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Completed

NCT Number: NCT02552654

Cortisol and the Formation of Intrusive Memories

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.

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Key information

Conditions

Intrusive Memories

Age range

18 year–34 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy participants
  • German on a native level

Exclusion criteria

  • 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

Treatment and study plan

Stress Film

Behavioral

Film scene with severe physical and sexual violence.

Hydrocortisone

Drug

10mg

Placebo

Drug

Primary outcomes

  1. Number of intrusive memories

    Time frame: seven consecutive days

    Measured with an intrusion diary

Secondary outcomes

  1. Vividness of intrusive memories

    Time frame: seven consecutive days

    Measured with an intrusion diary

  2. Degree of distress of intrusive memories

    Time frame: seven consecutive days

    Measured with an intrusion diary

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Cortisol and the Formation of Intrusive Memories: An Experimental Approach With a Trauma Film Paradigm

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 17, 2015
Registry last updated
Oct 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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