Sleep's Influence on the Treatment of Intrusive Emotional (SLEPT)

Sleep's Influence on the Treatment of Intrusive Emotional Memories With Trauma-focused CBT

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.

Study Overview

• Status: Completed
• Conditions: PTSD; Intrusive Memories
• Intervention / Treatment: Behavioral: Sleep/Nap

Detailed Description

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. However, not all patients benefit equally and only about 50% show sustained response. There is thus room for improvement in terms of (i) better understanding who benefits from this type of therapy and (ii) possible ways of augmenting existing trauma-focused therapies. The current study aims to contribute to these endevours. Specifically, the 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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8032
      • Psychiatric University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Travel over > 3 time zones in < 3 months
• head injury
• shift work
• current substance abuse
• neurological disease
• drug addiction
• Current suicidality

Specific exclusion criteria for the fMRI:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep after exposure; Participants take a nap during 90 min following three exposure (WET) sessions.	Behavioral: Sleep/Nap; Participants sleep after a maximum of three sessions of exposure therapy.
No Intervention: Wake after exposure; Participants watch a 90 min documentary following three exposure (WET) sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total sleep time	Total sleep time according to EEG	Immediately after written exposure therapy
Time spent in N1 sleep	N1 time according to EEG	Immediately after written exposure therapy
Time spent in N2 sleep	N2 time according to EEG	Immediately after written exposure therapy
Time spent in N3 sleep	N3 time according to EEG	Immediately after written exposure therapy

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Psychiatric University Hospital, Zurich
• Investigators: Principal Investigator: Birgit Kleim, PhD, Zurich

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Estimate): January 10, 2023

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: memory; sleep; consolidation
• Other Study ID Numbers: 2016-01357

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No