Cortisol and the Formation of Intrusive Memories

Intrusive Memories Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552654
• Other study ID #: Rombold_02
• Status: Completed
• Phase: N/A
• First received: September 16, 2015
• Last updated: September 30, 2016
• Start date: September 2015
• Est. completion date: January 2016

Study information

• Verified date: September 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Intrusive Memories

Intervention

Behavioral:
• Stress Film
Film scene with severe physical and sexual violence.

Drug:
• Hydrocortisone
10mg
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of intrusive memories	Measured with an intrusion diary	seven consecutive days	No
Secondary	Vividness of intrusive memories	Measured with an intrusion diary	seven consecutive days	No
Secondary	Degree of distress of intrusive memories	Measured with an intrusion diary	seven consecutive days	No