Intrusive MemoriesSLEPTNCT05678361
Sleep's Influence on the Treatment of Intrusive Emotional
A study testing Sleep/Nap in people with Intrusive Memories and PTSD, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intrusive Memories, PTSD
- What is being tested?
- Sleep/Nap
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2018to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Travel over > 3 time zones in < 3 months
- head injury
- shift work
- current substance abuse
- neurological disease
- drug addiction
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- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Psychiatric University Hospital
Zurich, Canton of Zurich, 8032
About this study
Official title: 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.
Read the 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.
- Conditions
- Intrusive Memories, PTSD
- Being tested
- Sleep/Nap
- Keywords
- sleep, memory, consolidation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep/NapBehavioural
Participants sleep after a maximum of three sessions of exposure therapy.
| Study group | Role | What they receive |
|---|---|---|
| Sleep after exposure | Experimental | Participants take a nap during 90 min following three exposure (WET) sessions. Receives: Behavioral: Sleep/Nap |
| Wake after exposure | No intervention | Participants watch a 90 min documentary following three exposure (WET) sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician- assessed Posttraumatic stress symptom severity at 1 week
Clinician- assessed PTSD symptom severity (CAPS- 5)
Measured: One week post- treatment
Self-reported Posttraumatic stress symptom severity at 1 week
Self - reported PTSD symptom severity (PCL-5)
Measured: One week post- treatment
Clinician- assessed Posttraumatic stress symptom severity at 1 month
Clinician- assessed PTSD symptom severity (CAPS- 5)
Measured: One month post- treatment
Self-reported Posttraumatic stress symptom severity at 1 month
Self - reported PTSD symptom severity (PCL-5)
Measured: One month post- treatment
Secondary outcomes (4)
Total sleep time
Total sleep time according to EEG
Measured: Immediately after written exposure therapy
Time spent in N1 sleep
N1 time according to EEG
Measured: Immediately after written exposure therapy
Time spent in N2 sleep
N2 time according to EEG
Measured: Immediately after written exposure therapy
Time spent in N3 sleep
N3 time according to EEG
Measured: Immediately after written exposure therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Aug 2018
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrusive MemoriesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Psychiatric University Hospital, Zurich
- Responsible party
- Sponsor
- Investigators
- Birgit Kleim, PhD, Principal investigator, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678361
- Sponsor's protocol ID
- 2016-01357
- Other IDs
- 2016
- Acronym
- SLEPT
- Status last verified
- Jan 2023
- First submitted
- 17 Sep 2018
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep's Influence on the Treatment of Intrusive Emotional Memories With Trauma-focused CBT
- ClinicalTrials.gov ID
- NCT05678361
- Acronym / sponsor ID
- SLEPT / 2016-01357
- Conditions
- Intrusive Memories, PTSD
- Keywords
- sleep, memory, consolidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Psychiatric University Hospital, Zurich
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Sleep after exposure | Experimental | Behavioral: Sleep/NapParticipants take a nap during 90 min following three exposure (WET) sessions. |
| Wake after exposure | No intervention | –Participants watch a 90 min documentary following three exposure (WET) sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Travel over > 3 time zones in < 3 months
- head injury
- shift work
- current substance abuse
- neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep/NapParticipants sleep after a maximum of three sessions of exposure therapy. | Behavioural | Sleep after exposure |
Primary outcome
Clinician- assessed Posttraumatic stress symptom severity at 1 week
Time frame: One week post- treatment
Clinician- assessed PTSD symptom severity (CAPS- 5)
Self-reported Posttraumatic stress symptom severity at 1 week
Time frame: One week post- treatment
Self - reported PTSD symptom severity (PCL-5)
Clinician- assessed Posttraumatic stress symptom severity at 1 month
Time frame: One month post- treatment
Clinician- assessed PTSD symptom severity (CAPS- 5)
Self-reported Posttraumatic stress symptom severity at 1 month
Time frame: One month post- treatment
Self - reported PTSD symptom severity (PCL-5)
4 secondary outcomes
Total sleep time
Time frame: Immediately after written exposure therapy
Time spent in N1 sleep
Time frame: Immediately after written exposure therapy
Time spent in N2 sleep
Time frame: Immediately after written exposure therapy
Time spent in N3 sleep
Time frame: Immediately after written exposure therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgit Kleim, PhD principal investigator
Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep/Nap in people with Intrusive Memories and PTSD, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician- assessed Posttraumatic stress symptom severity at 1 week (time frame: One week post- treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.