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Effects of Attention Training Interventions on Depression

Primary Purpose

Depression, Attention Training, Symptoms, Cognitive

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

attention training intervention 1

attention training intervention 2

attention training intervention 3

About this trial

This is an interventional basic science trial for Depression

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria include:

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 include:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

attention training intervention 1

attention training intervention 2

attention training intervention 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

changes in questionnaire measures including severity of depression (e.g., Beck Depression Inventory [BDI-II]: minimum/maximum values = 0/63, higher scores indicate worse outcome)

changes in neural measures including "functional connectivity" functional magnetic resonance imaging (fMRI) collected during rest conditions

changes in behavioral task performance including related to affective (e.g., Probabilistic Reward Task [PRT])

changes in behavioral task performance including related to cognitive processing (e.g., Flanker Task).

Secondary Outcome Measures

Full Information

NCT ID

NCT04184206

First Posted

April 4, 2019

Last Updated

February 18, 2020

Sponsor

Mclean Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04184206

Brief Title

Effects of Attention Training Interventions on Depression

Official Title

Effects of Attention Training Interventions on Depression

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 2020 (Anticipated)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mclean Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

attention training intervention 1

Arm Type

Active Comparator

Arm Description

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

Arm Title

attention training intervention 2

Arm Type

Active Comparator

Arm Description

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

Arm Title

attention training intervention 3

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

attention training intervention 1

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

attention training intervention 2

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

attention training intervention 3

Intervention Description

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

Primary Outcome Measure Information:

Title

changes in questionnaire measures including severity of depression (e.g., Beck Depression Inventory [BDI-II]: minimum/maximum values = 0/63, higher scores indicate worse outcome)

Time Frame

pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)

Title

changes in neural measures including "functional connectivity" functional magnetic resonance imaging (fMRI) collected during rest conditions

Time Frame

pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)

Title

changes in behavioral task performance including related to affective (e.g., Probabilistic Reward Task [PRT])

Time Frame

pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)

Title

changes in behavioral task performance including related to cognitive processing (e.g., Flanker Task).

Time Frame

pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria include: 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 include: 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

12. IPD Sharing Statement

Plan to Share IPD

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Effects of Attention Training Interventions on Depression

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