The goal of this interventional double-blind study is to demonstrate the safety and efficacy of PRISM neurofeedback training within an MDD Anhedonia sample. The goals of this study include: 1. Demonstrating the safety and efficacy of Prism Neurofeedback training within an MDD Anhedonia sample; 2. Identifying clinical profile/symptoms-based biomarkers (e.g., Hamilton Depression Rating Scale - HDRS-21, Dimensional Anhedonia Rating Scale - DARS, Snaith-Hamilton Pleasure Scale for Clinicians SHAPS) scores that can be used by clinics to administer Prism therapy in conjunction with standard of care (SOC) therapy; 3. Producing initial guidelines for integrating Prism neurofeedback training for MDD therapy with MDD Anhedonia (SOC). Participants will be randomly assigned to one of two arms, Active, or Sham.
During the study, participants will perform the following: * Complete clinical assessments using questionnaires, an MRI scan, and tasks that probe reward responsivity, learning, and motivation. * Perform at least 10 sessions but optimally 15 (+/-3) neurofeedback training sessions (performed twice a week on nonconsecutive days for 5-8 weeks). * Complete the same clinical assessments, post-NF training MRI scan, and tasks same as in the screening/baseline stage. Researchers will compare the sham and treatment arm to evaluate if the neurofeedback effect reduced MDD symptoms in MDD patients with Anhedonia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
19
A minimum of 10 and up to 15 active NF Prism training sessions, aimed to train for upregulating the RS activity. Sessions will occur twice a week, on nonconsecutive days, over 5-8 consecutive weeks. Subjects will also receive two single booster sessions, one month and two months after their last training session.
a minimum of 10 and up to 15 sham NF Prism training sessions, aimed to train for upregulating the RS activity. Sessions will occur twice a week, on nonconsecutive days, over 5-8 consecutive weeks. Subjects will also receive two single sham booster sessions, one month and two months after their last training session.
McLean Hospital
Belmont, Massachusetts, United States
HDRS-21
The HDRS (also known as the Ham-D) is the most widely used clinician-administered depression assessment scale. It is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3- or 5-point scale, depending on the item, and the total score is compared to the corresponding descriptor. Assessment time is about 20 minutes.
Time frame: 9 weeks
Snaith Hamilton Pleasure Scale - self reported (SHAPS-SR)
The Snaith Hamilton Pleasure Scale (Snaith et al., 1995) is a 14- item self-administered measure of anhedonic symptoms. The purpose of this assessment is to evaluate the ability to enjoy/experience pleasure in activities in the past week. Each item is rated on a 4-point Likert scale, where the total score ranges between 0 to 42 and a higher total score means a worse outcome.
Time frame: 9 weeks
HDRS-21
The HDRS (also known as the Ham-D) is the most widely used clinician-administered depression assessment scale. It is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3- or 5-point scale, depending on the item, and the total score is compared to the corresponding descriptor. Assessment time is about 20 minutes.
Time frame: 3 months
Snaith Hamilton Pleasure Scale - self reported (SHAPS-SR)
The Snaith Hamilton Pleasure Scale (Snaith et al., 1995) is a 14- item self-administered measure of anhedonic symptoms. The purpose of this assessment is to evaluate the ability to enjoy/experience pleasure in activities in the past week. Each item is rated on a 4-point Likert scale, where the total score ranges between 0 to 42 and a higher total score means a worse outcome.
Time frame: 3 months
The clinical global impression (CGI-I)
The CGI-I Scale - of Clinical Global Impression (Guy et.al, 1976) - is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Rated within the range of 0 to 7, lower scores indicate improved outcomes while higher scores indicate worsen outcomes.
Time frame: 9 weeks
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