Posttraumatic Stress DisorderNCT03950869
The Role of Expectations in the Development of Intrusive Memories
A study testing Positive Expectation Manipulation and Negative Expectation Manipulation in people with Posttraumatic Stress Disorder, run by Philipps University Marburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Positive Expectation Manipulation and Negative Expectation Manipulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 31 May 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
- fluent in German language
Who cannot join
- 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
Show all 9Show fewer
- work experience in the medical field (e.g., nurses, paramedics, etc.)
- visual impairment
- students of psychology and medicine
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Clinical Psychology and Psychological Interventions, Department of Psychology, Philipps University Marburg
Marburg, Hesse, 35032
About this study
Official title: 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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Positive Expectation Manipulation, Negative Expectation Manipulation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Expectation ManipulationBehavioural
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.
Negative Expectation ManipulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Negative Expectations | Experimental | Expectations on the severity and frequency of intrusions are increased while expectations on the controllability of intrusions are decreased. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: At the follow-up measurement (7 days after the experimental manipulation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start31 May 2019
- Primary completion30 Sep 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of three arms in parallel for the duration of the study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva-Lotta Brakemeier, Professor, Principal investigator, Philipps University MarburgWinfried Rief, Professor, Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950869
- Sponsor's protocol ID
- 2019-07
- Status last verified
- Sep 2021
- First submitted
- 13 May 2019
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared.
Publications
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.
PubMed 18234153James 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.
PubMed 27289421Iyadurai 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.
PubMed 30293686
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Expectations in the Development of Intrusive Memories: An Experimental Approach Using the Trauma Film Paradigm
- ClinicalTrials.gov ID
- NCT03950869
- Acronym / sponsor ID
- 2019-07
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are assigned to one of three arms in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Negative Expectations | Experimental | Behavioral: Negative Expectation ManipulationExpectations on the severity and frequency of intrusions are increased while expectations on the controllability of intrusions are decreased. |
| Positive Expectations | Experimental | Behavioral: Positive Expectation ManipulationExpectations on the severity and frequency of intrusions are decreased while expectations on the controllability of intrusions are increased. |
| No Expectation Manipulation | No intervention | –Expectations on the severity and frequency of intrusions and on the controllability are neither increased nor decreased. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy volunteers
- fluent in German language
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Expectation ManipulationParticipants 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. | Behavioural | Positive Expectations |
| Negative Expectation ManipulationParticipants 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. | Behavioural | Negative Expectations |
Primary outcome
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.
2 secondary outcomes
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).
Laboratory assessment of intrusive memories: Intrusion Provocation Task (IPT)
Time frame: At the follow-up measurement (7 days after the experimental manipulation).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Background: PubMed 18234153Holmes 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.
- Background: PubMed 27289421James 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.
- Background: PubMed 30293686Iyadurai 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.
- Individual participant dataSharing planned: No. No IPD will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva-Lotta Brakemeier, Professor principal investigator
Philipps University Marburg
Winfried Rief, Professor principal investigator
Philipps University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Expectation Manipulation and Negative Expectation Manipulation in people with Posttraumatic Stress Disorder, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03950869, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.