Clinical trial NCT04228133: Home-Delivered Attention Control Treatment for Post Traumatic Stress Disorder (PTSD)
Official title: Home-Delivered Attention Control Training for Post Traumatic Stress Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: PTSD
attention training
cognitive bias modification
home-delivered intervention
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change from baseline of the total severity score of the CAPS-5 interview
timeFrame: up to 2 weeks pre-treatment and 1-2 weeks post-treatment
Secondary outcomes:
measure: Change from baseline of the total score of the PTSD Checklist (PCL-5)
timeFrame: up to 2 weeks pre-treatment and 1-2 weeks post-treatment
Other outcomes:
measure: Change from baseline of the total score of the PHQ-9
timeFrame: up to 2 weeks pre-treatment and 1-2 weeks post-treatment
measure: The Credibility/Expectancy Questionnaire (CEQ)
timeFrame: up to 2 weeks pre-treatment and 1-2 weeks post-treatment
measure: The CGI/S
timeFrame: up to 2 weeks pre-treatment and 1-2 weeks post-treatment
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
affiliation: Tel Aviv University
name: Yair Bar-Haim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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citation: Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
citation: Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess. 2018 Mar;30(3):383-395. doi: 10.1037/pas0000486. Epub 2017 May 11.