Amplification of Positivity + Cognitive Behavioral Therapy for Alcoholism

(AMP-A Trial)

Overseen By Robin L Aupperle, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laureate Institute for Brain Research, Inc.

Must not be taking: Stimulants, Anxiolytics, Antipsychotics, others

Disqualifiers: Schizophrenia, Bipolar, Suicidal ideation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 27

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two therapy approaches for individuals dealing with both depression or anxiety and alcohol use issues. One group will undergo Amplification of Positivity Therapy, which boosts positive thoughts and feelings. The other group will receive Cognitive Behavioral Therapy (CBT), a well-known method that helps individuals understand the link between their thoughts and alcohol use. The trial aims to determine which approach better improves mood and reduces alcohol use. It seeks participants who struggle with alcohol use and experience significant depression or anxiety symptoms.

As an unphased trial, this study offers a unique opportunity to contribute to understanding effective therapies for mental health and alcohol use challenges.

Will I have to stop taking my current medications?

The trial requires that you have not changed the dose or prescription of any medication that could affect brain functioning in the 6 weeks before enrolling. You can continue taking antidepressants like SSRIs if the dose has been stable for 6 weeks. If you use benzodiazepines less than once a week, you may be included but must refrain from using them 72 hours before assessments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Behavioral Therapy (CBT) is generally safe for treating alcohol use problems. It has been extensively tested, and many people tolerate it well. Studies indicate that CBT, whether conducted online or in person, helps people reduce their drinking without major side effects.

For Amplification of Positivity Therapy, less detailed information is available. Past patients have demonstrated that this therapy is feasible and might be beneficial. However, as it remains in early testing, there is not yet as much solid data on its safety.

Both treatments in this trial involve talking with a therapist, not taking medication, which usually results in fewer physical side effects. Consulting a professional about any concerns before starting is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Amplification of Positivity Therapy because it takes a unique approach to treating alcoholism by focusing on boosting positive thoughts, emotions, and behaviors. Unlike traditional therapies that often concentrate on reducing negative behaviors, this method aims to enhance well-being and potentially alleviate anxiety and depression, which can contribute to alcohol misuse. Meanwhile, Cognitive Behavioral Therapy (CBT) remains a strong option, as it helps individuals understand and change the relationship between their thoughts, emotions, and alcohol use, providing a more structured way to address these issues. Together, these therapies offer fresh perspectives and hope for individuals seeking to overcome alcohol addiction.

What evidence suggests that this trial's treatments could be effective for alcohol use disorder?

This trial will compare Amplification of Positivity Therapy (AMP) with Cognitive Behavioral Therapy (CBT) for treating alcohol use disorder. Research shows that AMP might assist individuals with alcohol use disorder, depression, and anxiety. Early studies with small groups suggest it could increase positive feelings and thoughts, potentially leading to reduced alcohol use. However, more detailed information is needed to determine its effectiveness.

In contrast, CBT is a well-known treatment for alcohol use disorder. Studies demonstrate that CBT effectively helps individuals reduce drinking by teaching them to understand and change the thoughts and feelings related to their drinking. It is a widely recommended treatment with strong evidence supporting its effectiveness. ^{1 2 3 4 6}

Who Is on the Research Team?

Robin L Aupperle, PhD

Principal Investigator

Laureate Institute for Brain Research

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-65 with alcohol use disorder and depression or anxiety, scoring above certain thresholds on the PHQ-9 or OASIS. Excluded are those using drugs affecting brain function, engaged in other psychosocial treatments for substance use or mood/anxiety within recent weeks, with severe medical conditions, MRI contraindications (Phase 2), or requiring intensive alcohol disorder treatment.

Inclusion Criteria

Below normative levels of positive affect as indexed by PROMIS Positive Affect <50

Able to provide written informed consent

Have sufficient proficiency in the English language to understand and complete interviews, questionnaires, and all other study procedures

Exclusion Criteria

I am willing and able to participate in most parts of the study but may not complete every single task.

I have vision or hearing issues that cannot be corrected.

I have been diagnosed with schizophrenia, a related psychotic disorder, or bipolar I.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Pilot Study

Initial pilot study to obtain qualitative and quantitative input from participants and clinicians to inform modifications to the AMP-A manual.

12 weeks

12 visits (in-person or virtual)

Phase 2: Randomized Clinical Trial

Participants are randomized to complete either the modified AMP-A intervention or a cognitive behavioral therapy (CBT) intervention.

12 weeks

12 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of outcomes such as positive affect, depression, and anxiety.

16 weeks

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Amplification of Positivity Therapy
• Cognitive Behavioral Therapy

Trial Overview The study tests Amplification of Positivity Therapy (AMP-A) against Cognitive Behavioral Therapy (CBT) for people with both alcohol use disorder and depression/anxiety. Phase 1 refines AMP-A based on participant/clinician feedback. Phase 2 randomly assigns participants to either AMP-A or CBT to compare effectiveness via surveys/interviews and fMRI scans.

How Is the Trial Designed?

Group I: Amplification of Positivity Therapy Experimental Treatment 2 Interventions

AMP-A will involve 12, one-hour weekly therapy sessions completed one-on-one with a therapist. The sessions and between-session homework will focus on amplifying positive thoughts, emotions, and behaviors to address anxiety/depression and alcohol use.

Group II: Cognitive Behavioral Therapy Active Control 2 Interventions

The CBT intervention will involve 12, one-hour weekly therapy sessions completed one-on-one with a therapist. The sessions and between-session homework will focus on monitoring of the relationship between thoughts, emotions, and alcohol use.

Who Is Running the Clinical Trial?

Laureate Institute for Brain Research, Inc.

Lead Sponsor

Trials

53

Recruited

5,400+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

The study explored a behavioral intervention called Amplification of Positivity (AMP) in eight adults with alcohol use disorder and significant depression or anxiety, showing it to be feasible and acceptable with moderate to high ratings for treatment credibility and participant endorsement.

Preliminary analyses indicated medium to large effect sizes for improvements in alcohol use, depression, anxiety, and positive affect after the intervention, suggesting that AMP could be a promising approach for future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amplification of Positivity Therapy for Co-occurring Alcohol Use Disorder with Depression and Anxiety Symptoms: Pilot Feasibility Study and Case Series. Akeman, E., White, E., Wolitzky-Taylor, K., et al.[2022]

A meta-analysis of 51 positive psychology interventions involving 4,266 individuals showed that these interventions significantly improve well-being and reduce depressive symptoms, with effect sizes of r=0.29 and r=0.31, respectively.

Factors such as the participants' depression status, age, and the format and duration of the interventions influence their effectiveness, suggesting that clinicians should tailor positive psychology techniques to individual needs, especially for older or highly motivated clients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing well-being and alleviating depressive symptoms with positive psychology interventions: a practice-friendly meta-analysis. Sin, NL., Lyubomirsky, S.[2022]

In a study of 140 adults with cocaine use disorder undergoing web-based cognitive-behavior therapy (CBT), higher baseline positive affect (PA) was linked to less frequent cocaine use during treatment, suggesting that enhancing positive emotions may improve treatment outcomes.

While negative affect (NA) scores decreased over time in both CBT and treatment as usual, higher NA during treatment was associated with increased cocaine use, indicating that managing negative emotions could be crucial for successful recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive and negative affect in cocaine use disorder treatment: Change across time and relevance to treatment outcome. Decker, SE., Morie, KP., Malin-Mayo, B., et al.[2020]

The Skills to Enhance Positivity (STEP) intervention aims to increase positive affect in adolescents at risk of suicide and has shown promise in a pilot study by reducing suicidal events and ideation.

The ongoing randomized controlled trial will compare STEP to Enhanced Treatment as Usual (ETAU) to determine its effectiveness in decreasing suicidal behaviors and improving positive emotional experiences over a 6-month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skills to Enhance Positivity in adolescents at risk for suicide: Protocol for a randomized controlled trial. Yen, S., Suazo, N., Doerr, J., et al.[2023]

A single-session positive psychotherapy intervention was successfully implemented in acute psychiatric wards, with 89% of the session components delivered as planned and 80% of participants identifying a personal character strength.

Participants reported a significant increase in positive mood after the session, with an average helpfulness rating of 8.5 out of 10, indicating that the intervention is both feasible and beneficial for individuals with severe mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Character Strength-Focused Positive Psychotherapy on Acute Psychiatric Wards: A Feasibility and Acceptability Study. Kouvaras, S., Guiotto, M., Schrank, B., et al.[2022]

Clients receiving positive cognitive behavioral therapy (CBT) reported a preference for this approach over traditional CBT, experiencing a steeper learning curve and greater empowerment during treatment.

The study found that focusing on positive moments and strengths effectively countered depressive symptoms and enhanced overall well-being, highlighting the motivational benefits of positive CBT's upbeat tone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positivity pays off: Clients' perspectives on positive compared with traditional cognitive behavioral therapy for depression. Geschwind, N., Bosgraaf, E., Bannink, F., et al.[2021]

Patients found motivational enhancement therapy (MET) effective for alcohol use disorder, appreciating the supportive relationship with their therapist, which was crucial for fostering a positive therapeutic environment.

However, participants expressed a desire for more guidance in goal-setting and longer treatment duration to better support their self-efficacy for change, indicating that while MET is beneficial, adjustments could enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative interview study of patient experiences of receiving motivational enhancement therapy in a Swedish addiction specialist treatment setting. Ingesson Hammarberg, S., Sundbye, J., Tingvall, R., et al.[2023]

Acamprosate is more effective than naltrexone for maintaining abstinence in individuals with alcohol use disorders, while naltrexone is better at reducing heavy drinking and cravings.

The effectiveness of naltrexone improves when patients are required to abstain from alcohol before starting treatment, and acamprosate shows better outcomes when detoxification occurs prior to its administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of naltrexone and acamprosate for treating alcohol use disorders: when are these medications most helpful? Maisel, NC., Blodgett, JC., Wilbourne, PL., et al.[2021]

In a qualitative study involving 12 clients with major depressive disorder, those who received positive cognitive behavioral therapy (CBT) preferred it over traditional CBT, reporting a steeper learning curve and greater empowerment.

Positive CBT, which focuses on strengths and positive emotions, effectively counters depressive symptoms and enhances well-being, as clients appreciated its motivating and uplifting approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correction to Geschwind et al. (2020). [2020]

Counselors in addiction treatment are already incorporating positive psychology interventions (PPIs) alongside traditional methods, suggesting a balanced approach to therapy.

While PPIs can help counter negative thoughts and emotions in clients, there are concerns about using them exclusively or without considering individual client needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Counselors' Perspectives of Positive Psychology for the Treatment of Addiction: A Mixed Methods Pilot Study. Krentzman, AR., Barker, SL.[2020]

A meta-analysis of 47 alcohol pharmacotherapy trials revealed significant improvement in the placebo group, with this effect becoming more pronounced in more recent studies.

Factors such as the severity of participants' illness and the frequency of placebo administrations contributed to the magnitude of improvement, but the reasons for the increasing placebo effect over time remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo group improvement in trials of pharmacotherapies for alcohol use disorders: a multivariate meta-analysis examining change over time. Del Re, AC., Maisel, N., Blodgett, JC., et al.[2021]

In a study of 92 alcohol-dependent subjects receiving naltrexone, neuropsychiatric (NP) adverse events significantly decreased study retention, indicating that these side effects may lead to participants dropping out of treatment.

Gastrointestinal (GI) adverse events were found to negatively impact medication compliance, suggesting that these side effects could make patients less likely to take their medication as prescribed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of oral naltrexone: analysis of data from two clinical trials. Oncken, C., Van Kirk, J., Kranzler, HR.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8752639/

Amplification of Positivity Therapy for Co-occurring Alcohol ... The current study examined the feasibility and potential benefit of a behavioral intervention focused on amplification of positivity (AMP) with eight adults.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06030154

NCT06030154 | Amplification of Positivity for Alcohol Use The current study would test the feasibility and acceptability of a 12-session protocol focused on amplification of positivity with populations experiencing ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34253077/

Amplification of Positivity Therapy for Co-occurring Alcohol ... The current study examined the feasibility and potential benefit of a behavioral intervention focused on amplification of positivity (AMP) with ...

4. scholars.okstate.edu scholars.okstate.edu/en/publications/amplification-of-positivity-therapy-for-co-occurring-alcohol-use-

Amplification of Positivity Therapy for Co-occurring Alcohol ... The current study examined the feasibility and potential benefit of a behavioral intervention focused on amplification of positivity (AMP) with eight adults ( ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04934553?tab=table

Amplification of Positivity for Alcohol Use Disorder Co ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

6. withpower.com withpower.com/trial/phase-alcoholism-8-2023-ab753

Amplification of Positivity + Cognitive Behavioral Therapy ... Cognitive Behavioral Therapy (CBT) is generally considered safe for treating substance use disorders, including alcohol use disorder. However, there is no ...