NCT05678361

Brief Summary

Intrusive memories represent a debilitating core feature of PTSD, one of the most prevalent psychiatric disorders following trauma. Exposure therapy is amongst the most successful treatments of PTSD that is recommended by most of the current national and international guidelines. The current study aims to test whether sleep as adjunct to written exposure sessions, a type of exposure- based treatment for PTSD, may boost the effectiveness of the therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

4.3 years

First QC Date

September 17, 2018

Last Update Submit

January 4, 2023

Conditions

Intrusive MemoriesPTSD

Keywords

sleepmemoryconsolidation

Outcome Measures

Primary Outcomes (4)

  • Clinician- assessed Posttraumatic stress symptom severity at 1 week

    Clinician- assessed PTSD symptom severity (CAPS- 5)

    One week post- treatment

  • Self-reported Posttraumatic stress symptom severity at 1 week

    Self - reported PTSD symptom severity (PCL-5)

    One week post- treatment

  • Clinician- assessed Posttraumatic stress symptom severity at 1 month

    Clinician- assessed PTSD symptom severity (CAPS- 5)

    One month post- treatment

  • Self-reported Posttraumatic stress symptom severity at 1 month

    Self - reported PTSD symptom severity (PCL-5)

    One month post- treatment

Secondary Outcomes (4)

  • Total sleep time

    Immediately after written exposure therapy

  • Time spent in N1 sleep

    Immediately after written exposure therapy

  • Time spent in N2 sleep

    Immediately after written exposure therapy

  • Time spent in N3 sleep

    Immediately after written exposure therapy

Study Arms (2)

Sleep after exposure

EXPERIMENTAL

Participants take a nap during 90 min following three exposure (WET) sessions.

Behavioral: Sleep/Nap

Wake after exposure

NO INTERVENTION

Participants watch a 90 min documentary following three exposure (WET) sessions.

Interventions

Sleep/NapBEHAVIORAL

Participants sleep after a maximum of three sessions of exposure therapy.

Sleep after exposure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM V criteria of PTSD (at least moderate symptoms in two categories)
  • Currently receiving Written Exposure Therapy at one of the psychotherapy centers at the Psychiatric University Clinic (PUC).
  • Not more than moderate alcohol consumption (not more than 5 alcoholic drinks/week).
  • Ability to understand the study instructions

You may not qualify if:

  • Travel over \> 3 time zones in \< 3 months
  • head injury
  • shift work
  • current substance abuse
  • neurological disease
  • drug addiction
  • Current suicidality
  • Acute psychotic symptoms
  • Pregnancy
  • Claustrophobia
  • Magnetic resonance imaging incompatibility:
  • Cardiac pacemaker or other metallic implants (e.g. metallic cardiac valve, insulin pump)
  • Metallic foreign particles (e.g. after bullet wound, shell splinter, clips, metal prostheses)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric University Hospital

Zurich, Canton of Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Birgit Kleim, PhD

    Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Psychotherapists and outcome assessors are blind to participants' group membership (i.e., sleep versus wake after exposure therapy)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

January 10, 2023

Study Start

August 1, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 10, 2023

Record last verified: 2023-01

Locations

CH(1)