by Charles Taylor at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Alcoholism, Alcohol Drinking, Drinking Behavior
- What is being tested?
- Amplification of Positivity Training and Cognitive-behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 May 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 55 years old.
- Meet diagnostic criteria for alcohol use disorder according to the DSM-5
- Significant depression or anxiety symptoms as indexed by scoring Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8.
- Able to provide written informed consent.
- Have sufficient proficiency in the English language to understand and complete interviews, questionnaires, and all other study procedures.
- Completion of at least an 8th grade education, to help facilitate ability to engage in the written materials included in the treatments.
Who cannot join
- Unwillingness or inability to complete any of the major aspects of the study protocol, including self-report or behavioral assessment. However, failing to complete some individual aspects of these assessment sessions will be acceptable (i.e., being unwilling to answer individual items on some questionnaires or being unwilling to complete a behavioral task).
- Non-correctable vision or hearing problems.
- No telephone or easy access to telephone.
- Diagnosis of Schizophrenia spectrum, other psychotic disorders, or bipolar I disorder.
- Active suicidal ideation with plan and intent to attempt suicide within the next month.
- Has a history of unstable liver or renal insufficiency; glaucoma; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
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- A positive test for alcohol (breath test) at the time of baseline assessments. Participants will be asked to refrain from using alcohol within 24 hours prior to assessment sessions and to refrain from using marijuana within 48 hours of assessment sessions.
- Initiation of a new psychotropic medication (e.g., SSRIs) or change in the dose or prescription of a medication within the 6 weeks prior to enrolling in the study.
- Concurrent engagement in psychosocial treatments that specifically target alcohol use disorder or mood/anxiety symptoms and began within 12 weeks of baseline assessments. Individuals concurrently receiving psychosocial treatments for other symptoms, or that are not specifically targeting symptoms (e.g., ongoing support groups) will not be excluded as long as the dose of treatment (i.e., frequency of sessions) has not changed significantly within 6 weeks prior to enrolling in the study.
- Moderate to severe traumatic brain injury (>30 min. loss of consciousness or >24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits, neurological disorders, or severe or unstable medical conditions that might be compromised by participation in the study (to be determined by primary care provider).
- Severity of alcohol use disorder requiring more intensive treatment (i.e., intensive outpatient or residential), as determined by baseline assessments conducted by clinicians.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Altman Clinical and Translational Research Institute
La Jolla, California, 92037
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
Official title: Amplification of Positivity for Alcohol Use Disorder (AMP-A): Feasibility and Pilot Study
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.
- Conditions
- Alcoholism, Alcohol Drinking, Drinking Behavior, Alcohol-Related Disorders, Substance-Related Disorders, Mental Disorder
- Being tested
- Amplification of Positivity Training, Cognitive-behavioral Therapy
- Medical subject headings
- Alcoholism, Alcohol Drinking, Drinking Behavior, Alcohol-Related Disorders, Substance-Related Disorders, Mental Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amplification of Positivity TrainingBehavioural
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.
Cognitive-behavioral TherapyBehavioural
12 90-minute, clinician-administered treatment sessions focused on strategies to alter cognitions and behavior related to alcohol use.
| Study group | Role | What they receive |
|---|---|---|
| Amplification of Positivity for Alcohol Use Disorders (AMP-A; 12 sessions) | Experimental | Not described Receives: Behavioral: Amplification of Positivity Training |
| Cognitive-behavioral Therapy (CBT; 12 sessions) | Active comparator | Not described Receives: Behavioral: Cognitive-behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Post intervention (approximately 2 weeks after completing intervention)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start20 May 2021
- Primary completionJan 2023 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: Limited funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles Taylor
- Sponsor type
- University, hospital or other
- Collaborators
- Laureate Institute for Brain Research, Inc.
- Responsible party
- Sponsor-investigator, Charles Taylor, University of California, San Diego
- Investigators
- Charles T Taylor, PhD, Principal investigator, Altman Clinical and Translational Research InstituteRobin Aupperle, PhD, Principal investigator, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934553
- Sponsor's protocol ID
- 210136
- Status last verified
- Apr 2022
- First submitted
- 14 Jun 2021
- Last updated
- 20 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28060463
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplification of Positivity for Alcohol Use Disorder (AMP-A): Feasibility and Pilot Study
- ClinicalTrials.gov ID
- NCT04934553
- Acronym / sponsor ID
- 210136
- Conditions
- Alcoholism, Alcohol Drinking, Drinking Behavior, Alcohol-Related Disorders, Substance-Related Disorders, Mental Disorder
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Limited funding
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Charles TaylorUniversity, hospital or other
- Collaborators
- Laureate Institute for Brain Research, Inc.
- Study start
- 20 May 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amplification of Positivity for Alcohol Use Disorders (AMP-A; 12 sessions) | Experimental | Behavioral: Amplification of Positivity Training |
| Cognitive-behavioral Therapy (CBT; 12 sessions) | Active comparator | Behavioral: Cognitive-behavioral Therapy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 55 years old.
- Meet diagnostic criteria for alcohol use disorder according to the DSM-5
- Significant depression or anxiety symptoms as indexed by scoring Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8.
- Able to provide written informed consent.
- Have sufficient proficiency in the English language to understand and complete interviews, questionnaires, and all other study procedures.
Key exclusion criteria (11 listed)
- Unwillingness or inability to complete any of the major aspects of the study protocol, including self-report or behavioral assessment. However, failing to complete some individual aspects of these assessment sessions will be acceptable (i.e., being unwilling to answer individual items on some questionnaires or being unwilling to complete a behavioral task).
- Non-correctable vision or hearing problems.
- No telephone or easy access to telephone.
- Diagnosis of Schizophrenia spectrum, other psychotic disorders, or bipolar I disorder.
- Active suicidal ideation with plan and intent to attempt suicide within the next month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amplification of Positivity Training12 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. | Behavioural | Amplification of Positivity for Alcohol Use Disorders (AMP-A; 12 sessions) |
| Cognitive-behavioral Therapy12 90-minute, clinician-administered treatment sessions focused on strategies to alter cognitions and behavior related to alcohol use. | Behavioural | Cognitive-behavioral Therapy (CBT; 12 sessions) |
Primary outcome
Adherence and Acceptability Scale (AAS)
Time frame: Post intervention (approximately 2 weeks after completing intervention)
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.
Distress/Endorsement Validation Scale (DEVS)
Time frame: Post intervention (approximately 2 weeks after completing intervention)
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.
Completion rate
Time frame: Post intervention (approximately 2 weeks after completing intervention)
Completion rate assessed as whether or not the participant completes all 12 sessions of intervention
8 secondary outcomes
Change from baseline in well-being as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect and Well-being Scale
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)
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
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
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
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)
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
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Background: PubMed 28060463Taylor 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles T Taylor, PhD principal investigator
Altman Clinical and Translational Research Institute
Robin Aupperle, PhD principal investigator
Laureate Institute for Brain Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amplification of Positivity Training and Cognitive-behavioral Therapy in people with Alcoholism and Alcohol Drinking, run by Charles Taylor at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence and Acceptability Scale (AAS) (time frame: Post intervention (approximately 2 weeks after completing intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04934553, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.