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

NCT04228133 | Completed

• 1 other identifier: TAU-ACT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD

Keywords

PTSD; attention training; cognitive bias modification; home-delivered intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  up to 2 weeks pre-treatment and 1-2 weeks post-treatment

Other Outcomes (3)

• Change from baseline of the total score of the PHQ-9

  up to 2 weeks pre-treatment and 1-2 weeks post-treatment

• The Credibility/Expectancy Questionnaire (CEQ)

  up to 2 weeks pre-treatment and 1-2 weeks post-treatment

• The CGI/S

  up to 2 weeks pre-treatment and 1-2 weeks post-treatment

Study Arms (2)

Home-delivered attention control training (ACT)

EXPERIMENTAL

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)

Home-delivered attention bias modification (ABM)

PLACEBO COMPARATOR

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)

Interventions

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.

Home-delivered attention control training (ACT)

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.

Home-delivered attention bias modification (ABM)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Tel Aviv University

Tel Aviv, 6997801, Israel

Location

Related 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.

  PMID: 26206075 BACKGROUND

• 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.

  PMID: 30415648 BACKGROUND

• 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.

  PMID: 25708991 BACKGROUND

• 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.

  PMID: 18980264 BACKGROUND

• 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. doi: 10.1186/1471-244X-7-7.

  PMID: 17284321 BACKGROUND

• 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.

  PMID: 11132119 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 26606250 BACKGROUND

• 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.

  PMID: 28493729 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Yair Bar-Haim, PhD

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology and Neuroscience School of Psychological Sciences Sagol School of Neuroscience Tel Aviv University

Study Record Dates

• First Submitted: January 1, 2020
• First Posted: January 14, 2020
• Study Start: January 1, 2020
• Primary Completion: April 5, 2021
• Study Completion: April 5, 2021
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)