Attention Control Treatment for Post Traumatic Stress Disorder ׂ(PTSD)

Not Applicable

Completed

• Conditions: PTSD
• Interventions: Behavioral: Non-personalized Attention control training (ACT); Behavioral: Personalized Attention control training (ACT); Behavioral: Control training.

• Registration Number: NCT02945709
• Lead Sponsor: Tel Aviv University

Brief Summary

The purpose of this study is to explore the efficacy of Attention Control Training for Post Traumatic Stress Disorder (PTSD).

ACT was found to be effective in decreasing attention bias variability and PTSD symptoms in combat veterans (Badura-Brack, et al., 2015). It is now important to continue the examination of ACT's efficacy in additional populations of patients with PTSD. Such extension of treatment to other traumatic experiences raises the question of whether the threatening content of the training material could be personalized for each patient.

Detailed Description

The aim of this study is to explore the efficacy of Attention Control Training for Post Traumatic Stress Disorder (PTSD).

ACT was found to be effective in decreasing attention bias variability and PTSD symptoms in combat veterans (Badura-Brack, et al., 2015). It is now important to continue the examination of ACT's efficacy in additional populations of patients with PTSD. Such extension of treatment to other traumatic experiences raises the question of whether the threatening content of the training material could be personalized for each patient.

For this purpose, we will recruit participants that are diagnosed with PTSD and will be randomly assigned to one of three conditions: personalized ACT, non-personalized ACT, or control training We expect that personalized ACT will produce greater reduction in PTSD symptoms relative to a non-personalized ACT, and that both these conditions will be more effective in symptoms reduction than a control condition not designed to affect attention or expose patients to threat stimuli. We also expect the ACT conditions to reduce attention bias variability relative to the control condition.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-26
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-19
• Last Update Posted: 2020-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Meeting a current diagnosis of Post-Traumatic Stress Disorder (PTSD) according to DSM-V (American Psychiatric Association, 2013);

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Non personalized ACT	Non-personalized Attention control training (ACT)	The Non-personalized attention control training (ACT), comprised of six sessions, in purpose of modulate biases in attention for non-personalized threat stimuli.
Personalized ACT	Personalized Attention control training (ACT)	The personalized attention control training (ACT), comprised of six computerized sessions, in purpose of modulate biases in attention for personalized threat stimuli.
Control training	Control training.	Computerized control training, comprised of six sessions with a variation of the dot-probe task with neutral stimuli

Primary Outcome Measures

Name	Time	Method
A diagnosis of PTSD and a total score of severity symptoms, as driven from the CAPS-5 interview	40 minutes	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 (Weathers, Blake, Schnurr, Kaloupek, Marx, \& Keane, 2013).

Secondary Outcome Measures

Name	Time	Method
Total score of the PTSD Checklist (PCL-5).	10 minutes	The PCL-5, is a 20-item National Center for PTSD Checklist of the Department of Veterans Affairs. Scores can range from 0 to 80, with higher scores reflecting more symptoms of PTSD (Weathers, Litz, Keane, Palmieri, Marx, \& Schnurr, 2013).

Trial Locations

Locations (1)

Tel Aviv University; 🇮🇱 Tel Aviv, Israel