Intrusive MemoriesNCT02552654
Cortisol and the Formation of Intrusive Memories
A study testing Stress Film and Hydrocortisone in people with Intrusive Memories, run by Charite University, Berlin, Germany.
Trial summary
Intrusive memories of traumatic events are core features of posttraumatic stress disorder (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this study was to determine whether cortisol levels during an intrusion-inducing stressor influence subsequent intrusive memories. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrusive Memories
- What is being tested?
- Stress Film and Hydrocortisone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jan 2016
- 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 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy participants
- German on a native level
Who cannot join
- former or present DSM IV Axis I disorders
- physical illnesses
- any medication intake (except oral contraceptive)
- history of sexual abuse or rape
- pregnancy or lactation period
About this study
Official title: Cortisol and the Formation of Intrusive Memories: An Experimental Approach With a Trauma Film Paradigm
Intrusive memories of traumatic events are core features of posttraumatic stress disorder (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this study was to determine whether cortisol levels during an intrusion-inducing stressor influence subsequent intrusive memories.
Read the detailed description
The investigators conducted an experimental, double-blind, placebo-controlled study in 60 healthy women. Prior to watching an established trauma film paradigm that induces short lasting intrusions, participants received a single dose of either 10 mg hydrocortisone or placebo. The number of consecutive intrusions of the trauma film, the mean vividness of the intrusions and the mean degree of distress evoked by the intrusions were assessed during the following seven days. Salivary cortisol and alpha-amylase were collected at seven time points prior to, and after the trauma film.
- Conditions
- Intrusive Memories
- Being tested
- Stress Film, Hydrocortisone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress FilmBehavioural
Film scene with severe physical and sexual violence.
HydrocortisoneDrug
10mg
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone and Stress Film | Experimental | Administration of 10mg hydrocortisone before the trauma film. Receives: Behavioral: Stress Film; Drug: Hydrocortisone |
| Placebo and Stress Film | Experimental | Administration of placebo before the trauma film. Receives: Behavioral: Stress Film; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intrusive memories
Measured with an intrusion diary
Measured: seven consecutive days
Secondary outcomes (2)
Vividness of intrusive memories
Measured with an intrusion diary
Measured: seven consecutive days
Degree of distress of intrusive memories
Measured with an intrusion diary
Measured: seven consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrusive MemoriesStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felicitas Rombold, Charite University, Berlin, Germany
- Investigators
- Stefan Roepke, Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552654
- Sponsor's protocol ID
- Rombold_02
- Status last verified
- Sep 2016
- First submitted
- 16 Sep 2015
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortisol and the Formation of Intrusive Memories: An Experimental Approach With a Trauma Film Paradigm
- ClinicalTrials.gov ID
- NCT02552654
- Acronym / sponsor ID
- Rombold_02
- Conditions
- Intrusive Memories
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 17 Sep 2015 (estimated)
- 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.
Intrusive memories of traumatic events are core features of posttraumatic stress disorder (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this study was to determine whether cortisol levels during an intrusion-inducing stressor influence subsequent intrusive memories.
Detailed description
The investigators conducted an experimental, double-blind, placebo-controlled study in 60 healthy women. Prior to watching an established trauma film paradigm that induces short lasting intrusions, participants received a single dose of either 10 mg hydrocortisone or placebo. The number of consecutive intrusions of the trauma film, the mean vividness of the intrusions and the mean degree of distress evoked by the intrusions were assessed during the following seven days. Salivary cortisol and alpha-amylase were collected at seven time points prior to, and after the trauma film.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone and Stress Film | Experimental | Behavioral: Stress Film, Drug: HydrocortisoneAdministration of 10mg hydrocortisone before the trauma film. |
| Placebo and Stress Film | Experimental | Behavioral: Stress Film, Drug: PlaceboAdministration of placebo before the trauma film. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy participants
- German on a native level
Key exclusion criteria (5 listed)
- former or present DSM IV Axis I disorders
- physical illnesses
- any medication intake (except oral contraceptive)
- history of sexual abuse or rape
- pregnancy or lactation period
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 |
|---|---|---|
| Stress FilmFilm scene with severe physical and sexual violence. | Behavioural | Hydrocortisone and Stress Film, Placebo and Stress Film |
| Hydrocortisone10mg | Drug | Hydrocortisone and Stress Film |
| Placebo | Drug | Placebo and Stress Film |
Primary outcome
Number of intrusive memories
Time frame: seven consecutive days
Measured with an intrusion diary
2 secondary outcomes
Vividness of intrusive memories
Time frame: seven consecutive days
Degree of distress of intrusive memories
Time frame: seven consecutive days
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 3 Oct 2016.
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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.
Stefan Roepke study director
Charite University, Berlin, Germany
Questions about this trial
What is this clinical trial studying?
A study testing Stress Film and Hydrocortisone in people with Intrusive Memories, run by Charite University, Berlin, 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 5 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 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of intrusive memories (time frame: seven consecutive days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2016.