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

Depression Clinical Trial

— CNF-rumination  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04941066
• Other study ID #: 2021-002
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: January 2023
• Source: Laureate Institute for Brain Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the feasibility and efficacy of real-time fMRI neurofeedback for rumination.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

Behavioral:
• Active neurofeedback
The session will be done on an individual basis. The active group will receive neurofeedback training from the rumination-related brain functional connectivity.
• Sham neurofeedback
The session will be done on an individual basis. The sham group will receive neurofeedback training from an artificially generated random feedback signal.

Locations

Country	Name	City	State
United States	Laureate Institute for Brain Research	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Laureate Institute for Brain Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores	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.	Through study completion (average: 2 weeks)
Other	Changes in Hamilton Anxiety Rating Scale (HAM-A) scores	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.	Through study completion (average: 2 weeks)
Other	Changes in Patient Health Questionnaire (PHQ-9) scores	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.	Through study completion (average: 2 weeks)
Other	Changes in State-trait Anxiety Inventory (STAI) scores	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.	Through study completion (average: 2 weeks)
Other	Changes in Metacognitions Questionnaire (MCQ-30) scores	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.	Through study completion (average: 2 weeks)
Other	Changes in Thought Control Questionnaire (TCQ) scores	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.	Through study completion (average: 2 weeks)
Other	Changes in Rosenberg Self-Esteem Scale (RSE) scores	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.	Through study completion (average: 2 weeks)
Other	Changes in Temporal Experience Of Pleasure Scale (TEPS) scores	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.	Through study completion (average: 2 weeks)
Other	Changes in Emotion Regulation Questionnaire (ERQ) scores	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.	Through study completion (average: 2 weeks)
Other	Changes in Positive And Negative Affect Schedule Extended (PANAS-X) scores	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.	Through study completion (average: 2 weeks)
Other	Credibility Expectancy Questionnaire (CEQ) score	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.	Through study completion (average: 2 weeks)
Other	Post Neurofeedback Questionnaire score	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.	Through study completion (average: 2 weeks)
Primary	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.	Through study completion (average: 2 weeks)
Primary	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.	Through study completion (average: 2 weeks)
Secondary	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.	Through study completion (average: 2 weeks)
Secondary	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.	Through study completion (average: 2 weeks)
Secondary	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.	Through study completion (average: 2 weeks)
Secondary	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.	Through study completion (average: 2 weeks)