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
About this trial
This is an interventional basic science trial for Depression
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
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
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
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Effects of Attention Training Interventions on Depression
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