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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
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

    Active Comparator

    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

    First Posted
    April 4, 2019
    Last Updated
    February 18, 2020
    Sponsor
    Mclean Hospital
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    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
    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 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
    No
    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
    No

    Learn more about this trial

    Effects of Attention Training Interventions on Depression

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