Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Brief Acceptance and Commitment Therapy for HIV-infected At-risk Drinkers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03974061
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Syracuse University

Brief Summary:
Alcohol consumption at hazardous levels is associated with negative consequences on nearly every step of the HIV care continuum. It is a critical factor in HIV treatment that, if unaddressed, significantly contributes to onward transmission and poor treatment outcomes. Alcohol interventions for people living with HIV (PLWH) in the United States (US) have shown mixed results, and no alcohol intervention for PLHW has shown long-term reductions in heavy drinking or a significant impact on HIV-related outcomes. One hypothesized reason for this limited success is the failure of these interventions to address the multiple overlapping problems (e.g., comorbid mental health conditions, behavioral health needs) of PLWH who are hazardous drinkers. Innovative alcohol intervention strategies that can have an impact on these multiple behavioral health needs, in a format that can be feasibly delivered in the context of HIV care, are needed. Brief Acceptance and Commitment Therapy (ACT) is a promising intervention for HIV-infected hazardous drinkers. ACT is a transdiagnostic treatment that uses mindfulness skills and values-guided behavioral action plans to impact a broad array of psychological symptoms. ACT has shown efficacy for treatment of anxiety, depression, chronic pain, and substance use, making it a promising approach for hazardous drinkers. The overall objective of this application is to adapt an existing brief ACT intervention developed for smoking cessation, and pilot test its feasibility and acceptability for PLWH who are hazardous drinkers. We hypothesize that the resulting intervention will be preliminarily associated with decreased alcohol use, improved ART adherence, decreased symptoms of depression, anxiety, and drug use, and increased acceptance—a known mechanism of change in ACT.

Condition or disease Intervention/treatment Phase
Treatment Behavioral: Brief Acceptance and Commitment Therapy Behavioral: Brief Alcohol Intervention Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized (stratified by gender) to a treatment condition (brief acceptance and commitment therapy or a brief alcohol intervention) and an interventionist.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will be blinded to which intervention is hypothesized to be superior and produce the intended effects. Outcome assessors will be blinded to which intervention participants received.
Primary Purpose: Treatment
Official Title: Brief Acceptance and Commitment Therapy for HIV-infected At-risk Drinkers
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : November 28, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Brief Acceptance and Commitment Therapy
Participants randomized to the Acceptance and Commitment Therapy (ACT) arm will receive 6-weekly 30-minute ACT intervention sessions delivered via telephone.
Behavioral: Brief Acceptance and Commitment Therapy
Acceptance and Commitment Therapy utilizes mindfulness skills and values-guided behavioral action plans to decrease experiential avoidance and impact a broad array of psychological symptoms.
Other Name: Brief ACT

Active Comparator: Brief Alcohol Intervention
Participants randomized to the Brief Alcohol Intervention (BI) will receive two 20-minute sessions of a brief alcohol intervention delivered via telephone, two 10-minute booster calls, and a 5-minute reminder phone call for the post-treatment appointment.
Behavioral: Brief Alcohol Intervention
The Brief Alcohol Intervention is a standard intervention that will be adapted for men and women living with HIV. The intervention will be matched in frequency and length to the brief ACT intervention.
Other Name: BI




Primary Outcome Measures :
  1. Change in alcohol consumption from baseline to 7-weeks post-treatment [ Time Frame: Change in alcohol consumption will be measured via the TLFB from baseline to end of treatment at 7-weeks. ]
    Alcohol consumption will be measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields the following: number of drinks per drinking day, number of heavy drinking (>3 for women; >4 for men) episodes, and number of drinking days over the last 42-day period.

  2. Change in alcohol consumption from 7-weeks post-treatment to 3-months post-baseline [ Time Frame: Change in alcohol consumption will be measured via the TLFB from 7-weeks post-treatment to 3-months post-baseline. ]
    Alcohol consumption will be measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields the following: number of drinks per drinking day, number of heavy drinking (>3 for women; >4 for men) episodes, and number of drinking days over the last 42-day period.

  3. Change in alcohol consumption from 3-months post-baseline to 6-months post-baseline [ Time Frame: Change in alcohol consumption will be measured via the TLFB from 3-months post-baseline to 6-months post-baseline. ]
    Alcohol consumption will be measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields the following: number of drinks per drinking day, number of heavy drinking (>3 for women; >4 for men) episodes, and number of drinking days over the last 42-day period.

  4. Change in alcohol consumption from baseline to 6-months post-baseline [ Time Frame: Change in alcohol consumption will be measured via PEth from baseline to 6-months post-baseline. ]
    Alcohol use will also be assessed using the biomarker phosphatidylethanol (PEth). PEth is an abnormal phospholipid formed only in the presence of alcohol with an estimated half-life of 4-12 days and can be measured from dried blood spots.

  5. Change in ART adherence from baseline to 7-weeks post-treatment [ Time Frame: Change in ART adherence will be measured via VAS from baseline to end of treatment at 7-weeks. ]
    Adherence will be measured by self-report via the validated visual analog scale (VAS) to identify participants will optimal (>95%) versus suboptimal (<95%) adherence. The VAS asks participants to point to the place on a line ranging from 0-100% that best represents how much of their ART medication that they have taken in the last month.

  6. Change in ART adherence from 7-weeks post-treatment to 3-months post-baseline [ Time Frame: Change in ART adherence will be measured via VAS from 7-weeks post-treatment to 3-months post-baseline. ]
    Adherence will be measured by self-report via the validated visual analog scale (VAS) to identify participants will optimal (>95%) versus suboptimal (<95%) adherence. The VAS asks participants to point to the place on a line ranging from 0-100% that best represents how much of their ART medication that they have taken in the last month.

  7. Change in ART adherence from 3-months post-baseline to 6-months post-baseline [ Time Frame: Change in ART adherence will be measured via VAS from 3-months post-baseline to 6-months post-baseline. ]
    Adherence will be measured by self-report via the validated visual analog scale (VAS) to identify participants will optimal (>95%) versus suboptimal (<95%) adherence. The VAS asks participants to point to the place on a line ranging from 0-100% that best represents how much of their ART medication that they have taken in the last month.

  8. Change in ART adherence from baseline to 6-months post-baseline [ Time Frame: Change in ART adherence will be measured via ARV levels in hair from baseline to 6-months post-baseline. ]
    Adherence will also be measured via ARV levels in hair. Hair concentrations of ARVs have been shown to be the strongest independent predictor of virological success in prospective cohorts of HIV-infected patients.


Secondary Outcome Measures :
  1. Acceptance [ Time Frame: Acceptance will be measured at baseline, 7-weeks post-baseline, and 3 and 6-month follow-ups. ]
    Acceptance will be measured using the total score obtained via the self-report Brief Experiential Avoidance Questionnaire (BEAQ). The BEAQ is a 15-item measures that assesses six domains of experiential avoidance: behavioral avoidance, distress aversion, procrastination, distraction, repression/denial and distress endurance.

  2. Symptoms of Depression [ Time Frame: Symptoms of depression will be measured at baseline, 7-weeks post-baseline, and 3 and 6-month follow-ups. ]
    Symptoms of depression will be measured using the total score obtained via the self-report Patient Health Questionnaire (PHQ)-9. The PHQ-9 is a 10-item standardized measure of depression severity.

  3. Symptoms of Anxiety [ Time Frame: Symptoms of anxiety will be measured at baseline, 7-weeks post-baseline, 3 and 6-month follow-ups. ]
    Symptoms of anxiety will be measured using the total score obtained via the self-report Generalized Anxiety Disorder 7-item (GAD-7). The GAD-7 is a 7-item standardized measure of anxiety severity.

  4. Substance Use [ Time Frame: Substance use will be measured at baseline, 7-weeks post-baseline, and 3 and 6-month follow-ups ]
    Substance use will be measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields the number of days non-prescription drugs were used.


Other Outcome Measures:
  1. Chronic Pain [ Time Frame: Pain will be measured at baseline, 7-weeks post-baseline, 3 and 6-month follow-ups. ]
    Pain will be measured using the total score obtained via the self-report brief Graded Chronic Pain Scale (GCPS-PCS). The GCPS-CPS is a 3-item measure that yields both continuous and categorical outcomes of pain.

  2. HIV Medication Adherence Self-Efficacy [ Time Frame: HIV Medication Adherence Self-Efficacy will be measured at baseline, 7-weeks post-baseline, 3 and 6-month follow-ups. ]
    HIV Medication Adherence Self-Efficacy will be measured using the total score obtained via the self-report HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). The HIV-ASES is a 12-item measure of one's confidence in their ability to adhere to a treatment plan.

  3. Alcohol-Related Problems [ Time Frame: Alcohol-related problems will be measured at baseline, 7-weeks post-baseline, 3 and 6-month follow-ups. ]
    Alcohol-related problems will be measured using the total score obtained from the Short Inventory of Problems (SIP-2L). The SIP-2L is a 15-item measure that assesses negative consequences of alcohol use.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥18 years of age,
  2. HIV-positive,
  3. currently prescribed ART medication,
  4. score of ≥4 (men) or ≥3 (women) on the AUDIT-C.

Exclusion Criteria:

  1. Experiencing acute illness or declining health status when it is determined by a treatment provider that research participation is contraindicated,
  2. unable to understand spoken English,
  3. does not own a cell phone,
  4. a score of 12 on the AUDIT-C, indicating high risk for a severe alcohol use disorder,
  5. a score of ≥20 on the PHQ-9 indicating severe depressive symptoms,
  6. a score of ≥15 on the GAD-7, indicating severe symptoms of anxiety,
  7. experiencing active psychosis as judged by research staff via scores on the BSI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974061


Contacts
Layout table for location contacts
Contact: Sarah E Woolf-King, PhD 315-443-9917 sewoolf@syr.edu
Contact: Stephen A Maisto, PhD 315-443-2334 samaisto@syr.edu

Sponsors and Collaborators
Syracuse University
Investigators
Layout table for investigator information
Principal Investigator: Sarah E Woolf-King, PhD Syracuse University
Principal Investigator: Stephen A Maisto, PhD Syracuse University
  Study Documents (Full-Text)

Documents provided by Syracuse University:
Informed Consent Form  [PDF] February 9, 2019


Layout table for additonal information
Responsible Party: Syracuse University
ClinicalTrials.gov Identifier: NCT03974061     History of Changes
Other Study ID Numbers: 17-278
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The proposed pilot randomized clinical trail (RCT) will include data from approximately 74 HIV-infected hazardous drinkers recruited from a single HIV clinic. The final dataset will include self-reported demographic and behavioral data related to substance use, HIV medication adherence, and general mental health functioning as well as laboratory data from dried blood spots and hair analysis. We will be collecting identifying information in a separate database to track participants for followup appointments. Even though the final computerized dataset will be stripped of all personal identifiers, given the small sample of the study, and the sole recruitment source, there remains a possibility of deductive disclosure of research participants with unusual characteristics. We will thus make the data and associated documentation available to users only via a signed data-sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data sharing will be available upon publication of the main study findings.
Access Criteria: We will make the data and associated documentation available to users only via a signed data-sharing agreement that stipulates a commitment to: (1) only use the data for research purposes and not to identify any individual participants, (2) securely storing the data via password-protected databases and secure servers, and (3) destroying or returning the data after analyses are completed.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Syracuse University:
Brief Acceptance and Commitment Therapy
HIV
Alcohol
Randomized Controlled Trial

Additional relevant MeSH terms:
Layout table for MeSH terms
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs