Clinical trial NCT02945709: Attention Control Treatment for Post Traumatic Stress Disorder ׂ(PTSD)
Official title: Attention Control Treatment for Post Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: PTSD
attention training
cognitive bias modification
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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. -

Primary outcomes:
measure: A diagnosis of PTSD and a total score of severity symptoms, as driven from the CAPS-5 interview
timeFrame: 40 minutes
Secondary outcomes:
measure: Total score of the PTSD Checklist (PCL-5).
timeFrame: 10 minutes
Other outcomes:
measure: Total score of the PHQ-9
timeFrame: 10 minutes
measure: The CGI/S
timeFrame: 5 minutes
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
affiliation: Tel Aviv University
name: Yair Bar-Haim, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-5). American Psychiatric Pub, 2013
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.
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.