Accelerated Resolution Therapy for HIV Positive African, Caribbean and Black

NCT03649607 | Unknown DMC

• 1 other identifier: 18028
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Nearly two-thirds of ACB people living in Ontario are classified as immigrant, refugee or undocumented \[non-status/NS\] (IRNS) individuals. IRNS people are more likely than the general population to be exposed to events that are associated with posttraumatic stress disorder (PTSD). Furthermore, the diagnosis of HIV is itself a traumatic life event. Nonetheless, significant gaps remain regarding the best strategies for supporting trauma-informed care among ACB IRNS individuals with HIV. Accelerated Resolution Therapy (ARTh) is an exposure-based therapy that incorporates rapid eye movements in a standardized administration over 1-5 sessions. ARTh is an effective brief treatment for PTSD symptoms; but, it's range of therapeutic benefit when applied to people with co-morbid HIV infections is unknown. No studies have leveraged neuroimaging to validate the self-reported empirical therapeutic benefit of ARTh. The investigators propose to investigate the implementation of ARTh, including understanding factors influencing its therapeutic outcomes. The three specific aims of this study are to (1) identify factors influencing the response to ARTh (2) identity neuroimaging indicators for treatment effects of ARTh, and (3) to identify factors influencing ARTh implementation. The investigators will conduct a pre-/post- evaluation of intervention outcomes of ARTh implemented in a sample (n=40) of HIV-positive ACB IRNS ages 18-45 years (Aim 1). The investigators will use statistical analyses to identify factors that may moderate the treatment response of ARTh on PTSD symptoms, HIV symptoms distress and quality of life (Aim 1). The investigators will use diffusion tensor imaging and resting state functional magnetic resonance imaging (fMRI) metrics to assess structural and functional connectivity and examine their associations with PTSD symptoms and HIV symptom distress (Aim 2). Finally, the investigators will use process measures to study two specific implementation factors (acceptability and appropriateness) regarding ARTh use in this population. As a consequence of this research, the investigators expect to generate data that will be used to refine an ARTh implementation protocol that will be integrated into an adaptive implementation trial to reduce gaps in the HIV care continuum through the use of intervention packages for ACB people customized to the individual's needs.

Conditions

HIV; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• HIV Symptom Distress Scale (SDS).

  This 20-item instrument is used to measure overall HIV symptom frequency, distress and clinically relevant clusters. Participants are asked to indicate which of the 20 symptoms they have experienced in the past 2 weeks. Participants are then asked to rate symptom that are present, on the extent to which the symptoms are bothersome (0=do not have symptom; 25=have symptom, but no bother; 50=have symptom, little bother; 75=have symptom, bothers me some; 100= have symptom, bothers me a lot). Scores range from 0 to 100. Higher scores indicate greater symptom distress.

  Symptom distress score 60 days post the study start date.

Secondary Outcomes (2)

• HIV Associated Neurocognitive Disease (HAND).

  Composite Z-score 60 days post the study start date.

• Working and learning memory

  Composite Z-score 60 days post the study start date.

Other Outcomes (3)

• HIV Viral Load

  Number of viral particles per ml of plasma 60 days post the study start date.

• Post Traumatic Stress Disorder (PTSD) Checklist - Civilian Version (PCL-5)

  Posttraumatic stress score 60 days post the study start date.

• HIV/AIDS Related Quality of Life

  Quality of life measure 60 days post the study start date.

Study Arms (1)

Accelerated Resolution Therapy

OTHER

Participants will complete a clinical intake assessment before meeting with the therapist and initiating the ART® protocol. Participants will receive the ART intervention over a 21-day period, where imaginal exposure and imagery re-scripting will be used replace previous traumatic experiences. The ART intervention will be assessed through pre- and post-test measures at 60-days post enrolment.

Other: Accelerated Resolution Therapy

Interventions

Accelerated Resolution Therapy OTHER

ART was developed to treat both physiological and cognitive aspects of PTSD, which has been described as a consequence of failed memory processing. The use of Voluntary Image Replacement (VIR) parallels imaging re-scripting in which a preexisting negative mental image is transformed into a more benign image. This has been successfully used to treat survivors of traumatic industrial accidents suffering from PTSD. Participants will complete five sessions over a 21-day period.

Accelerated Resolution Therapy

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• A person will be eligible for study participation if they:
• identify as Black African, Caribbean and/or Canadian
• are able to consent to participate/have capacity to consent
• have previously been diagnosed with HIV
• score \>33 on the PTSD Checklist - Civilian (PCL-5)
• currently live in the Greater Toronto metropolitan area
• can speak and understand either English or French
• are on stable combination antiretroviral therapy for the past six months or more

You may not qualify if:

• A person will be excluded from this study if they meet any of the following conditions:
• born in Canada
• unable to consent to provide documentation of HIV seropositive status
• unable to consent to an MRI, including intolerance due to claustrophobia
• are older than 50 years old.
• have a major psychiatric disorder likely to impede treatment (e.g. psychosis), current suicidal ideation, current treatment for substance addiction, or diagnosis of eye movement disorder.
• chronic seizures, stroke not consistent with cerebral small vessel disease (CSVD), head trauma resulting in loss of consciousness \>30 min, and multiple sclerosis.
• brain infection (except for HIV-1), including any fungal meningitis, toxoplasmosis, progressive multifocal leukoencephalopathy. Subjects with any space-occupying brain lesions requiring acute or chronic therapy, for example Central nervous system (CNS) lymphoma, will be excluded from participation.
• metallic implant, e.g., in skull, cardiac devices that do not meet safety standards for MRI

Sponsors & Collaborators

• Unity Health Toronto: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• LaRon Nelson, PhD, RN, FNP

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal Djiadeu, PhD

CONTACT

4168646060; djiadeup@smh.ca

LLana James

CONTACT

4167164771; jamesll@smh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: August 28, 2018
• Study Start: September 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: August 1, 2020
• Last Updated: April 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share