Accelerated Resolution Therapy for HIV Positive African, Caribbean and Black
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|ClinicalTrials.gov Identifier: NCT03649607|
Recruitment Status : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : April 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV Post Traumatic Stress Disorder||Other: Accelerated Resolution Therapy||Not Applicable|
STUDY OVERVIEW - PURPOSE AND BACKGROUND
African, Caribbean and Black (ACB) individuals represent only 4.7% of Ontario's population, yet account for 30% of HIV prevalence in the province. Nearly two-thirds of ACB people living in Ontario are classified as immigrant, refugee or non-status (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. For example, IRNS women are more likely than Canadian-born women to have experienced rape, non-sexual physical assault, and civil conflict. ACB IRNS men who have sex with men (MSM) are more likely than non-MSM to have emigrated to Canada as asylum-seekers after fleeing some form of persecution or imminent threat in their countries of origin. Furthermore, while it is known that stigma contributes to exacerbation and severity of HIV symptoms—via the activation of physiological stress responses—there is no known intervention that has been shown to interrupt the pathway by which HIV stigma effects stress and HIV symptoms. Accelerated Resolution Therapy (ART®) is an exposure-based therapy that incorporates rapid eye movements in a standardized administration over 5 sessions in a 3-week period. ART® is effective brief treatment for PTSD symptoms; but, it's range of therapeutic benefit when applied to people with HIV infections is unknown. Although evidence shows that the amygdala is the brain region most reactive to changes in stress stimuli, it remains unknown if therapeutic responses can be reliably validated with biomarkers. No studies have leveraged neuroimaging to validate the self-reported empirical therapeutic benefit of ART®.
The purpose of this study is to investigate the implementation of ART®, including understanding factors influencing its therapeutic outcomes.
The central hypothesis is that ART® will reduce HIV symptom distress by down-modulating the effects of stigma and posttraumatic stress—leading to improved self-reported quality of life. The hypothesis is based on previous research showing that adaptive coping strategies buffer the effects of stigma on stress, as well as evidence from a randomized trial of ART® which demonstrated statistically significant treatment effects for trauma related distress (d=1.88), anxiety (d=1.62), and depression (d=1.41), as well as a clinically meaningful 23-point reduction on the civilian PTSD checklist. The investigators will investigate our central hypothesis by pursuing the following specific aims in a sample of ACB immigrant, refugee and non-status people with HIV.
- Identify factors influencing the response to ART®
- Identity neuroimaging indicators for treatment effects of ART®
- Identify factors influencing ART® implementation
The secondary purpose of this study is to determine if ART® treatment of posttraumatic stress symptoms can decrease inflammation and its effects on HIV symptoms.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Implementation Trial of Accelerated Resolution Therapy for Treatment of Post-Traumatic Stress in HIV Positive Immigrant, Refugee and Undocumented Africans, Caribbean and Black Canadians|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||August 2020|
Accelerated Resolution Therapy
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
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.
- HIV Symptom Distress Scale (SDS). [ Time Frame: Symptom distress score 60 days post the study start date. ]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.
- HIV Associated Neurocognitive Disease (HAND). [ Time Frame: Composite Z-score 60 days post the study start date. ]
The HAND assessment includes a battery of measures commonly used to evaluate neurocognitive functioning in 6 domains: executive function, speed of information processing, attention and working memory, and learning memory. The neurocognitive evaluation will be performed by trained staff and supervised by Dr. Adwoa Agyei with consultation from Dr. Giovanni Schifitto.
The assessment will include tests of:
- Executive Function using "Trailmaking Test Part B, Stroop Interference task"
- Speed of Information Processing using "Symbol Digit Modalities Test and Stroop Color Naming"
- Attention Memory using "CalCAP(CRT4) and WAIS-III Letter-Number Sequencing"
- Working and learning memory [ Time Frame: Composite Z-score 60 days post the study start date. ]
Patient's learning and working memory will be assessed using the following tests: Rey Complex Figure Test Immediate Recall, Rey Auditory Verbal Learning, Test RAVLT Delayed Recall, Rey Complex Figure Test Delayed Recall.
The working and memory test will be part of the HAND assessment.
- HIV Viral Load [ Time Frame: Number of viral particles per ml of plasma 60 days post the study start date. ]The investigators will assess the volume of HIV in serum measured using reverse transcriptase polymerase chain reaction (RT PCR). The HIV viral load is a measure of the number of viral particles per ml of plasma. Higher numbers of HIV viral copies indicate inadequate viral suppression and insufficient immune function. The data will be entered directly into REDCap by the St. Michael's Hospital lab personnel. The investigators will code viral suppression as <50 HIV copies/mL of blood as "=yes" and ≥50 "=no."
- Post Traumatic Stress Disorder (PTSD) Checklist - Civilian Version (PCL-5) [ Time Frame: Posttraumatic stress score 60 days post the study start date. ]This 20-item measure assesses symptoms of posttraumatic stress. It assesses an individual's symptoms based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for PTSD. The PCL-5 focuses on four aspects of distressing memories: re-experiencing the event, avoidance, mitigation and hyperarousal. The scale uses a 5-point Likert scale that ranges from 0 to 4 (0 [Not at all]; 1[A little bit]; 2 [Moderately]; 3 [Quite a bit]; 4 [Extremely]) to rate each of the 20 items on the degree to which symptoms were present and bothersome in the prior 30-days. For PTSD diagnosis, the score must be above certain cut-point indicating moderate to high symptom severity. The PCL-5 showed good internal consistency in a study with HIV-positive patients in Ghana (α=0.79).
- HIV/AIDS Related Quality of Life [ Time Frame: Quality of life measure 60 days post the study start date. ]There is a 34-item tool that measures experiences in overall function, life satisfaction, health and financial worries, worries about medication, HIV disclosure, living with HIV and doctor satisfaction in the past month. Check boxes to 5 specific answers (All the time; A lot of the time; Some of the time; A little of the time; None of the time) are used to measure and evaluate quality of life.
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): NCT03649607
|Contact: Pascal Djiadeu, PhD||4168646060 ext firstname.lastname@example.org|
|Contact: LLana Jamesemail@example.com|
|Principal Investigator:||LaRon Nelson, PhD, RN, FNP||St. Michael's Hospital, Toronto|