NCT03950869

Brief Summary

In the experimental study, the well-established trauma film paradigm will be used to investigate the impact of expectations on the development of intrusive memories as a hallmark symptom of PTSD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

May 31, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

May 13, 2019

Last Update Submit

September 7, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frequency and severity of intrusive memories: Daily intrusion diary

    Participants are asked to complete a pen-and-paper diary 7 days in a row, reporting on intrusive memories in reference to the trauma film. They are asked to state the number of intrusions per day; each day of the diary is labeled and split into three sections (morning, afternoon, evening), and they are asked to mark in a box in the appropriate section when they experienced an intrusion. For each intrusion, they indicate the quality of the intrusion (image, thought or both), the intensity of and distress caused by the intrusion both on a scale ranging from 0 ("not at all") to 10 ("extremely"), the content of the intrusion, and the situation in which the intrusion occurred. Intrusive memory frequency across 7 days are calculated, whilst higher sum scores represent more intrusions. Severity of intrusions are calculated by combining the average score of the intensity and distress scale across all intrusions, whilst higher values indicate higher intensity/distress of reported intrusions.

    Record of any intrusive memories of the trauma film content for Days 1 to 7 after the experimental manipulation.

Secondary Outcomes (2)

  • Distress caused by the trauma film: Impact of Event Scale-Revised (IES-R)

    At the follow-up measurement (7 days after the experimental manipulation).

  • Laboratory assessment of intrusive memories: Intrusion Provocation Task (IPT)

    At the follow-up measurement (7 days after the experimental manipulation).

Other Outcomes (2)

  • Appraisals of Intrusions Questionnaire

    At baseline and the follow-up measurement (7 days after the experimental manipulation).

  • Retrospective Assessment of Active Processing

    At the follow-up measurement (7 days after the experimental manipulation) retrospectively on Days 1 to 7 after the experimental manipulation.

Study Arms (3)

Negative Expectations

EXPERIMENTAL

Expectations on the severity and frequency of intrusions are increased while expectations on the controllability of intrusions are decreased.

Behavioral: Negative Expectation Manipulation

Positive Expectations

EXPERIMENTAL

Expectations on the severity and frequency of intrusions are decreased while expectations on the controllability of intrusions are increased.

Behavioral: Positive Expectation Manipulation

No Expectation Manipulation

NO INTERVENTION

Expectations on the severity and frequency of intrusions and on the controllability are neither increased nor decreased.

Interventions

Participants are watching a video tape of a trauma expert who provides selective information on the development of intrusive memories. This video tape aims to increase positive expectations.

Positive Expectations

Participants are watching a video tape of a trauma expert who provides selective information on the development of intrusive memories. This video tape aims to increase negative expectations.

Negative Expectations

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers
  • fluent in German language

You may not qualify if:

  • history of traumatic experiences (LEC-5)
  • presence of a mental disorder (SCID-I according to DSM-IV)
  • cut-off in depression screening (PHQ-9)
  • current suicidal thoughts/behavior or non-suicidal self-injury behavior (C-SSRS)
  • medical history of heart disease or epilepsy
  • history of fainting
  • work experience in the medical field (e.g., nurses, paramedics, etc.)
  • visual impairment
  • students of psychology and medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Clinical Psychology and Psychological Interventions, Department of Psychology, Philipps University Marburg

Marburg, Hesse, 35032, Germany

Location

Related Publications (3)

  • Holmes EA, Bourne C. Inducing and modulating intrusive emotional memories: a review of the trauma film paradigm. Acta Psychol (Amst). 2008 Mar;127(3):553-66. doi: 10.1016/j.actpsy.2007.11.002. Epub 2008 Jan 29.

    PMID: 18234153BACKGROUND
  • James EL, Lau-Zhu A, Clark IA, Visser RM, Hagenaars MA, Holmes EA. The trauma film paradigm as an experimental psychopathology model of psychological trauma: intrusive memories and beyond. Clin Psychol Rev. 2016 Jul;47:106-42. doi: 10.1016/j.cpr.2016.04.010. Epub 2016 Apr 21.

    PMID: 27289421BACKGROUND
  • Iyadurai L, Visser RM, Lau-Zhu A, Porcheret K, Horsch A, Holmes EA, James EL. Intrusive memories of trauma: A target for research bridging cognitive science and its clinical application. Clin Psychol Rev. 2019 Apr;69:67-82. doi: 10.1016/j.cpr.2018.08.005. Epub 2018 Aug 23.

    PMID: 30293686BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Eva-Lotta Brakemeier, Professor

    Philipps University Marburg

    PRINCIPAL INVESTIGATOR
  • Winfried Rief, Professor

    Philipps University Marburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants are assigned to one of three arms in parallel for the duration of the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 15, 2019

Study Start

May 31, 2019

Primary Completion

September 30, 2019

Study Completion

December 31, 2019

Last Updated

September 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

No IPD will be shared.

Locations