SLEPT: Sleep's Influence on the Treatment of Intrusive Emotional

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT05678361
• Collaborator: Psychiatric University Hospital, Zurich (Other)
• Enrollment: 42
• Location: 1
• Arms: 2
• Actual Duration (Months): 52
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intrusive Memories; PTSD	Behavioral: Sleep/Nap	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomised controlled trialRandomised controlled trial
• Masking: Double (Care Provider, Outcomes Assessor)
• Masking Description: Psychotherapists and outcome assessors are blind to participants' group membership (i.e., sleep versus wake after exposure therapy)
• Primary Purpose: Treatment
• Official Title: Sleep's Influence on the Treatment of Intrusive Emotional Memories With Trauma-focused CBT
• Actual Study Start Date: Aug 1, 2018
• Actual Primary Completion Date: Dec 1, 2022
• Actual Study Completion Date: Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Clinician- assessed Posttraumatic stress symptom severity at 1 week [One week post- treatment]

   Clinician- assessed PTSD symptom severity (CAPS- 5)

2. Self-reported Posttraumatic stress symptom severity at 1 week [One week post- treatment]

   Self - reported PTSD symptom severity (PCL-5)

3. Clinician- assessed Posttraumatic stress symptom severity at 1 month [One month post- treatment]

   Clinician- assessed PTSD symptom severity (CAPS- 5)

4. Self-reported Posttraumatic stress symptom severity at 1 month [One month post- treatment]

   Self - reported PTSD symptom severity (PCL-5)

Secondary Outcome Measures

1. Total sleep time [Immediately after written exposure therapy]

   Total sleep time according to EEG

2. Time spent in N1 sleep [Immediately after written exposure therapy]

   N1 time according to EEG

3. Time spent in N2 sleep [Immediately after written exposure therapy]

   N2 time according to EEG

4. Time spent in N3 sleep [Immediately after written exposure therapy]

   N3 time according to EEG

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Psychiatric University Hospital	Zürich	Zurich	Switzerland	8032

Sponsors and Collaborators

• University of Zurich
• Psychiatric University Hospital, Zurich

Investigators

• Principal Investigator: Birgit Kleim, PhD, Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT05678361
• Other Study ID Numbers: 2016-01357
• First Posted: Jan 10, 2023
• Last Update Posted: Jan 10, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Zurich: sleep; memory; consolidation

Study Results

No Results Posted as of Jan 10, 2023