Effects of Amygdala Neurofeedback on Depressive Symptoms
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to determine the clinical efficacy of augmenting
      cognitive-behavioral therapy with real-time functional magnetic resonance imaging
      neurofeedback (rtfMRI-nf) training to increase the amygdala's response to positive
      autobiographical memories.
    

Detailed description: 
      Previous research has shown that real-time fMRI neurofeedback (rtfMRI-nf) training aimed at
      increasing the amygdala's response to positive autobiographical memory recall holds
      therapeutic potential for treating patients with major depressive disorder (MDD), as
      clinically significant decreases in clinician administered and self-report measures of
      depression severity were observed following two rtfMRI amygdala neurofeedback sessions.
      Furthermore, rtfMRI amygdala neurofeedback changed emotional processing towards a positive
      bias. As this rtfMRI-nf procedure utilizes principles of cognitive-behavioral therapy (CBT),
      including restructuring thoughts and emotional processing towards the positive, the current
      study seeks to examine the effects of augmenting CBT with amygdala rtfMRI-nf. Specifically,
      the investigators plan to test the hypothesis that pretreatment with two amygdala rtfMRI-nf
      sessions prior to the the start of CBT will result in a higher percentage of patients who
      exhibit 'sudden gains' (a between session drop of at least 25% on the Beck Depression
      Inventory associated with better treatment response) compared to those who receive rtfMRI-nf
      from a parietal control region putatively not involved in emotional processing. Over the
      course of three years, 60 participants diagnosed with MDD and planning to start CBT will be
      recruited through the clinical services of the Western Psychiatric Institute and Clinic
      (WPIC) and through licensed CBT therapists in the Pittsburgh metropolitan area. Participants
      will undergo two rtfMRI-nf sessions within the two weeks prior to starting therapy. Half of
      the participants will receive amygdala neurofeedback and half will receive control
      neurofeedback. At weeks 1-3 and 9 & 10 following the start of therapy, the participant will
      complete the BDI-II and the NIH Patient Reported Outcomes Measurement Information System
      (PROMIS) Depression measure. The number of patients who meet criteria for sudden gains and
      the average session at which this occurred will be compared between CBT + amygdala rtfMRI-nf
      and CBT + control rtfMRI-nf groups. Success will suggest a new method for improving outcomes
      to CBT in depressed patients.
    

Intervention name(s): real-time fMRI neurofeedback: Amygdala; real-time fMRI neurofeedback: HIPS
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories; Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neurofeedback; major depressive disorder; amygdala