Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06030154
Status:
RECRUITING
Last Update Posted:
2024-01-22
First Post:
2023-07-12
Brief Title:
Amplification of Positivity for Alcohol Use
Sponsor:
Laureate Institute for Brain Research Inc
Organization:
Laureate Institute for Brain Research Inc
Study Overview
Official Title:
Developing and Evaluating a Positive Valence Treatment for Alcohol Use Disorder With Anxiety or Depression
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMP-A
Brief Summary:
The proposed study consists of two phases During Phase 1 the investigators will recruit a small sample of participants to complete a psychosocial intervention termed Amplification of Positivity AMP for individuals experiencing comorbid depression or anxiety disorders and alcohol use disorder AMP-A These participants will be asked to provide both qualitative and quantitative input about the AMP-A intervention Based on their input and clinician input the AMP-A manual will be modified for use in Phase 2 The goal is to recruit up to 20 participants in order to ensure there will be at least 8 participants who complete all sessions of AMP-A Phase 2 is a randomized clinical trial RCT protocol in which individuals experiencing comorbid depression or anxiety disorders and alcohol use disorder will be randomized to complete AMP-A or an evidence-based cognitive-behavioral therapy CBT intervention Up to 100 participants will be recruited in order to reach a target of N60 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 functional disability and neural reactivity to reward and alcohol cues during functional magnetic resonance imaging fMRI
Detailed Description:
Substance use disorder including alcohol use disorder is characterized by enhanced neural responsivity to drug alcohol cues but reduced neural responsivity to non-drug reward cues These effects may be exacerbated by comorbid major depressive disorder MDD or symptoms of anhedonia comorbidities which are particularly high amongst alcohol use disorder Response rates for current interventions with alcohol use disorder are rather poor with only 58 experiencing benefits greater than control conditions There is a need to identify interventions that may target reward responsivity in a way that would promote recovery reduce affective disturbance and support better long-term functioning for individuals experiencing alcohol use disorder and comorbid depression and anxiety disorders Positive affect interventions have recently been developed and tested in other populations ie HIV anxietydepression as a way of enhancing positive valence and reward processing These interventions have shown significant promise in these populations but have yet to be examined in the context of alcohol use disorder
The current study would test the feasibility and acceptability of a 12-session protocol focused on amplification of positivity with populations experiencing comorbid alcohol use disorder and depression or anxiety disorders and explore the impact of the intervention on positive affect negative affect alcohol use and craving and neural response patterns during reward and drug cue processing The proposed project would support the final stages of intervention development First an initial pilot study will be conducted to obtain qualitative and quantitative input from N8 participants with Alcohol Use Disorder AUD AnxietyDepression ANXDEP who are asked to engage in the amplification of positivity for AUD intervention AMP-A and their clinicians to inform modifications to the AMP-A manual Then a pilot randomized clinical trial RCT will be conducted in which N60 individuals with Alcohol Use Disorder AUD AnxietyDepression ANXDEP will be randomized to complete the modified AMP-A intervention or a cognitive behavioral therapy CBTintervention Intervention will consist of 12 sessions that may be done virtually or in-person Participation in both phases will include completion of interview-based and self-report measures at pre-treatment weekly during treatment at post-treatment and at 3-month follow-up
The current study would test the feasibility and acceptability of a 12-session protocol focused on amplification of positivity with populations experiencing comorbid alcohol use disorder and depression or anxiety disorders and explore the impact of the intervention on positive affect negative affect alcohol use and craving and neural response patterns during reward and drug cue processing The proposed project would support the final stages of intervention development First an initial pilot study will be conducted to obtain qualitative and quantitative input from N8 participants with Alcohol Use Disorder AUD AnxietyDepression ANXDEP who are asked to engage in the amplification of positivity for AUD intervention AMP-A and their clinicians to inform modifications to the AMP-A manual Then a pilot randomized clinical trial RCT will be conducted in which N60 individuals with Alcohol Use Disorder AUD AnxietyDepression ANXDEP will be randomized to complete the modified AMP-A intervention or a cognitive behavioral therapy CBTintervention Intervention will consist of 12 sessions that may be done virtually or in-person Participation in both phases will include completion of interview-based and self-report measures at pre-treatment weekly during treatment at post-treatment and at 3-month follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34AA030688 | NIH | None | httpsreporternihgovquickSearchR34AA030688 |