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

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04228133
• Other study ID #: TAU-ACT
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: April 5, 2021

Study information

• Verified date: April 2021
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 5, 2021
• Est. primary completion date: April 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

References & Publications (9)

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. — View 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. — View Citation

Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. — View Citation

Hedges DW, Brown BL, Shwalb DA. A direct comparison of effect sizes from the clinical global impression-improvement scale to effect sizes from other rating scales in controlled trials of adult social anxiety disorder. Hum Psychopharmacol. 2009 Jan;24(1):35-40. doi: 10.1002/hup.989. — View Citation

Kadouri A, Corruble E, Falissard B. The improved Clinical Global Impression Scale (iCGI): development and validation in depression. BMC Psychiatry. 2007 Feb 6;7:7. — View 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. — View Citation

Lazarov A, Suarez-Jimenez B, Abend R, Naim R, Shvil E, Helpman L, Zhu X, Papini S, Duroski A, Rom R, Schneier FR, Pine DS, Bar-Haim Y, Neria Y. Bias-contingent attention bias modification and attention control training in treatment of PTSD: a randomized control trial. Psychol Med. 2019 Oct;49(14):2432-2440. doi: 10.1017/S0033291718003367. Epub 2018 Nov 12. — View Citation

Linetzky M, Pergamin-Hight L, Pine DS, Bar-Haim Y. Quantitative evaluation of the clinical efficacy of attention bias modification treatment for anxiety disorders. Depress Anxiety. 2015 Jun;32(6):383-91. doi: 10.1002/da.22344. Epub 2015 Feb 24. Erratum in: Depress Anxiety. 2018 Jan;35(1):111-112. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline of the total score of the PHQ-9	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
Other	The Credibility/Expectancy Questionnaire (CEQ)	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
Other	The CGI/S	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
Primary	Change from baseline of the total severity score of the CAPS-5 interview	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	Change from baseline of the total score of the PTSD Checklist (PCL-5)	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