An interventional study of Positive Expectation Manipulation and Negative Expectation Manipulation in Posttraumatic Stress Disorder, sponsored by Philipps University Marburg. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-08.
Sponsored by Philipps University Marburg · Not applicable, Interventional, and Basic science
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.
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.
2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.
This study's enrollment of 90 is above the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Philipps University Marburg is the lead sponsor of 114 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Expectations on the severity and frequency of intrusions are increased while expectations on the controllability of intrusions are decreased.
Behavioral: Negative Expectation Manipulation
Expectations on the severity and frequency of intrusions are decreased while expectations on the controllability of intrusions are increased.
Behavioral: Positive Expectation Manipulation
Expectations on the severity and frequency of intrusions and on the controllability are neither increased nor decreased.
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.
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.
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.
Time frame: Record of any intrusive memories of the trauma film content for Days 1 to 7 after the experimental manipulation.
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.
Time frame: At the follow-up measurement (7 days after the experimental manipulation).
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.
Time frame: At the follow-up measurement (7 days after the experimental manipulation).
Appraisals of Intrusions Questionnaire
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).
Retrospective Assessment of Active Processing
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.
Plan to share: No — No IPD will be shared.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic→
Philipps University Marburg