Clinical trial NCT05678361: Sleep's Influence on the Treatment of Intrusive Emotional
Official title: Sleep's Influence on the Treatment of Intrusive Emotional Memories With Trauma-focused CBT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrusive Memories
PTSD
Keywords: sleep
memory
consolidation
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Psychiatric University Hospital, Zurich
First posted: 2023-01-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Clinician- assessed Posttraumatic stress symptom severity at 1 week
timeFrame: One week post- treatment
measure: Self-reported Posttraumatic stress symptom severity at 1 week
timeFrame: One week post- treatment
measure: Clinician- assessed Posttraumatic stress symptom severity at 1 month
timeFrame: One month post- treatment
measure: Self-reported Posttraumatic stress symptom severity at 1 month
timeFrame: One month post- treatment
Secondary outcomes:
measure: Total sleep time
timeFrame: Immediately after written exposure therapy
measure: Time spent in N1 sleep
timeFrame: Immediately after written exposure therapy
measure: Time spent in N2 sleep
timeFrame: Immediately after written exposure therapy
measure: Time spent in N3 sleep
timeFrame: Immediately after written exposure therapy
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Psychiatric University Hospital
state: Zurich
Study officials:
affiliation: Zurich
name: Birgit Kleim, PhD
role: PRINCIPAL_INVESTIGATOR
References: