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Completed

NCT Number: NCT05678361

Sleep's Influence on the Treatment of Intrusive Emotional

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatric University Hospital

Zurich, Canton of Zurich, 8032, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sleep/Nap

Behavioral

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

Primary outcomes

  1. Clinician- assessed Posttraumatic stress symptom severity at 1 week

    Time frame: One week post- treatment

    Clinician- assessed PTSD symptom severity (CAPS- 5)

  2. Self-reported Posttraumatic stress symptom severity at 1 week

    Time frame: One week post- treatment

    Self - reported PTSD symptom severity (PCL-5)

  3. Clinician- assessed Posttraumatic stress symptom severity at 1 month

    Time frame: One month post- treatment

    Clinician- assessed PTSD symptom severity (CAPS- 5)

  4. Self-reported Posttraumatic stress symptom severity at 1 month

    Time frame: One month post- treatment

    Self - reported PTSD symptom severity (PCL-5)

Secondary outcomes

  1. Total sleep time

    Time frame: Immediately after written exposure therapy

    Total sleep time according to EEG

  2. Time spent in N1 sleep

    Time frame: Immediately after written exposure therapy

    N1 time according to EEG

  3. Time spent in N2 sleep

    Time frame: Immediately after written exposure therapy

    N2 time according to EEG

  4. Time spent in N3 sleep

    Time frame: Immediately after written exposure therapy

    N3 time according to EEG

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Psychiatric University Hospital, Zurich

Registry information

Official study title

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

Acronym: SLEPT

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 10, 2023
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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