Neurofeedback Therapeutic Intervention For Post-Traumatic Stress Disorder Patients Compared To Treatment As Usual

NCT02544971 | Unknown

• 1 other identifier: 0215-15-TLV
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 our 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.

Conditions

PTSD

Outcome Measures

Primary Outcomes (2)

• Decreased PTSD symptoms measured by change in psychiatric evaluation and PCL score

  Psychiatric evaluation is based on amount and severity of symptoms according to DSM-IV/V. We will also base change in symptoms on a statistically significant change in PCL (PTSD Check List) score

  1-14 weeks

• Reduced amygdala reactivity measured by percent change in BOLD signal

  1-14 weeks

Secondary Outcomes (3)

• Change in Emotion Regulation Questionnaire (ERQ)

  1-14 weeks

• Change in State/Trait Anxiety Inventory (STAI)

  1-14 weeks

• Change in Beck Depression Inventory (BDI-II)

  1-14 weeks

Study Arms (3)

NF-N group

EXPERIMENTAL

Neurofeedback in a neutral context

Behavioral: Neurofeedback

NF-T group

ACTIVE COMPARATOR

Neurofeedback in a trauma-related context

Behavioral: Neurofeedback

Control group

ACTIVE COMPARATOR

Treatment as usual

Other: Control

Interventions

Neurofeedback BEHAVIORAL

Neurofeedback is based on the learned change in a particular neural signal or a combination of neural signals when feedback and reward of these signals are repeatedly presented to the organism. Thus, individuals learn to modulate their neural activity through a closed NF loop.

NF-N group; NF-T group

Control OTHER

Treatment as usual

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic Post traumatic stress disorder (PTSD) (at least one year and two months since diagnosis; diagnosis according to DSM-V, or DSM-VI)
• Patients must meet the criteria for medical MRI testing set by Tel Aviv Sourasky Medical Center

You may not qualify if:

• Patients diagnosed with another major psychiatric disorder other than PTSD (such as schizophrenia).
• Patients diagnosed with substance abuse.
• Any aggravation of PTSD symptoms that requires hospitalization.
• Patients who are unable to commit to the duration and plan of the study.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Whol Institute for Advanced Imaging, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Talma Hendler, MD, PhD

  Tel Aviv University Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 9, 2015
• Study Start: April 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: June 1, 2019
• Last Updated: March 6, 2018

Record last verified: 2018-03

Locations

IL (1)