Effects of Attention Training Interventions on Depression

NCT ID: NCT04184206

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2022-04-30

Brief Summary

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The purpose of this study is to study the effects of attention training interventions on symptoms and brain function in major depressive disorder.

Detailed Description

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Attention training programs including mindfulness meditation-based interventions have been shown to be effective for treating depression. Currently the biological and psychological mechanisms of action of attention training for major depression disorder are unknown. The objective of the current study is to improve the investigator's understanding of the mechanisms of attention training interventions for depression.

Research participants will include approximately 165 individuals with major depressive disorder randomized to one of three types of attention training programs. Before and after intervention participants will complete a number of biological assessments including MRI, EEG, behavioral tasks, and questionnaires. The study will be completed across three visits: (1) a screening visit; (2) data collection session 1; and (3) data collection session 2.

Conditions

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Depression Attention Training Symptoms, Cognitive Symptoms, Affective Symptoms, Behavioral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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attention training intervention 1

14-day smartphone-based audio-guided attention training program with heavy mindfulness influence

Group Type ACTIVE_COMPARATOR

attention training intervention 1

Intervention Type BEHAVIORAL

14-day smartphone-based audio-guided attention training program with heavy mindfulness component

attention training intervention 2

14-day smartphone-based audio-guided attention training program with moderate mindfulness influence

Group Type ACTIVE_COMPARATOR

attention training intervention 2

Intervention Type BEHAVIORAL

14-day smartphone-based audio-guided attention training program with moderate mindfulness component

attention training intervention 3

14-day smartphone-based audio-guided intervention without mindfulness emphasis

Group Type ACTIVE_COMPARATOR

attention training intervention 3

Intervention Type BEHAVIORAL

14-day smartphone-based audio-guided attention training program without mindfulness component

Interventions

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attention training intervention 1

14-day smartphone-based audio-guided attention training program with heavy mindfulness component

Intervention Type BEHAVIORAL

attention training intervention 2

14-day smartphone-based audio-guided attention training program with moderate mindfulness component

Intervention Type BEHAVIORAL

attention training intervention 3

14-day smartphone-based audio-guided attention training program without mindfulness component

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* DSM-5 criteria for major depressive disorder
* Written informed consent
* Both biological sexes, any ethnicity
* Age 18-55
* Scores exceeding cutoffs on depression questionnaires
* Right-handed
* Normal or corrected-to-normal vision and hearing
* Fluency in written and spoken English
* Absence of psychotropic medication

Exclusion Criteria

* Use of substances or prior treatments that may interfere with study procedures or outcomes (e.g., stimulants, blood pressure medication)
* Medical conditions that may interfere with study procedures or outcomes (e.g., thyroid disorder)
* Current therapy and practices overlapping with study interventions
* Select other DSM-5 disorders and symptoms (e.g., psychotic symptoms, suicidal ideation)
* Failure to meet MRI safety requirements or suitability
* Significant inconsistencies in self-report or first-degree relatives with history or current psychotic symptoms
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mclean Hospital

OTHER

Sponsor Role lead

Responsible Party

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Matthew Sacchet

Assistant Neuroscientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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McLean Hospital

Belmont, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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McLean

Identifier Type: -

Identifier Source: org_study_id

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