Skip to main content
Clinical Trials/NCT04228133
NCT04228133
Completed
Not Applicable

Home-Delivered Attention Control Training for Post Traumatic Stress Disorder: A Randomized Controlled Trial

Tel Aviv University1 site in 1 country60 target enrollmentJanuary 1, 2020
ConditionsPTSD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PTSD
Sponsor
Tel Aviv University
Enrollment
60
Locations
1
Primary Endpoint
Change from baseline of the total severity score of the CAPS-5 interview
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The aim of the study is to explore the efficacy of home-delivered Attention Control Training (ACT) for Posttraumatic Stress Disorder (PTSD).

Three randomized controlled trials have shown that attention bias modification protocols applying attention control training (ACT) aimed to balance attention between threat-related and neutral stimuli are efficient in reducing PTSD symptoms. However, contrary to in-clinic administration, such as applied in the above mentioned studies, home-delivered attention bias modification was not effective in reducing symptoms among treatment-seeking patients.

It is crucial to continue examining the efficacy of home-delivered ACT as PTSD entails functional impairments that might impede treatment-seeking patients from reaching to clinics to receive treatment. This could also inform other ABM protocols designated to treat other disorders.

Detailed Description

The aim of the study is to explore the efficacy of home-delivered Attention Control Training (ACT) for Posttraumatic Stress Disorder (PTSD). Three randomized controlled trials have shown that attention bias modification (ABM) protocols applying attention control training (ACT) aimed to balance attention between threat-related and neutral stimuli are efficient in reducing PTSD symptoms. However, contrary to in-clinic administration, such as applied in the above mentioned studies, home-delivered ABM was not effective in reducing symptoms among treatment-seeking patients. It is crucial to continue examining the efficacy of home-delivered ACT as PTSD entails functional impairments that might impede treatment-seeking patients from reaching to clinics to receive treatment. This could also inform other ABM protocols designated to treat other disorders. To overcome some critical differences between home and lab environments, the investigators developed a home-delivered ACT protocol that resembles as much as possible the typical-in-lab protocol. Specifically, participants will be accompanied during their training sessions using internet-based video conference, permitting a better control for the physical environment before and during the session and a direct interaction with the experimenters. To test its efficacy, the investigators will recruit participants that are diagnosed with PTSD and will be randomly assigned to one of two home-delivered conditions: ACT and a control ABM condition. It is hypothesized that home-delivered ACT will produce greater reduction in PTSD symptoms relative to a control ABM protocol. It is also expected that ACT will reduce attention bias variability to a greater extent compared to the control condition.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
April 5, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yair Bar-Haim

Professor of Psychology and Neuroscience School of Psychological Sciences Sagol School of Neuroscience Tel Aviv University

Tel Aviv University

Eligibility Criteria

Inclusion Criteria

  • Meeting a current diagnosis of Post-Traumatic Stress Disorder (PTSD) according to DSM-V (American Psychiatric Association, 2013);
  • Having a home PC with internet access, web cam, microphone and speakers. Operation system must be windows 7 or a newer version.

Exclusion Criteria

  • A diagnosis of psychotic or bipolar disorders.
  • A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
  • Suicidal ideation.
  • Drugs or alcohol abuse.
  • Non-fluent Hebrew.
  • A pharmacological or psychotherapy treatment that is not stabilized in the past 3 months (a stable treatment will not be a reason for exclusion from the study).

Outcomes

Primary Outcomes

Change from baseline of the total severity score of the CAPS-5 interview

Time Frame: up to 2 weeks pre-treatment and 1-2 weeks post-treatment

The Clinician Administered PTSD Scale (CAPS-5), is a structured interview that will be used to make a diagnosis of PTSD according to the DSM-V criteria. This interview is consists of 30 items regarding the frequency and intensity of PTSD symptoms and a total score of severity is been rated, with higher scores denoting higher symptom severity.

Secondary Outcomes

  • Change from baseline of the total score of the PTSD Checklist (PCL-5)(up to 2 weeks pre-treatment and 1-2 weeks post-treatment)

Study Sites (1)

Loading locations...

Similar Trials