Back to resultsThe Role of Expectations in the Development of Intrusive Memories
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Positive Expectation Manipulation
Negative Expectation Manipulation
Sponsored by
About this trial
This is an interventional basic science trial for Posttraumatic Stress Disorder
Eligibility Criteria
Inclusion Criteria:
- healthy volunteers
- fluent in German language
Exclusion Criteria:
- 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
Sites / Locations
- Division of Clinical Psychology and Psychological Interventions, Department of Psychology, Philipps University Marburg
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Negative Expectations
Positive Expectations
No Expectation Manipulation
Arm Description
Expectations on the severity and frequency of intrusions are increased while expectations on the controllability of intrusions are decreased.
Expectations on the severity and frequency of intrusions are decreased while expectations on the controllability of intrusions are increased.
Expectations on the severity and frequency of intrusions and on the controllability are neither increased nor decreased.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Distress caused by the trauma film: Impact of Event Scale-Revised (IES-R)
Participants are asked to respond 22 items in reference to the trauma film (e.g., "Pictures about the film popped into my mind.") by indicating how often each reaction occurred during the past seven days with respect to the film they watched last week. Items are rated on a 4-point-Likert-scale ranging from 0 ("not at all"), 1 ("rare"), 3 ("sometimes") to 5 ("often"). The IES-R consists of three subscales: "intrusion", "hyperarousal", and "avoidance". The total score (sum score for the total scale comprising the sum scores of all three subscales) is calculated ranging from 0 to 110 with higher values represent a worse outcome, i.e., higher total distress due to the trauma film in the past week. In addition, the sum score for the intrusion subscale is separately calculated ranging from 0 to 35 (Items 1, 3, 6, 9, 14, 16, 20) with higher values represent more intrusions due to the trauma film in the past week.
Laboratory assessment of intrusive memories: Intrusion Provocation Task (IPT)
In the Intrusion Provocation Task (IPT), participants are presented with a ten-second long neutral still image from each of the film clips. Immediately afterwards for the next two minutes, they are allowed to think freely and report intrusions by raising a finger. The investigator counts how often the participant lifts his finger in the two minutes. The IPT intrusion score is calculated by the total frequency of intrusions, whilst higher values represent more intrusions.
Full Information
NCT ID
NCT03950869
First Posted
May 13, 2019
Last Updated
September 7, 2021
Sponsor
Philipps University Marburg Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03950869
Brief Title
The Role of Expectations in the Development of Intrusive Memories
Official Title
The Role of Expectations in the Development of Intrusive Memories: An Experimental Approach Using the Trauma Film Paradigm
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philipps University Marburg Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The study aims to examine the influence of different expectations on the development of intrusive memories by using a well-established experimental paradigm - the trauma film paradigm. In healthy volunteers, intrusion-like symptoms are to be induced with an analogue stressor, i.e., aversive film clip footage (trauma film). After viewing this so-called trauma film, the expectations of intrusions during the following week are manipulated by assigning participants randomly to three different groups. In the first group, negative expectations are induced (experimental group 1), the second group is exposed to positive expectations (experimental group 2) and a third group does not face any kind of manipulation of their expectations (control group). Participants are asked to report occurring intrusions in a diary during the following week and are invited to a subsequent cued laboratory inquiry at follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of three arms in parallel for the duration of the study.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Negative Expectations
Arm Type
Experimental
Arm Description
Expectations on the severity and frequency of intrusions are increased while expectations on the controllability of intrusions are decreased.
Arm Title
Positive Expectations
Arm Type
Experimental
Arm Description
Expectations on the severity and frequency of intrusions are decreased while expectations on the controllability of intrusions are increased.
Arm Title
No Expectation Manipulation
Arm Type
No Intervention
Arm Description
Expectations on the severity and frequency of intrusions and on the controllability are neither increased nor decreased.
Intervention Type
Behavioral
Intervention Name(s)
Positive Expectation Manipulation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Negative Expectation Manipulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency and severity of intrusive memories: Daily intrusion diary
Description
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.
Time Frame
Record of any intrusive memories of the trauma film content for Days 1 to 7 after the experimental manipulation.
Secondary Outcome Measure Information:
Title
Distress caused by the trauma film: Impact of Event Scale-Revised (IES-R)
Description
Participants are asked to respond 22 items in reference to the trauma film (e.g., "Pictures about the film popped into my mind.") by indicating how often each reaction occurred during the past seven days with respect to the film they watched last week. Items are rated on a 4-point-Likert-scale ranging from 0 ("not at all"), 1 ("rare"), 3 ("sometimes") to 5 ("often"). The IES-R consists of three subscales: "intrusion", "hyperarousal", and "avoidance". The total score (sum score for the total scale comprising the sum scores of all three subscales) is calculated ranging from 0 to 110 with higher values represent a worse outcome, i.e., higher total distress due to the trauma film in the past week. In addition, the sum score for the intrusion subscale is separately calculated ranging from 0 to 35 (Items 1, 3, 6, 9, 14, 16, 20) with higher values represent more intrusions due to the trauma film in the past week.
Time Frame
At the follow-up measurement (7 days after the experimental manipulation).
Title
Laboratory assessment of intrusive memories: Intrusion Provocation Task (IPT)
Description
In the Intrusion Provocation Task (IPT), participants are presented with a ten-second long neutral still image from each of the film clips. Immediately afterwards for the next two minutes, they are allowed to think freely and report intrusions by raising a finger. The investigator counts how often the participant lifts his finger in the two minutes. The IPT intrusion score is calculated by the total frequency of intrusions, whilst higher values represent more intrusions.
Time Frame
At the follow-up measurement (7 days after the experimental manipulation).
Other Pre-specified Outcome Measures:
Title
Appraisals of Intrusions Questionnaire
Description
The Appraisals of Intrusions Questionnaire is 25-item measure that assesses metacognitions of intrusive thoughts and memories. Participants rated the strength of each belief when they experienced their intrusive memories on a scale ranging from 0 (I didn't believe that at all.) to 100 (I was completely convinced that this was true.). Metacognitive appraisals are divided into four categories: "necessity of control", "external consequences", "psychological problem" and "negative self-evaluation". A total score is calculated, whilst higher values indicate more dysfunctional metacognitive beliefs.
Time Frame
At baseline and the follow-up measurement (7 days after the experimental manipulation).
Title
Retrospective Assessment of Active Processing
Description
Participants are asked in a self-report questionnaire to report for each day and each film clip the amount of time they spent actively processing the content of the film or intrusions associated to it, e.g., by intentionally thinking about it or by discussing it with other people. The participants are asked to rate how many minutes each day they have consciously dealt with the specific film clips or the memories of them. The scale ranges from 0 to 100 minutes in order to pre-define a lower and upper bound. The total score is calculated, whilst higher values indicate a better outcome.
Time Frame
At the follow-up measurement (7 days after the experimental manipulation) retrospectively on Days 1 to 7 after the experimental manipulation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy volunteers
fluent in German language
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva-Lotta Brakemeier, Professor
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Winfried Rief, Professor
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Clinical Psychology and Psychological Interventions, Department of Psychology, Philipps University Marburg
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35032
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared.
Citations:
PubMed Identifier
18234153
Citation
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.
Results Reference
background
PubMed Identifier
27289421
Citation
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.
Results Reference
background
PubMed Identifier
30293686
Citation
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.
Results Reference
background
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The Role of Expectations in the Development of Intrusive Memories
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