Clinical trial NCT04303533: Regulation of Amygdala Via Neurofeedback in PTSD After Childhood Sexual Abuse
Official title: Regulation of Amygdala Via Neurofeedback in PTSD After Childhood Sexual Abuse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PTSD
Keywords: Neuro-Feedback
Childhood Sexual Abuse
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv University
First posted: 2020-03-11
Enrollment: 4
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Post-traumatic stress disorder (PTSD) is a common debilitating disorder that affects many individuals exposed to aversive events. The severity of PTSD symptoms is positively correlated with amygdala activation. More severe PTSD symptoms following exposure to stressful events, are associated with amygdala hyper-responsivity prior to exposure. A possible intervention for PTSD is Neurofeedback (NF) - a treatment method based on learned self-modulation of neural activity in response to feedback of neural signal. Previous work in the investigator's lab established a NF training procedure that utilizes the temporal abilities of EEG with the spatial advantages of fMRI. Further work based on this method using the amygdala BOLD signal (EEG-finger-print, EFP) has demonstrated a potential for improving the ability to self-regulate amygdala activity and to improve emotional regulation in a healthy population. The current study aims to investigate the potential of this method as a therapeutic intervention for PTSD among men with a history of childhood sexual abuse (CSA).

Detailed description: Pretreatment phase- All participants will undergo clinician evaluation and self-report measures in TASMC. In addition, they will receive a WatchPAT (wearable technology) for tracking sleep for 2 nights.

Participants will receive 10 sessions of NF-EFP once a week for ten weeks. NF-EFP sessions: For the duration of each NF-EFP session the participant will be seated comfortably in front of a computer screen. A staff member will explain the goal of the meeting to the participant, present the equipment to be used and describe the course of the meeting. The EEG-NF practice will consist of four-minute segments repeated for up to 30 minutes. During each practice segment the participant will be asked to modify visual media that provides feedback on the degree of successful brain training. The duration of one session is approximately 45 minutes.

Post treatment phase -All participants will undergo clinician evaluation and self-report measures in TASMC. In addition, they will receive a WatchPAT (wearable technology) for tracking sleep for 2 nights.

Eligibility criteria: Inclusion Criteria:

Treated at Clinic for Sexual Assault with stable symptoms. Fulfill screening criteria of DSM-V for PTSD.

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Exclusion Criteria:

* Fulfill screening criteria of DSM-V for psychosis. Substance dependence or abuse other than nicotine. Diagnosis of a neurodegenerative disease. Acute illness that could be worsen by the treatment. -

Primary outcomes:
measure: Clinical measures- PSTD symptoms
timeFrame: [ Time Frame: The clinical assessment will be administrated at pre-treatment (baseline) and post-treatment (up to two weeks post-treatment)
Secondary outcomes:
measure: Sleep quality- REM latency and sleep latency
timeFrame: [ Time Frame: Two nights; first, at pre-treatment (baseline) and second, post-treatment (up to two weeks post-treatment).
measure: Self-report questionnaires- PCL (PTSD checklist )
timeFrame: The Self-report questionnaires will be administrated: pre-treatment (baseline), post-treatment (up to two weeks post-treatment).
measure: self-report questionnaires- Beck Depression Inventory (BDI-II)
timeFrame: Time Frame: The Self-report questionnaires will be administrated: pre-treatment (baseline), post-treatment (up to two weeks post-treatment).
measure: Self-report questionnaires- State-trait Anxiety Inventory (STAI)
timeFrame: Time Frame: The Self-report questionnaires will be administrated: pre-treatment (baseline), post-treatment (up to two weeks post-treatment).
measure: Self-report questionnaires- Toronto Alexithymia Scale (TAS)
timeFrame: Time Frame: The Self-report questionnaires will be administrated: pre-treatment (baseline), post-treatment (up to two weeks post-treatment)
measure: Self-report questionnaires- Dissociative Experience Scale (DES)
timeFrame: ime Frame: The Self-report questionnaires will be administrated: pre-treatment (baseline), post-treatment (up to two weeks post-treatment).
measure: Self-report questionnaires- Locus of Control (LOC)
timeFrame: ime Frame: The Self-report questionnaires will be administrated: pre-treatment (baseline), post-treatment (up to two weeks post-treatment).
Other outcomes:
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