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Attention Control Treatment for Post Traumatic Stress Disorder ׂ(PTSD)

Primary Purpose

PTSD

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Personalized Attention control training (ACT)
Non-personalized Attention control training (ACT)
Control training.
Sponsored by
Tel Aviv University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, attention training, cognitive bias modification

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

  • Tel Aviv University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Personalized ACT

Non personalized ACT

Control training

Arm Description

The personalized attention control training (ACT), comprised of six computerized sessions, in purpose of modulate biases in attention for personalized threat stimuli.

The Non-personalized attention control training (ACT), comprised of six sessions, in purpose of modulate biases in attention for non-personalized threat stimuli.

Computerized control training, comprised of six sessions with a variation of the dot-probe task with neutral stimuli

Outcomes

Primary Outcome Measures

A diagnosis of PTSD and a total score of severity symptoms, as driven from the CAPS-5 interview
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

Total score of the PTSD Checklist (PCL-5).
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).

Full Information

First Posted
October 25, 2016
Last Updated
June 19, 2020
Sponsor
Tel Aviv University
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1. Study Identification

Unique Protocol Identification Number
NCT02945709
Brief Title
Attention Control Treatment for Post Traumatic Stress Disorder ׂ(PTSD)
Official Title
Attention Control Treatment for Post Traumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
PTSD, attention training, cognitive bias modification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personalized ACT
Arm Type
Experimental
Arm Description
The personalized attention control training (ACT), comprised of six computerized sessions, in purpose of modulate biases in attention for personalized threat stimuli.
Arm Title
Non personalized ACT
Arm Type
Active Comparator
Arm Description
The Non-personalized attention control training (ACT), comprised of six sessions, in purpose of modulate biases in attention for non-personalized threat stimuli.
Arm Title
Control training
Arm Type
Placebo Comparator
Arm Description
Computerized control training, comprised of six sessions with a variation of the dot-probe task with neutral stimuli
Intervention Type
Behavioral
Intervention Name(s)
Personalized Attention control training (ACT)
Intervention Description
In this intervention, participants will be trained with a personalized Dot-Probe task. Each participant will perform the task with the set of words that he or she ranked as the most threatening according to a Word Ranking Task.
Intervention Type
Behavioral
Intervention Name(s)
Non-personalized Attention control training (ACT)
Intervention Description
In this intervention, participants will be trained with the same Dot-Probe task as in the personalized condition, except that the word stimuli will be randomly fit for each participant. It should be noted that 25% out of the words in this condition will be high ranked words according to each patient's word ranking. The aim of this is to enhance similarity to a generic ACT intervention (see Badura-Brack et al., 2015), where there is some degree of exposure to what one may consider "personalized" stimuli (i.e., threat words that were randomly included by the researchers), although it is not deliberately set to idiosyncratic preferences.
Intervention Type
Behavioral
Intervention Name(s)
Control training.
Intervention Description
In this intervention, participants will perform a computerized task, similar to the Dot-Probe task. In each trial, one neutral word will be presented at the center of the screen and participants will respond to a probe ('E' or 'f') presented following the removal of the words display. This version does not include the essential ingredients thought to reduce PTSD symptoms in the other dot-probe tasks: exposure to threat content and competition on attentional resources. Thus, this control version provides a control condition for the ACT interventions.
Primary Outcome Measure Information:
Title
A diagnosis of PTSD and a total score of severity symptoms, as driven from the CAPS-5 interview
Description
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).
Time Frame
40 minutes
Secondary Outcome Measure Information:
Title
Total score of the PTSD Checklist (PCL-5).
Description
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).
Time Frame
10 minutes
Other Pre-specified Outcome Measures:
Title
Total score of the PHQ-9
Description
The PHQ-9 , us a 10-item scale for depression symptoms.
Time Frame
10 minutes
Title
The CGI/S
Description
Severity and improvement scales (CGI-S/I; Guy, 1976) will be used to assess participants global clinical condition. The CGI-S and the CGI-I are single-items, clinician-reported, measure assessing severity and improvement of illness using a 7-point Likert-type scale. The CGI-S/I has good inter-rater reliability and concurrent validity with other measures. This tool is widely used in clinical trials concerning psychopathology treatments and has good sensitivity to clinical change (e.g., Berk et al., 2008; Hedges, Brown, & Shwalb, 2009; Kadouri, Corruble, & Falissard, 2007; Leon et al., 1993).
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meeting a current diagnosis of Post-Traumatic Stress Disorder (PTSD) according to DSM-V (American Psychiatric Association, 2013); 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 treatment that is not stabilized in the past 3 months (a stable treatment will not be a reason for exclusion from the study). Pregnancy. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yair Bar-Haim, Prof.
Organizational Affiliation
Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv University
City
Tel Aviv
ZIP/Postal Code
69978
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Weathers, F., Blake, D., Schnurr, P., Kaloupek, D., Marx, B., & Keane, T., The clinician-administered PTSD scale for DSM-5 (CAPS-5). Interview available from the National Center for PTSD at www. ptsd. va. gov, 2013.
Results Reference
background
Citation
American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-5). American Psychiatric Pub, 2013
Results Reference
background
PubMed Identifier
26206075
Citation
Badura-Brack AS, Naim R, Ryan TJ, Levy O, Abend R, Khanna MM, McDermott TJ, Pine DS, Bar-Haim Y. Effect of Attention Training on Attention Bias Variability and PTSD Symptoms: Randomized Controlled Trials in Israeli and U.S. Combat Veterans. Am J Psychiatry. 2015 Dec;172(12):1233-41. doi: 10.1176/appi.ajp.2015.14121578. Epub 2015 Jul 24.
Results Reference
background
Citation
Weathers, F., B. Litz, T. Keane, P. Palmieri, B. Marx, & P. Schnurr, The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www. ptsd. va. gov, 2013.
Results Reference
background

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Attention Control Treatment for Post Traumatic Stress Disorder ׂ(PTSD)

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