search
Back to results

Cognitive Process-based Real-time fMRI Neurofeedback in MDD and Rumination (CNF-rumination)

Primary Purpose

Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active neurofeedback
Sham neurofeedback
Sponsored by
Laureate Institute for Brain Research, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression focused on measuring neurofeedback, real-time fMRI, rumination

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Good general health
  • DSM-5 diagnosis of major depressive disorder (MDD)

Exclusion Criteria:

General Exclusion Criteria:

  • Pregnancy

Medical Conditions:

  • Moderate to severe traumatic brain injury (>30 min. loss of consciousness or >24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits.
  • Presence of co-morbid medical conditions not limited to but including cardiovascular (e.g., history of acute coronary event, stroke) and neurological diseases (e.g., Parkinson's disease), as well as pain disorders.
  • Presence of an uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or to put the study participant at undue risk.

Psychiatric Disorders:

  • Current severe suicidal ideation or attempt within the past 12 months.
  • Psychosis
  • Bipolar disorder
  • Substance abuse or dependence within the previous 6 months

Contraindications for MRI:

  • Bodily implants of unsafe paramagnetic materials such as pace-makers and aneurysm clips.
  • Claustrophobia that is severe enough to preclude MRI scanning.

Medications:

  • Evidence of recreational drug use from a urine test.

Sites / Locations

  • Laureate Institute for Brain Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active neurofeedback

Sham neurofeedback

Arm Description

Receiving feedback signals from the rumination-related brain functional connectivity.

Receiving artificially generated feedback signals.

Outcomes

Primary Outcome Measures

Functional connectivity change between precuneus and right temporoparietal junction (rTPJ)
Functional connectivity between precuneus and rTPJ will be calculated and evaluated using fMRI BOLD percent signal change.
Changes in Brooding subscale of Ruminative Responses Scale (RRS) scores
The RRS Brooding subscale is a self-report scale to measure brooding ruminative responses. A higher score indicates higher brooding ruminative responses with a maximum score of 20 and a minimum score of 5.

Secondary Outcome Measures

Changes in Depression subscale of Ruminative Responses Scale (RRS) scores
The RRS Depression subscale is a self-report scale to measure depressive ruminative responses. A higher score indicates higher ruminative responses with a maximum score of 48 and a minimum score of 12.
Changes in Reflection subscale of Ruminative Responses Scale (RRS) scores
The RRS Reflection subscale is a self-report scale to measure reflective ruminative responses. A higher score indicates higher ruminative responses with a maximum score of 20 and a minimum score of 5.
Changes in sum of Brooding and Depression subscales of Ruminative Responses Scale (RRS) scores
The RRS Brooding and Depression subscales are a self-report scale to measure brooding and depressive ruminative responses. A higher score indicates higher ruminative responses with a maximum score of 68 and a minimum score of 17.
Changes in total score of Ruminative Responses Scale (RRS) scores
The RRS is a self-report scale to measure ruminative responses. A higher score indicates higher ruminative responses with a maximum score of 88 and a minimum score of 22.

Full Information

First Posted
June 10, 2021
Last Updated
January 16, 2023
Sponsor
Laureate Institute for Brain Research, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04941066
Brief Title
Cognitive Process-based Real-time fMRI Neurofeedback in MDD and Rumination
Acronym
CNF-rumination
Official Title
Cognitive Process-based Real-time fMRI Neurofeedback in MDD and Rumination
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laureate Institute for Brain Research, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the feasibility and efficacy of real-time fMRI neurofeedback for rumination.
Detailed Description
Neuroimaging MRI techniques for measuring brain structure, tissue composition, and Blood Oxygenation Level Dependent functional Magnetic Resonance imaging (BOLD fMRI) will be used to measure task-dependent and task-independent brain hemodynamic and electrophysiological changes in human subjects with major depressive disorders (MDD). After being informed about the study and potential risks, all participants giving written informed consent will undergo one session of the cognitive process-based fMRI neurofeedback (CNF) targeting the rumination-related brain functional connectivity, and a one-week follow-up. Participants will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Active (receiving feedback from their own brain activity) or Sham (receiving artificially generated feedback).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
neurofeedback, real-time fMRI, rumination

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to a cognitive process-based real-time fMRI neurofeedback (CNF) or a sham condition.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active neurofeedback
Arm Type
Experimental
Arm Description
Receiving feedback signals from the rumination-related brain functional connectivity.
Arm Title
Sham neurofeedback
Arm Type
Sham Comparator
Arm Description
Receiving artificially generated feedback signals.
Intervention Type
Behavioral
Intervention Name(s)
Active neurofeedback
Intervention Description
The session will be done on an individual basis. The active group will receive neurofeedback training from the rumination-related brain functional connectivity.
Intervention Type
Behavioral
Intervention Name(s)
Sham neurofeedback
Intervention Description
The session will be done on an individual basis. The sham group will receive neurofeedback training from an artificially generated random feedback signal.
Primary Outcome Measure Information:
Title
Functional connectivity change between precuneus and right temporoparietal junction (rTPJ)
Description
Functional connectivity between precuneus and rTPJ will be calculated and evaluated using fMRI BOLD percent signal change.
Time Frame
Through study completion (average: 2 weeks)
Title
Changes in Brooding subscale of Ruminative Responses Scale (RRS) scores
Description
The RRS Brooding subscale is a self-report scale to measure brooding ruminative responses. A higher score indicates higher brooding ruminative responses with a maximum score of 20 and a minimum score of 5.
Time Frame
Through study completion (average: 2 weeks)
Secondary Outcome Measure Information:
Title
Changes in Depression subscale of Ruminative Responses Scale (RRS) scores
Description
The RRS Depression subscale is a self-report scale to measure depressive ruminative responses. A higher score indicates higher ruminative responses with a maximum score of 48 and a minimum score of 12.
Time Frame
Through study completion (average: 2 weeks)
Title
Changes in Reflection subscale of Ruminative Responses Scale (RRS) scores
Description
The RRS Reflection subscale is a self-report scale to measure reflective ruminative responses. A higher score indicates higher ruminative responses with a maximum score of 20 and a minimum score of 5.
Time Frame
Through study completion (average: 2 weeks)
Title
Changes in sum of Brooding and Depression subscales of Ruminative Responses Scale (RRS) scores
Description
The RRS Brooding and Depression subscales are a self-report scale to measure brooding and depressive ruminative responses. A higher score indicates higher ruminative responses with a maximum score of 68 and a minimum score of 17.
Time Frame
Through study completion (average: 2 weeks)
Title
Changes in total score of Ruminative Responses Scale (RRS) scores
Description
The RRS is a self-report scale to measure ruminative responses. A higher score indicates higher ruminative responses with a maximum score of 88 and a minimum score of 22.
Time Frame
Through study completion (average: 2 weeks)
Other Pre-specified Outcome Measures:
Title
Changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores
Description
The MADRS is an interviewer-rated scale to measure the severity of depressive symptoms. A higher score indicates severer depression with a maximum score of 60 and a minimum score of 0.
Time Frame
Through study completion (average: 2 weeks)
Title
Changes in Hamilton Anxiety Rating Scale (HAM-A) scores
Description
The HAMA is an interviewer-rated scale to measure the severity of anxiety symptoms. A higher score indicates severer anxiety with a maximum score of 56 and a minimum score of 0.
Time Frame
Through study completion (average: 2 weeks)
Title
Changes in Patient Health Questionnaire (PHQ-9) scores
Description
The PHQ-9 is a self-report scale to measure depressive symptoms. A higher score indicates severer depressive symptoms with a maximum score of 27 and a minimum score of 0.
Time Frame
Through study completion (average: 2 weeks)
Title
Changes in State-trait Anxiety Inventory (STAI) scores
Description
The STAI is a self-report scale to measure anxiety symptoms. The higher score indicates the higher anxiety with a maximum score of 80 and a minimum score of 20.
Time Frame
Through study completion (average: 2 weeks)
Title
Changes in Metacognitions Questionnaire (MCQ-30) scores
Description
The MCQ-30 is a self-report scale to assess individual differences in five factors important in the metacognitive model of psychological disorders. The five subscales of the MCQ-30 are: cognitive confidence, positive beliefs about worry, cognitive self-consciousness, negative beliefs about uncontrollability of thoughts and danger, and beliefs about the need to control thoughts. The higher scores indicating higher levels of unhelpful metacognitions with a maximum total score of 120 and a minimum score of 30.
Time Frame
Through study completion (average: 2 weeks)
Title
Changes in Thought Control Questionnaire (TCQ) scores
Description
The TCQ is a self-report scale to assess the effectiveness of strategies used for the control of unpleasant and unwanted thoughts. The TCQ measures five factors that correspond to different strategies for controlling unwanted thoughts: Distraction; Social Control; Worry; Punishment; and Re-appraisal. The higher scores indicating the effectiveness of strategies for controlling unwanted thoughts with a maximum total score of 120 and a minimum score of 30.
Time Frame
Through study completion (average: 2 weeks)
Title
Changes in Rosenberg Self-Esteem Scale (RSE) scores
Description
The RSE is a self-report scale to assess global self-worth by measuring both positive and negative feelings about the self. A higher score indicates a higher self-esteem with a maximum score of 30 and a minimum score of 0.
Time Frame
Through study completion (average: 2 weeks)
Title
Changes in Temporal Experience Of Pleasure Scale (TEPS) scores
Description
The TEPS is a self-report scale to assess pleasure experience. Anticipatory abstract pleasure reflected the pleasure experienced in anticipation of something more abstract or broad in nature. Consummatory abstract pleasure was related to consummation of emotional experience of something that is more abstract in nature. A lower score indicates a higher anhedonia propensity with a maximum total score of 120 and a minimum score of 25.
Time Frame
Through study completion (average: 2 weeks)
Title
Changes in Emotion Regulation Questionnaire (ERQ) scores
Description
The ERQ is a self-report scale to assess how they regulate their emotions. The ERQ measures two emotion regulation strategies: Cognitive reappraisal and Expressive suppression. The higher indicates the greater the use of that particular emotion regulation strategy with a maximum total score of 70 and a minimum score of 10.
Time Frame
Through study completion (average: 2 weeks)
Title
Changes in Positive And Negative Affect Schedule Extended (PANAS-X) scores
Description
The PANAS-X is a self-report scale to assess emotional states. The PANAS-X measures 11 specific affects: Fear, Sadness, Guilt, Hostility, Shyness, Fatigue, Surprise, Joviality, Self-Assurance, Attentiveness, and Serenity. Scores on Joviality could range from 8 to 40, with high scores indicating high happiness. Scores on Fear/Hostility/Guilt/Self-Assurance could range from 6 to 30, with high scores indicating high fear/hostility/guilt/self-assurance. Scores on Sadness could range from 5 to 25, with high scores indicating high happiness/sadness. Scores on Attentiveness/Shyness/Fatigue could range from 4 to 20, with high scores indicating high attentiveness/shyness/fatigue. Scores on Serenity/Surprise could range from 3 to 15, with high scores indicating high serenity/surprise.
Time Frame
Through study completion (average: 2 weeks)
Title
Credibility Expectancy Questionnaire (CEQ) score
Description
The CEQ is the most widely used measure of treatment credibility and expectancy in psychotherapy research. The CEQ will be administered after the full introduction of the intervention rationale and principles and after the experience of the intervention. The items are rated on 9-point scales ranging from 1 (Not at all logical/useful/confident) to 9 (Very logical/useful/confident), with a total score possible range of 6 to 54. A higher score indicates higher treatment credibility and expectancy.
Time Frame
Through study completion (average: 2 weeks)
Title
Post Neurofeedback Questionnaire score
Description
This is a study original questionnaire assessing the blindness and pleasantness. The blindness item is rated from 0 to 10, with a possible range of 0 to 10. The lower score indicates the confidence of the blindness. The pleasantness item is rated from 0 to 10 , with a possible range of 0 to 10. A higher score indicates the pleasantness of the intervention. The challenging/difficulties items are rated from 0 to 10, with a possible total range of 0 to 20. A higher score indicates the challenges/difficulties of the intervention. The two successful items are rated from 0 to 10, with a possible range of 0 to 20. A higher score indicates the subjective evaluation of the success of the intervention. The four mental strategies items are rated from 0 to 10, with a possible range of 0 to 40. A higher score indicates the mental strategies used in the intervention were helpful.
Time Frame
Through study completion (average: 2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Good general health DSM-5 diagnosis of major depressive disorder (MDD) Exclusion Criteria: General Exclusion Criteria: Pregnancy Medical Conditions: Moderate to severe traumatic brain injury (>30 min. loss of consciousness or >24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits. Presence of co-morbid medical conditions not limited to but including cardiovascular (e.g., history of acute coronary event, stroke) and neurological diseases (e.g., Parkinson's disease), as well as pain disorders. Presence of an uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or to put the study participant at undue risk. Psychiatric Disorders: Current severe suicidal ideation or attempt within the past 12 months. Psychosis Bipolar disorder Substance abuse or dependence within the previous 6 months Contraindications for MRI: Bodily implants of unsafe paramagnetic materials such as pace-makers and aneurysm clips. Claustrophobia that is severe enough to preclude MRI scanning. Medications: Evidence of recreational drug use from a urine test.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvador Guinjoan, MD, PhD
Organizational Affiliation
Laureate Institute for Brain Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laureate Institute for Brain Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cognitive Process-based Real-time fMRI Neurofeedback in MDD and Rumination

We'll reach out to this number within 24 hrs