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Completed

NCT Number: NCT04228133

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

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.

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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 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.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Attention control training (ACT)

Behavioral

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.

Attention Bias Modification (ABM)

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 14, 2020
Registry last updated
Apr 6, 2021

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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