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Effects of Amygdala Neurofeedback on Depressive Symptoms

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Kymberly Young, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02709161
First received: March 10, 2016
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Major Depressive Disorder
Behavioral: real-time fMRI neurofeedback: Amygdala
Behavioral: real-time fMRI neurofeedback: HIPS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Amygdala Neurofeedback on Depressive Symptoms

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Beck Depression Inventory (BDI-II) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PROMIS Item Bank v1.0 - Depression [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2016
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: real-time fMRI neurofeedback: Amygdala
Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.
Behavioral: real-time fMRI neurofeedback: Amygdala
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
Active Comparator: real-time fMRI neurofeedback: HIPS
HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.
Behavioral: real-time fMRI neurofeedback: HIPS
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • right-handed adults
  • ages 18 - 55
  • primary diagnosis of MDD for recurrent MDD who are currently depressed
  • able to give written informed consent prior to participation
  • unmedicated OR are stable on an unsuccessful antidepressant regime (at least 4 weeks to ensure symptoms are stable). Effective medications will not be discontinued for the purposes of the study.

Exclusion Criteria:

  • clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder
  • alcohol and/or substance dependence (other than nicotine) within 12 months prior to screening
  • history of traumatic brain injury
  • unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body)
  • currently pregnant or breast feeding
  • unable to complete questionnaires written in English
  • current (within 3 weeks of testing) use of any antipsychotics, anticonvulsants, stimulants, benzodiazepines, beta-blockers, or other medications (except antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study. I
  • diagnosis of psychotic or organic mental disorder, bipolar I or II disorder.
  • eye problems or difficulties in corrected vision.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02709161

Contacts
Contact: Kymberly Young, PhD youngk@pitt.edu
Contact: Lisa Stupar 412-383-8100 stuparlm@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Kymberly Young, PhD       youngk@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
  More Information

Responsible Party: Kymberly Young, Assistant Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02709161     History of Changes
Other Study ID Numbers: PRO16010381 
Study First Received: March 10, 2016
Last Updated: October 26, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University of Pittsburgh:
neurofeedback
major depressive disorder
amygdala

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on December 06, 2016