Cortisol and the Formation of Intrusive Memories

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.

Study Overview

• Status: Completed
• Conditions: Intrusive Memories
• Intervention / Treatment: Drug: Placebo; Behavioral: Stress Film; Drug: Hydrocortisone

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hydrocortisone and Stress Film; Administration of 10mg hydrocortisone before the trauma film.	Behavioral: Stress Film; Film scene with severe physical and sexual violence.; Drug: Hydrocortisone; 10mg
EXPERIMENTAL: Placebo and Stress Film; Administration of placebo before the trauma film.	Drug: Placebo; Behavioral: Stress Film; Film scene with severe physical and sexual violence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of intrusive memories	Measured with an intrusion diary	seven consecutive days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vividness of intrusive memories	Measured with an intrusion diary	seven consecutive days
Degree of distress of intrusive memories	Measured with an intrusion diary	seven consecutive days

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Director: Stefan Roepke, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: September 16, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (ESTIMATE): September 17, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): October 3, 2016
• Last Update Submitted That Met QC Criteria: September 30, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Inflammatory Agents; Hydrocortisone
• Other Study ID Numbers: Rombold_02