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Completed

NCT Number: NCT05242263

ACT With Feedback for Post Traumatic Stress Disorder (PTSD)

The purpose of this study is to explore the efficacy of Attention Control Training with the inclusion of feedback for Post Traumatic Stress Disorder (PTSD).

It seems that the most efficient ABMT method to balance attention bias variability (ABV) among individuals with PTSD is Attention Control Training (ACT). This type of training is designed to balance attention allocation towards threat-related and neutral stimuli. A few studies have further shown that this training type succeeds in balancing the aberrant fluctuations in attention bias observed in patients with PTSD, and that this leads to a reduction in PTSD symptoms (Badura-Brack et al., 2015).

The purpose of the current study is to examine the efficacy of ACT that also includes feedback. Specifically, we intend to test whether the inclusion of feedback on top of standard ACT may enhance training efficacy in reducing ABV and in reducing PTSD symptoms.

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel Aviv University

Tel Aviv, 6997801, Israel

About this study

The aim of the current study is to explore the efficacy of Attention Control Training with the inclusion of feedback for Post Traumatic Stress Disorder (PTSD).

Individuals with PTSD exhibit increased threat-related attention bias variability (ABV; Lacoviello et al., 2014; Naim et al., 2015). Based on these findings, computerized training methods aimed to modify the attention bias were developed (Attention Bias Modification Training; ABMT).

It seems that the most efficient ABMT method to balance ABV among individuals with PTSD is Attention Control Training (ACT). This type of training is designed to balance attention allocation towards threat-related and neutral stimuli. A few studies have further shown that this training type succeeds in balancing the aberrant fluctuations in attention bias observed in PTSD, and that this leads to a reduction in PTSD symptoms (Badura-Brack et al., 2015).

The purpose of the current study is to examine the efficacy of ACT that also includes a feedback component. Specifically, we intend to test whether the inclusion of feedback on top of standard ACT may enhance training efficacy in reducing ABV and in reducing PTSD symptoms.

For this purpose, we will recruit 60 IDF veterans diagnosed with PTSD that will be randomly assigned to one of two conditions: ACT with feedback or ACT with yoked sham feedback.

We expect that ACT with feedback will produce greater reduction in PTSD symptoms and in ABV relative to ACT with yoked sham feedback.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of PTSD according to the DSM-5 and related to military service, ages 18-65

Exclusion criteria

  • Psychotic or Bipolar disorder, drug and alcohol abuse, other psychological treatment, vision problems that are not overcome with regular glasses, physical disability that prevents ability to operate computer.

Treatment and study plan

Attention Control Training (ACT) with ABV feedback

Behavioral

At the beginning of each session, participants will complete 45 standard dot-probe trials as described above. Participants' ABV on these trials will be calculated and set as their personal baseline (see below for ABV calculation). In the following 165-training trials, participants will receive feedback: when their online-calculated ABV will be below their baseline screen background will be green whereas its color will be red when their online ABV score will be higher than their baseline. Patients will be instructed to try to keep the background green for as long as possible.

Attention Control Training (ACT) with yoked sham feedback

Behavioral

Participants in this group will be exposed to the same task as in the active group but will receive sham feedback that is unrelated to their ABV during task performance. They will be presented with a feedback that is yoked to the one given to a participant in the training group.

Primary outcomes

  1. Change from baseline of the total severity score of the CAPS-5 interview

    Time frame: Measurements at Baseline, 1 week post treatment, and 3-months follow-up 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.

Secondary outcomes

  1. Change from baseline of the total score of the PTSD Checklist (PCL-5)

    Time frame: Measurements at Baseline, 1 week post treatment, and 3-months follow-up 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.

  2. Change from baseline of the total score of the PHQ-9

    Time frame: Measurements at Baseline, 1 week post treatment, and 3-months follow-up 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.

Other outcomes

  1. Post-Training Attention Bias Variability

    Time frame: Measurements at Baseline, 1 week post treatment, and 3-months follow-up post treatment

    Change in Attention Bias Variability from Baseline to Post-training measurement and follow-up. ABV is calculated in four steps: 1) a trial-by trial moving average algorithm computed reaction times for all successive 10 neutral trial blocks and all successive 10 threat trial blocks, 2) successive attention bias scores were calculated by subtracting the first threat block average from the first neutral block average, the second threat block average from the second neutral block average, etc., forming a series of consecutive attention bias scores, 3) the standard deviation of these successive bias scores was then calculated, providing an index of variation in attention bias throughout the session, and 4) this standard deviation score was divided by the participant's mean overall reaction time

  2. The Credibility/Expectancy Questionnaire (CEQ)

    Time frame: Measurements at Baseline, 1 week post treatment, and 3-months follow-up 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.

  3. The CGI-I

    Time frame: 1 week post treatment, and 3-months follow-up post treatment

    Severity and improvement scale (CGI-I) will be used to assess participants global clinical condition. The CGI-I is single-item, clinician-reported, measure assessing severity and improvement of illness using a 7-point Likert-type scale.

  4. The CGI-S

    Time frame: 1 week post treatment, and 3-months follow-up post treatment

    Severity and improvement scales (CGI-S ) will be used to assess participants global clinical condition. The CGI-S is single-item, clinician-reported, measure assessing severity and improvement of illness using a 7-point Likert-type scale.

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Registry information

Official study title

Reducing Attention Bias Variability Using Attention Control Training With Feedback Among Individuals With Posttraumatic Stress Disorder

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 16, 2022
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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