Clinical Trials to Evaluate Neurophysiological and Neuropsychological Effects of a Mindfulness-based Intervention

NCT06618339 | Enrolling By Invitation

• 1 other identifier: 215/2/C/63/24
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Depression and anxiety are conditions with a high prevalence in the world population and youth are no exception. In developing countries it is reported that given the conditions of social disadvantage, anxiety and depression are higher, resulting in compromised psychological well-being and mental health. Therefore, treatments that help in the care and prevention of these disorders from youth are important. In the case of contemporary psychology, Mindfulness treatments have emerged as an alternative treatment for some of the symptoms of depression, anxiety and emotional discomfort, showing evidence of increased improvement in the overall quality of life. The project responds to global mental health demands and will provide the institution, as well as external collaborating institutions and society in general, with guidelines to carry out brief and effective interventions for these problems and will develop clinical evidence and technological tools for their analysis. Objective: To compare the neurophysiological effects by means of EEG signals and machine learning or deep learning techniques and neuropsychological effects of a brief treatment based on mindfulness-based intervention techniques as an alternative intervention for the reduction of anxiety and depression symptoms against the effects of psychoeducation groups and placebo group in young adults. Methodology: Factorial design of cases and controls according to the guidelines for randomized controlled trials CONSORT. Participants (n=125) will be randomized triple-blinded with neuropsychological and neurophysiological assessments. The results of the project will generate basic evidence on the condition of brain functioning at the neurophysiological level, its performance to perform processes of utmost relevance to solve daily life problems and psychological well-being, as well as support the development of techniques for specialists in behavioral analysis and mental health and engineering sciences for the creation and implementation of programs and strategies for the prevention, identification, care and evaluation of mental health and social well-being, with a scientific and community health approach.

Conditions

Anxiety Depression (Mild or Not Persistent)

Keywords

Anxiety; Depression

Outcome Measures

Primary Outcomes (11)

• Neurophysiological measures

  Neurophysiological, electroencephalographic (EEG) recordings will be performed: Each participant will undergo a five minute EEG recording in resting state, previous to any intervention, 128 Hz sampling rate, from 8 ch, EMOTIV Epoc (AF3, AF4, F3, F4, F7, F8, FC5, FC6), with saline solution for conductivity improvement. Offline EEG features frontal alpha-beta proportion change (if any) will be calculated using windowing power spectra transform. Follow-up five minutes, recordings after each intervention session and post-intervention program will be performed as well.

  Pre-post intervention assessment, after 8 weeks. A follow-up measure will be recorded immidiatly after each intervention session, 8 weeks as well.

• Mood measures

  Anxiety and depression index will be calculated from Beck's adapted and validated version to Mexican population. Scores range from 0 min-30 max, normal score ranges from 25-30.

  Pre-post intervention assessment, after 8 weeks.

• Card Sorting Test

  Card Sorting Test, will be measured from the standardized executive function test BANFE, using accurcy of response, perseverations, time, and errors. Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).

  Pre-post intervention assessment, after 8 weeks.

• Self directed signaling

  Self directed signaling, will be measured from the standardized executive function test BANFE, using accuracy of response, time, and errors. Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).

  Pre-post intervention assessment, after 8 weeks.

• Stroop Test

  Stroop test, will be measured from the standardized executive function test BANFE, using accuracy of response, stroop type error, no-Stroop errors, and time, Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).

  Pre-post intervention assessment, after 8 weeks.

• Working memory

  Working Memory will be measured from the standardized executive function test BANFE, using accuracy of response as scoring criteria. Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).

  Pre-post intervention assessment, after 8 weeks.

• Gambling test

  Gambling test, will be measured by calculating EF quotients from the standardized test BANFE using risk cards percentage, final total score. Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).

  Pre-post intervention assessment, after 8 weeks.

• Tower of Hanoi

  Tower of Hanoi, using number of movements, and time, will be measured by calculating EF quotients from the standardized test BANFE. Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).

  Pre-post intervention assessment, after 8 weeks.

• Metamemory

  Metamemory, will be measured by calculating EF quotients from the standardized test BANFE using positive and negative errors. Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).

  Pre-post intervention assessment, after 8 weeks.

• Neuropsychological evaluation

  Attention and Memory, normilized quotient will be calculated according to NEUROPSI standard Attention and Memory Standardized test, using accuracy of response, and time as direct measures of each task. Attention and memory score is normalized according to age and years of education, scores range from 1-19 (1-3 extremely low, 4-6 low, 7-13 normal, 14-19 high performance).

  Pre-post intervention assessment, after 8 weeks.

• Neuropsychological measure

  Social Cognition, according to index from computarized adapted version of the Mind in the Eyes test, index 0 (min) - 36 (max) score, expected score ranges from 25-36.

  Pre-post intervention assessment, after 8 weeks.

Study Arms (2)

Psychoeducation

OTHER

8 session Psychoeducation, for anxiety and depression.

Behavioral: Mindfulness-based intervention

Cognitive flexibility and resilence

SHAM COMPARATOR

8 Session cognitive flexibility and resilience trainning.

Behavioral: Mindfulness-based intervention

Interventions

Mindfulness-based intervention BEHAVIORAL

8 Session Mindfulness-based intervention

Cognitive flexibility and resilence; Psychoeducation

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Young adults 18-30 years old
• University students enrolled in any of the Autonomous University of Baja California programs.
• To properly accomplish to all assessment procedures
• To properly accomplish at least 80% of the intervention sessions
• Interest to voluntarly participate.

You may not qualify if:

• Disgnosis of neurological or psychitric disease, including severe anxiety or depression.
• Incomplete protocol evaluation.
• Out of 18-30 years old range age.
• Being enrolled in a different psychological or psychiatric intervention or treatment program during the period of evaluation and intervention.

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

Study Sites (1)

Universidad Autónoma de Baja California, Neuroscience and Cognition Laboratory

Mexicali, Estado de Baja California, 21720, Mexico

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full time Professor

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: December 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)