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Attention Control Treatment for Post Traumatic Stress Disorder ׂ(PTSD)

Attention Control Treatment for Post Traumatic Stress Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02945709
Enrollment
60
Registered
2016-10-26
Start date
2016-10-31
Completion date
2019-12-31
Last updated
2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD

Keywords

PTSD, attention training, cognitive bias modification

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.

Interventions

BEHAVIORALPersonalized Attention control training (ACT)

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.

BEHAVIORALNon-personalized Attention control training (ACT)

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.

BEHAVIORALControl training.

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.

Sponsors

Tel Aviv University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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. -

Design outcomes

Primary

MeasureTime frameDescription
A diagnosis of PTSD and a total score of severity symptoms, as driven from the CAPS-5 interview40 minutesThe 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

MeasureTime frameDescription
Total score of the PTSD Checklist (PCL-5).10 minutesThe 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).

Other

MeasureTime frameDescription
Total score of the PHQ-910 minutesThe PHQ-9 , us a 10-item scale for depression symptoms.
The CGI/S5 minutesSeverity 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).

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026