Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648629
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Acceptance and Commitment Therapy for HIV Hazardous Drinkers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Acceptance and Commitment Therapy for HIV Hazardous Drinkers a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Alcohol consumption is a critical factor in HIV treatment that significantly contributes to poor treatment-related outcomes Randomized clinical trials RCTs of alcohol interventions for people with HIV PWH have had limited success perhaps due to an increasingly recognized co-morbitity of co-occurring hazardous alcohol use and other mental health-related problems among PWH This has necessitated a shift in the literature towards trans-diagnostic approaches that target core psychological processes that underlie multiple mental health-related problems One trans-diagnostic mechanism that is relevant to alcohol and other substance use is experiential avoidance EA- ie repeated and maladaptive use of substances andor other behaviors to escape or avoid unwanted thoughts feelings andor urges Acceptance and commitment therapy ACT targets EA and is an empirically supported treatment for multiple psychological and behavioral health-related outcomes however there have not been any full-scale RCTs of ACT for alcohol use among any population including PWH The investigators recently adapted a telephone-delivered ACT intervention originally developed for smoking cessation into an intervention for PWH who drink at unhealthy levels NIHNIAAA R34AA026246 This six-session telephone-delivered ACT intervention for alcohol use showed high feasibility and acceptability in a pilot RCT conducted by our team The overall objective of this application is therefore to determine if ACT can significantly reduce alcohol use and comorbid symptoms of depression anxiety and stress among adult PWH who drink at unhealthy levels The specific aims are To determine the relative efficacy of ACT compared to BI for reducing alcohol use among PWH Aim 1 and to determine if ACT has an effect on trans-diagnostic processes that in turn affect alcohol use and other psychological and functional outcomes Aim 2 The investigators will accomplish these aims by conducting a remote RCT in which the investigators randomly assign 300 PWH who drink at unhealthy levels to either the ACT intervention the investigators developed n 150 or a BI intervention n 150 previously shown to reduce alcohol use among PWH The investigators will assess alcohol-related outcomes-via self-report and a biomarker- at baseline post-treatment 7 weeks post-baseline and again 3- 6- and 12-months post-randomization The investigators will also measure EA to determine if it mediates treatment effects for alcohol use and other psychological and functional outcomes measured at all timepoints
Detailed Description:
Alcohol use has a substantial impact on HIV care Sixty-seven percent of people with HIV PWH report using alcohol in the previous year 27-40 report drinking at unhealthy levels and 30 meet criteria for alcohol use disorder AUD PWH who are unhealthy drinkers compared to those who abstain or drink relatively less experience a significant increase in risk for mortality lack of viral suppression less antiretroviral therapy ART utilization and sub-optimal adherence to ART Unhealthy alcohol consumption has been found to affect nearly every stage of the HIV care continuum making it a critical factor in HIV treatment
Randomized clinical trials RCTs of alcohol interventions for PWH have had limited success likely due to lack of attention to co-morbid mental health problems There have been several reviews of this literature the most recent of which identified 9 non-overlapping behavioral trials developed specifically to target alcohol use and conducted in the US with adult samples of PWH Only four of these nine trials resulted in significant effects on alcohol-related outcomes and only two trials had effects on alcohol-related outcomes that were significantly different from the control group at 12-month follow-up One hypothesized reason for this limited success is an increasingly recognized comorbidity of co-occurring unhealthy alcohol use and other mental health-related problems among PWH Indeed up to 63 of PWH meet criteria for both a substance use disorder and another psychiatric disorder-necessitating a shift in the literature towards trans-diagnostic approaches that target core psychological processes that underlie multiple mental health and substance-related problems One trans-diagnostic mechanism that is particularly relevant to alcohol and other substance use is experiential avoidance EA- ie repeated and maladaptive use of substances andor other behaviors to escape or avoid unwanted thoughts feelings andor urges
Acceptance and commitment therapy ACT is a promising trans-diagnostic intervention for PWH
ACT is a trans-diagnostic treatment that targets experiential avoidance as an underlying factor common to mental and behavioral health problems Mindfulness skills and values-guided behavioral action plans are used to decrease experiential avoidance and impact a broad array of psychological symptoms via improved psychological acceptance A recent review of 20 meta-analyses based on 133 studies found ACT to be efficacious across multiple psychological and behavioral health-related outcomes including depression anxiety chronic pain stress and trans-diagnostic combinations of conditions Additionally three meta- analyses have found ACT to be efficacious for smoking and other drug use and there is an emerging literature suggesting ACT is a promising approach for alcohol use There have not however been any full- scale RCTs of ACT for alcohol use among any population including PWH Given ACTs potential to improve multiple psychological and alcohol-related problems simultaneously it holds great promise as an intervention for PWH who are unhealthy drinkers The investigators recently adapted a telephone-delivered ACT intervention originally developed for smoking cessation into an intervention for PWH who drink at unhealthy levels NIHNIAAA R34AA026246 With a multidisciplinary team and with two rounds of input from PWH the investigators developed a six- session telephone-delivered ACT intervention for alcohol use and subsequently conducted a pilot feasibilityacceptability RCT The investigators found high acceptability of the adapted ACT intervention and evidence of feasibility for conducting a full-scale remote RCT
The overall objective of this application is therefore to determine the relative efficacy of ACT compared to a standard Brief Alcohol Intervention BI for reducing alcohol use and comorbid symptoms of depression anxiety and stress among adult PWH who are unhealthy drinkers The applications specific aims are to
Aim 1 Determine the relative efficacy of ACT compared to BI for reducing alcohol use among PWH
To achieve this aim the investigators will conduct a fully remote relative efficacy RCT The investigators will randomly assign 300 PWH who are unhealthy drinkers to either the ACT intervention the investigators developed n 150 or a BI intervention n 150 previously shown to reduce alcohol use among PWH The investigators will assess alcohol-related outcomes-via self-report and an objective biomarker phosphatidylethanol - at baseline post-treatment 7 weeks post-baseline and again 3- 6- and 12-months post-randomization The investigators hypothesize that the two treatments will have significant and statistically equivalent effects on alcohol use at post-treatment and 3-months H1 and consistent with a sleeper effect for ACT the ACT condition will have superior alcohol outcomes at 6- and 12-months post- randomization H2
Aim 2 Determine if ACT has an effect on trans-diagnostic processes that in turn affect alcohol use and other psychological and functional outcomes To achieve this aim the investigators will measure EA and determine if it mediates treatment effects for alcohol use and other psychological and functional outcomes The investigators hypothesize that ACT will have superior outcomes on stress anxiety depression and functional outcomes at all follow-up timepoints H3 and that EA will be a significant mediator of all treatment effects including alcohol use H4
Randomized clinical trials RCTs of alcohol interventions for PWH have had limited success likely due to lack of attention to co-morbid mental health problems There have been several reviews of this literature the most recent of which identified 9 non-overlapping behavioral trials developed specifically to target alcohol use and conducted in the US with adult samples of PWH Only four of these nine trials resulted in significant effects on alcohol-related outcomes and only two trials had effects on alcohol-related outcomes that were significantly different from the control group at 12-month follow-up One hypothesized reason for this limited success is an increasingly recognized comorbidity of co-occurring unhealthy alcohol use and other mental health-related problems among PWH Indeed up to 63 of PWH meet criteria for both a substance use disorder and another psychiatric disorder-necessitating a shift in the literature towards trans-diagnostic approaches that target core psychological processes that underlie multiple mental health and substance-related problems One trans-diagnostic mechanism that is particularly relevant to alcohol and other substance use is experiential avoidance EA- ie repeated and maladaptive use of substances andor other behaviors to escape or avoid unwanted thoughts feelings andor urges
Acceptance and commitment therapy ACT is a promising trans-diagnostic intervention for PWH
ACT is a trans-diagnostic treatment that targets experiential avoidance as an underlying factor common to mental and behavioral health problems Mindfulness skills and values-guided behavioral action plans are used to decrease experiential avoidance and impact a broad array of psychological symptoms via improved psychological acceptance A recent review of 20 meta-analyses based on 133 studies found ACT to be efficacious across multiple psychological and behavioral health-related outcomes including depression anxiety chronic pain stress and trans-diagnostic combinations of conditions Additionally three meta- analyses have found ACT to be efficacious for smoking and other drug use and there is an emerging literature suggesting ACT is a promising approach for alcohol use There have not however been any full- scale RCTs of ACT for alcohol use among any population including PWH Given ACTs potential to improve multiple psychological and alcohol-related problems simultaneously it holds great promise as an intervention for PWH who are unhealthy drinkers The investigators recently adapted a telephone-delivered ACT intervention originally developed for smoking cessation into an intervention for PWH who drink at unhealthy levels NIHNIAAA R34AA026246 With a multidisciplinary team and with two rounds of input from PWH the investigators developed a six- session telephone-delivered ACT intervention for alcohol use and subsequently conducted a pilot feasibilityacceptability RCT The investigators found high acceptability of the adapted ACT intervention and evidence of feasibility for conducting a full-scale remote RCT
The overall objective of this application is therefore to determine the relative efficacy of ACT compared to a standard Brief Alcohol Intervention BI for reducing alcohol use and comorbid symptoms of depression anxiety and stress among adult PWH who are unhealthy drinkers The applications specific aims are to
Aim 1 Determine the relative efficacy of ACT compared to BI for reducing alcohol use among PWH
To achieve this aim the investigators will conduct a fully remote relative efficacy RCT The investigators will randomly assign 300 PWH who are unhealthy drinkers to either the ACT intervention the investigators developed n 150 or a BI intervention n 150 previously shown to reduce alcohol use among PWH The investigators will assess alcohol-related outcomes-via self-report and an objective biomarker phosphatidylethanol - at baseline post-treatment 7 weeks post-baseline and again 3- 6- and 12-months post-randomization The investigators hypothesize that the two treatments will have significant and statistically equivalent effects on alcohol use at post-treatment and 3-months H1 and consistent with a sleeper effect for ACT the ACT condition will have superior alcohol outcomes at 6- and 12-months post- randomization H2
Aim 2 Determine if ACT has an effect on trans-diagnostic processes that in turn affect alcohol use and other psychological and functional outcomes To achieve this aim the investigators will measure EA and determine if it mediates treatment effects for alcohol use and other psychological and functional outcomes The investigators hypothesize that ACT will have superior outcomes on stress anxiety depression and functional outcomes at all follow-up timepoints H3 and that EA will be a significant mediator of all treatment effects including alcohol use H4
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None