The Role of Expectations in the Development of Intrusive Memories

September 7, 2021 updated by: Philipps University Marburg Medical Center

The Role of Expectations in the Development of Intrusive Memories: An Experimental Approach Using the Trauma Film Paradigm

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Marburg, Hessen, Germany, 35032
        • Division of Clinical Psychology and Psychological Interventions, Department of Psychology, Philipps University Marburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Negative Expectations
Expectations on the severity and frequency of intrusions are increased while expectations on the controllability of intrusions are decreased.
Behavioral: Negative Expectation Manipulation
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.
Experimental: Positive Expectations
Expectations on the severity and frequency of intrusions are decreased while expectations on the controllability of intrusions are increased.
Behavioral: Positive Expectation Manipulation
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.
No Intervention: No Expectation Manipulation
Expectations on the severity and frequency of intrusions and on the controllability are neither increased nor decreased.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency and severity of intrusive memories: Daily intrusion diary
Time Frame: Record of any intrusive memories of the trauma film content for Days 1 to 7 after the experimental manipulation.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Distress caused by the trauma film: Impact of Event Scale-Revised (IES-R)
Time Frame: At the follow-up measurement (7 days after the experimental manipulation).
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.
At the follow-up measurement (7 days after the experimental manipulation).
Laboratory assessment of intrusive memories: Intrusion Provocation Task (IPT)
Time Frame: At the follow-up measurement (7 days after the experimental manipulation).
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.
At the follow-up measurement (7 days after the experimental manipulation).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Appraisals of Intrusions Questionnaire
Time Frame: At baseline and the follow-up measurement (7 days after the experimental manipulation).
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.
At baseline and the follow-up measurement (7 days after the experimental manipulation).
Retrospective Assessment of Active Processing
Time Frame: At the follow-up measurement (7 days after the experimental manipulation) retrospectively on Days 1 to 7 after the experimental manipulation.
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.
At the follow-up measurement (7 days after the experimental manipulation) retrospectively on Days 1 to 7 after the experimental manipulation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philipps University Marburg Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Winfried Rief, Professor, Philipps University Marburg Medical Center
  • Principal Investigator: Eva-Lotta Brakemeier, Professor, Philipps University Marburg Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No IPD will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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