Clinical trial NCT05123690: Neurofeedback for Post-Traumatic Stress Disorder
Official title: Neurofeedback for Post-Traumatic Stress Disorder (N-PTSD). A Randomized Trial of Neurofeedback.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-traumatic Stress Disorder
Keywords: Neurofeedback
Electroencephalogram (EEG)
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation is to one of two arms
Primary purpose: TREATMENT

Brief summary: A two-arm randomized pilot of standard neurofeedback and a waiting list for patients with treatment resistent PTSD.

Detailed description: This study will be a randomized-controlled pilot and in a later study virtual reality based neurofeedback will be tested. In this study 30 subjects will be randomised into one of two arms of the study. Treatment as usual (TAU) entails both psychotherapy, medication and other interventions.

1. TAU + Neurofeedback using a PC-screen (experimental group)
2. TAU as a waiting list (control group) - the participants in the control group will be offered to choose one of the two experimental treatments at the end of the trial.

The 30 participants will be randomized to one arm of the study (15 participants per group). The subjects will be recruited from Psychiatric Outpatient Care at Sahlgrenska University Hospital, Crisis and Trauma Center Gothenburg and Psychiatric Care Center in Tranås, Jönköping.

Participants in the experimental group will have 24 sessions in total, (twice a week. 12 week period) with a trained neurofeedback specialist or trained neurofeedback physician. Before session 1 and after session 24, a clinician will fill in the clinical scales and questionnaires.

Eligibility criteria: Inclusion Criteria:

* CAPS Cutoff \>44
* Stable psychopharmacological treatment (stable dose, no planned changes during the course of the trial)
* AUDIT cut off \<16
* DUDIT cut off \<8
* Already undergone at least one treatment with psychotherapy and/or pharmacological treatment for a minimum of 6 months.
* 18 years or older

Exclusion Criteria:

* Diagnosis of traumatic brain injury (TBI) affecting capability to give informed consent
* Ongoing traumatic exposure (such as domestic violence)
* Balance problems
* Active suicide risk or life-threatening self-harm
* A diagnosis of schizophrenia or psychotic disorder
* Ongoing compulsory care
* If the patient changes dose or medication strategy during the trial.
* If the neurofeedback treatment is identified as a primary reason for worsening of participant's well being.

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Impact of Event Scale - Revised (IES-R)
timeFrame: Through study completion, an average of 3 months
measure: Impact of Event Scale - Revised (IES-R)
timeFrame: 4 weeks after finished intervention for the two intervention arms.
measure: Visual Analogue Scale for Wellbeing (VAS-W)
timeFrame: Before and after each session 1-24 for the two intervention arms.
measure: Insomnia Severity Index (ISI)
timeFrame: Through study completion, an average of 3 months
measure: Insomnia Severity Index (ISI)
timeFrame: 4 weeks after finished intervention for the two intervention arms.
measure: Wisconsin Card Sorting Test (WCST)
timeFrame: Through study completion, an average of 3 months
measure: Wisconsin Card Sorting Test (WCST)
timeFrame: 4 weeks after finished intervention, an average of 4 months
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: For those that have finished the intervention CAPS at one month post treatment
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: Västra Götaland
Study officials:
affiliation: Sahlgrenska University Hospital
name: Steinn Steingrimsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: