Home-Delivered Attention Control Treatment for Post Traumatic Stress Disorder (PTSD)

April 5, 2021 updated by: Yair Bar-Haim, Tel Aviv University

Home-Delivered Attention Control Training for Post Traumatic Stress Disorder: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 6997801
        • Tel Aviv University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Home-delivered attention control training (ACT)
A home-delivered ACT comprised of 8 sessions with a variation of the dot-probe task in which the target probe replaces the neutral and threat stimuli with an equal probability to reduce attention bias variability (ABV).
Behavioral: Attention Control Training (ACT)
A home-delivered version of ACT will be administered in this study. ACT will be comprised of 8 sessions with a variation of the dot-probe task in which the target probe replaces the neutral and threat stimuli with an equal probability to reduce attention bias variability (ABV). In addition, sessions will include video conference with the experimenter. This condition has found to be more effective in PTSD symptom reduction compared to ABM.
PLACEBO_COMPARATOR: Home-delivered attention bias modification (ABM)
A home-delivered ABM comprised of 8 sessions with a variation of the dot-probe task in which the target probe always replaces the threat stimuli to induce diversion of attention away from threat.
Behavioral: Attention Bias Modification (ABM)
A home-delivered version of ABM will be administered in this study. ABM will be comprised of 8 sessions with a variation of the dot-probe task in which the target probe always replaces the threat stimuli to induce diversion of attention away from threat. In addition, sessions will include video conference with the experimenter. This condition has found to be have an inferior effect on PTSD symptom reduction compared to ACT, and thus, this ABM condition has been chosen as a control condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of the total severity score of the CAPS-5 interview
Time Frame: up to 2 weeks pre-treatment and 1-2 weeks post-treatment
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, with higher scores denoting higher symptom severity.
up to 2 weeks pre-treatment and 1-2 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of the total score of the PTSD Checklist (PCL-5)
Time Frame: up to 2 weeks pre-treatment and 1-2 weeks post-treatment
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.
up to 2 weeks pre-treatment and 1-2 weeks post-treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of the total score of the PHQ-9
Time Frame: up to 2 weeks pre-treatment and 1-2 weeks post-treatment
The PHQ-9 is a 9-item scale for depression symptoms (Kroenke, Spitzer, & Williams, 2001). Scores can range from 0 to 27, with higher scores reflecting more symptoms of depression.
up to 2 weeks pre-treatment and 1-2 weeks post-treatment
The Credibility/Expectancy Questionnaire (CEQ)
Time Frame: up to 2 weeks pre-treatment and 1-2 weeks post-treatment
The Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000). This instrument consists of 6 items which derive two factors: expectancy for change and treatment credibility. This CEQ will be used to explore whether expectancies or treatment credibility are related to outcomes. It demonstrated high internal consistency and good test-retest reliability.
up to 2 weeks pre-treatment and 1-2 weeks post-treatment
The CGI/S
Time Frame: up to 2 weeks pre-treatment and 1-2 weeks post-treatment
Severity and improvement scales (CGI-S/I) 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.
up to 2 weeks pre-treatment and 1-2 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel Aviv University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ACTUAL)

April 5, 2021

Study Completion (ACTUAL)

April 5, 2021

Study Registration Dates

First Submitted

January 1, 2020

First Submitted That Met QC Criteria

January 12, 2020

First Posted (ACTUAL)

January 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAU-ACT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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