The primary objective of this study is to test whether deepening post-treatment sleep each night of a 5-day treatment program for PTSD using EEG-guided acoustic stimulation, will result an augmented overall treatment effect. In addition, two…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PTSD symptom level post-treatment (1 week and 3 months after end of treatment)
is measured with the Clinician-administered PTSD scale for DSM-5 (CAPS-5,
previous week version) and the self-administrated PTSD checklist for DSM-5
(PCL-5).
Secondary outcome
Related to the secondary objective 1, the subjective ratings related to the
traumatic memories under treatment measured with the index Trauma Memory
Interview (ITMI) will be obtained at the beginning and end of each treatment
day and the following day. During the interview heart rate will be measured
using an ambulatory heart rate monitor. Also, at the beginning of each
treatment day the PTSD symptom level (PCL-5) will be assessed.
Related to the secondary objective 2, the objective sleep depth, sleep
continuity measures, sleep architecture measures, and other physiological sleep
measures will be obtained during each night of treatment. Also, sleep quality
will be measured with a sleep diary.
Background summary
Post-traumatic stress disorder (PTSD) is a severe and highly prevalent
psychiatric disorder in which traumatic memories result in debilitating
symptoms such as flashbacks and nightmares. With one-third of patients not
responding to standard psychotherapy, new treatment strategies are urgently
needed. Sleep represents a unique time-window to enhance therapeutic
interventions. Traumatic memories that are neutralized in therapy need to be
stored back into memory during deep sleep to solidify the treatment effect.
Sleep however, is typically disturbed in PTSD. Studies in healthy individuals
now show that sleep can be deepened and memory storage can be boosted by
EEG-guided acoustic stimulation. Yet despite its clinical potential, this
technique has rartely been tested in patients.
Study objective
The primary objective of this study is to test whether deepening post-treatment
sleep each night of a 5-day treatment program for PTSD using EEG-guided
acoustic stimulation, will result an augmented overall treatment effect. In
addition, two secondary objectives will be investigated: 1. To test whether
deepening sleep each night of the 5-day treatment program for PTSD, will result
in an augmented treatment effect of the daily treatment session, and 2. To test
whether diverse sleep parameters, measured during each night of the 5-day
treatment program for PTSD are associated to the effect of sleep deepening.
Study design
We will perform a double-blind, randomized, sham-controlled, between-subjects
study to test the effectiveness of sleep deepening as augmentation strategy for
PTSD.
Intervention
During each night of a 5-day treatment program for PTSD, we will use
ambulatory, EEG-guided, closed-loop stimulation to administer subtle,
non-arousing sounds, phase-locked to the up-phase of slow waves (SWs) during
deep (non-REM) sleep (intervention group). In the control group, the same
set-up is used to detect SWs but no acoustic stimuli are presented (sham
stimulation).
Study burden and risks
Total participation time will be approximately 69 hours, consisting of 5 hours
of clinical interviews and questionnaires and 8 nights of sleep recording (3
baseline and 5 treatment nights). The risk associated with participation can be
considered neglectable and the burden also minimal. No adverse effects of sleep
deepening have been reported.
de Boelenlaan 1108
Amsterdam 1081HZ
NL
de Boelenlaan 1108
Amsterdam 1081HZ
NL
Listed location countries
Age
Inclusion criteria
- PTSD diagnosis according to DSM-5 criteria as assessed with the
Clinician-administered PTSD scale for DSM-5 (CAPS-5, previous month version)
- Indication to receive 5-day treatment program for PTSD
- 18-65 years of age
Exclusion criteria
- Current episode of psychotic or bipolar disorder or alcohol or drug dependence
- Use of benzodiazepines or other sleep medication during study period
- Use of other psychotropic medication than benzodiazepines/sleep medication,
except when on a stable dose for at least 6 weeks (after start or alteration of
dosage)
- Irregular sleep/wake rhythm (outside PTSD itself) (imposed by e.g. regular
nightshifts or cross timeline travel)
- Severe hearing loss
- Sleeping on stomach
- Inability to understand or meet the study requirements, as assessed by the
researchers
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83671.018.23 |