Sleep's Influence on the Treatment of Intrusive Emotional

PTSD Clinical Trial

— SLEPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05678361
• Other study ID #: 2016-01357
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Intrusive Memories
• PTSD

Intervention

Behavioral:
• Sleep/Nap
Participants sleep after a maximum of three sessions of exposure therapy.

Locations

Country	Name	City	State
Switzerland	Psychiatric University Hospital	Zürich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Psychiatric University Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician- assessed Posttraumatic stress symptom severity at 1 week	Clinician- assessed PTSD symptom severity (CAPS- 5)	One week post- treatment
Primary	Self-reported Posttraumatic stress symptom severity at 1 week	Self - reported PTSD symptom severity (PCL-5)	One week post- treatment
Primary	Clinician- assessed Posttraumatic stress symptom severity at 1 month	Clinician- assessed PTSD symptom severity (CAPS- 5)	One month post- treatment
Primary	Self-reported Posttraumatic stress symptom severity at 1 month	Self - reported PTSD symptom severity (PCL-5)	One month post- treatment
Secondary	Total sleep time	Total sleep time according to EEG	Immediately after written exposure therapy
Secondary	Time spent in N1 sleep	N1 time according to EEG	Immediately after written exposure therapy
Secondary	Time spent in N2 sleep	N2 time according to EEG	Immediately after written exposure therapy
Secondary	Time spent in N3 sleep	N3 time according to EEG	Immediately after written exposure therapy