Can a simple task help reduce intrusive memories in patients suffering from intrusions after traumatic events?
| ISRCTN | ISRCTN52555566 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52555566 |
- Submission date
- 27/10/2021
- Registration date
- 29/10/2021
- Last edited
- 17/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Some people who have experienced traumatic events (e.g. violence, accidents, or critical illness) suffer from intrusive memories. These are memories - often in the form of mental images, or films - that occur involuntarily and can cause severe distress. Intrusive memories form a core symptom of Posttraumatic Stress Disorder (PTSD), a mental condition that causes severe suffering in patients and poses a considerable social and economic burden. While a number of effective treatments for PTSD have been established, many of them require highly-trained specialists and are therefore (or for other reasons) limited in their availability. This study investigates the effect of a novel approach to reduce intrusive memories, using a simple visuospatial task after reactivation of a traumatic memory. The task is part of a commonly used test for prospective physicians (so called Test für Medizinische Studiengänge -TMS) and examines skills in spatial imagination. The effect of this intervention is compared to another intervention, in which participants will read a text and answer questions relating to the text afterwards. We hypothesize that the visuospatial intervention leads to a greater reduction of intrusions than the control condition.
Who can participate?
Adults (at least 18 years of age) who have experienced at least one traumatic event and are currently suffering from intrusive memories. Participants must have sufficient knowledge of the German language to read and understand longer texts (~25min).
What does the study involve?
Participants will have 3 study appointments over the course of 4 weeks. Throughout, they will keep an electronic "intrusion diary", in which they will record the occurrence of specific intrusive memories, which have been decided upon on the first appointment. 2 weeks after the first appointment, they will receive one of two interventions: They will either be asked to write down one of the intrusive memories and deal with a repetitive simple visuospatial task. In this task 80 items will be provided. The challenge is to rotate two cubes mentally. Those two cubes are identical but shown from different perspectives. The participants‘ job is to find out how to rotate the first cube to make it look like the second one. In the other condition, they will read an article from Wikipedia, and answer some multiple-choice questions relating to the article afterwards. 2 weeks after the intervention, participants will be invited to answer some questions about the study and are asked for permission to be contacted 6 months after the end of the study for a telephone follow-up.
What are the possible benefits and risks of participating?
In case the intervention proves effective, participants would directly benefit from the reduction of intrusive memories. We expect no negative effects from the questionnaires, the visuospatial task, or reading the Wikipedia Article. Writing down the traumatic memory could possibly lead to arousal and distress. To ensure maximum safety, study sessions take place in the secure and well-monitored environment of a university hospital, and professional support from psychotherapeutically trained physicians is always available. During the study sessions, a member of the research team is always present in the room.
Where is the study run from?
LWL University Hospital Bochum (Germany), Department of Psychosomatic Medicine and Psychotherapy.
When is the study starting and how long is it expected to run for?
January 2021 to June 2023
Who is funding the study?
Application for funding from the Ruhr-University Bochum (FoRUM) is planned.
Who is the main contact?
Professor Henrik Kessler
henrik.kessler@ruhr-uni-bochum.de
Contact information
Scientific
Klinik für Psychosomatische Medizin und Psychotherapie
LWL-Universitätsklinikum Bochum
Alexandrinenstr. 1-3
Bochum
44791
Germany
| Phone | +49-234-5077-3176 |
|---|---|
| henrik.kessler@rub.de |
Study information
| Study design | Single-center interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Investigation on a novel approach for reducing intrusions in patients after a traumatic event. A randomized, controlled interventional trial using a memory reminder and a visuospatial task. |
| Study objectives | Reactivation of a trauma-related memory, followed by executing a visuospatial task (a commonly used task to test skills in spatial imagination) will significantly reduce the frequency of visual intrusions of the traumatic event in the weeks following the intervention, compared to a verbal control task. |
| Ethics approval(s) | Approved 07/10/2021, Ethikkommission der Fakultät für Medizin an der Ruhr-Universität Bochum (Ethics committee at the department of Medicine, Ruhr-University Bochum, Gesundheitscampus 33, Bochum, Germany; +49 (0)234 7981 6555; ethik@ruhr-uni-bochum.de), ref: 21-7268 |
| Health condition(s) or problem(s) studied | Patients suffering from intrusive memories after traumatic experiences |
| Intervention | Patients receive randomized either the experimental intervention (1.) or the control intervention (2.) at T1 (T0 + 2 weeks): 1. Reactivation of a trauma-related memory by writing down the memory of a specific traumatic event, followed by 25 min of executing a visuospatial task 2. Reading a Wikipedia article for 25 min and answering 8 multiple choice questions relating to the article afterwards Participants will be followed up for 4 weeks (2 weeks preinterventional and 2 weeks postinterventional). Randomisation is implemented electronically via the software package REDCap at the AMIB (Ruhr-Universität Bochum, Abteilung für Medizinische Informatik, Biometrie und Epidemiologie, Nina Timmesfeld) and hence occurs independently from the researchers who are in direct contact with the patients. After typing in the patient number at T1, the researcher electronically receives the intervention to be applied in this session. To compute the randomization scheme, interventions are randomly permutated and assigned to T1. |
| Intervention type | Behavioural |
| Primary outcome measure | Frequency of intrusions per week , assessed by patients via an intrusion diary continuously for each week of the 4-week study duration; main focus is on the specific effect on the frequency of intrusions in the two weeks following the intervention. Additonally, retrospectively estimated frequency of intrusions will be assessed in a 6-month telephone follow-up. |
| Secondary outcome measures | Severity of PTSD-related symptoms, assessed via PTSD Checklist for DSM-5 (PCL-5) at T0 and T2. |
| Overall study start date | 01/01/2021 |
| Completion date | 13/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 per protocol |
| Total final enrolment | 52 |
| Key inclusion criteria | Current inclusion criteria as of 11/03/2022: 1. Age 18+ years 2. Have experienced at least 1 traumatic event (fulfilling criterion A for PTSD diagnosis according to DSM-5) which happened at least 2 months ago 3. Suffer from intrusive memories that relate to the traumatic event named in 2. Those intrusions should have occurred at least five times a week for the past 2 weeks 4. Sufficient knowledge of the German language (These were changed before the first participant was recruited.) _____ Previous inclusion criteria: 1. Age 18+ years 2. Have experienced at least 1 traumatic event (fulfilling criterion A for PTSD diagnosis according to DSM-5) 3. Suffer from intrusive memories that relate to the traumatic event named in 2. Those intrusions should have occurred at least five times a week for the past 2 weeks 4. Sufficient knowledge of the German language |
| Key exclusion criteria | Current exclusion criteria as of 11/03/2022: 1. Acute suicidal tendency 2. Severe self-harming behavior, requiring medical care within last 6 months 3. Substance abuse (excluding nicotine) within last 6 months 4. Psychotic symptoms within last 6 months 5. Ongoing trauma therapy (i.e. specific trauma exposure techniques) (These were changed before the first participant was recruited.) _____ Previous exclusion criteria: 1. Acute suicidal tendency 2. Severe self-harming behavior, requiring medical care within last 6 months 3. Substance abuse (excluding nicotine) within last 6 months 4. Psychotic symptoms within last 6 months |
| Date of first enrolment | 09/12/2021 |
| Date of final enrolment | 03/11/2022 |
Locations
Countries of recruitment
- Germany
Study participating centre
Bochum
44791
Germany
Sponsor information
Hospital/treatment centre
Alexandrinenstr. 1-3
Bochum
44791
Germany
| Phone | +49-234-5077-3333 |
|---|---|
| info-uk@lwl.org | |
| Website | http://psychosomatik.lwl-uk-bochum.de/ |
"ROR" |
https://ror.org/04nkkrh90 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Ruhr University Bochum, RUB
- Location
- Germany
Results and Publications
| Intention to publish date | 01/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Editorial Notes
17/06/2024: The intention to publish date was changed from 01/12/2023 to 01/12/2024.
10/08/2023: The overall study end date was changed from 01/07/2023 to 13/06/2023.
27/01/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/12/2022 to 03/11/2022.
18/10/2022: The following changes were made to the trial record:
1. The overall end date was changed from 01/05/2023 to 01/07/2023.
2. The recruitment end date was changed from 01/10/2022 to 01/12/2022.
3. The plain English summary was updated to reflect these changes.
11/03/2022: The following changes were made to the trial record:
1. The inclusion criteria were changed. These were changed before the first participant was recruited.
2. The exclusion criteria were changed. These were changed before the first participant was recruited.
15/12/2021: The recruitment start date was changed from 02/11/2021 to 09/12/2021.
29/10/2021: Trial's existence confirmed by Ethikkommission der Fakultät für Medizin an der Ruhr-Universität Bochum.
