Cortisol and the Formation of Intrusive Memories

NCT ID: NCT02552654

Last Updated: 2016-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-01-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Hydrocortisone and Stress Film

Administration of 10mg hydrocortisone before the trauma film.

Group Type: EXPERIMENTAL

Stress Film

Intervention Type: BEHAVIORAL

Film scene with severe physical and sexual violence.

Hydrocortisone

Intervention Type: DRUG

10mg

Placebo and Stress Film

Administration of placebo before the trauma film.

Group Type: EXPERIMENTAL

Stress Film

Intervention Type: BEHAVIORAL

Film scene with severe physical and sexual violence.

Placebo

Intervention Type: DRUG

Interventions

Stress Film

Film scene with severe physical and sexual violence.

Intervention Type: BEHAVIORAL

Hydrocortisone

10mg

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Felicitas Rombold

Dipl.-Psych.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan Roepke

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Other Identifiers

Rombold_02

Identifier Type: -

Identifier Source: org_study_id