Effects of Attention Training Interventions on Depression

• Sponsor: Mclean Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04184206
• Collaborator: (none)
• Enrollment: 165
• Arms: 3
• Anticipated Duration (Months): 48

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression; Attention Training; Symptoms, Cognitive; Symptoms, Affective; Symptoms, Behavioral	Behavioral: attention training intervention 1; Behavioral: attention training intervention 2; Behavioral: attention training intervention 3	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 165 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effects of Attention Training Interventions on Depression
• Anticipated Study Start Date: Apr 1, 2020
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: attention training intervention 1 14-day smartphone-based audio-guided attention training program with heavy mindfulness influence	Behavioral: attention training intervention 1; 14-day smartphone-based audio-guided attention training program with heavy mindfulness component
Active Comparator: attention training intervention 2 14-day smartphone-based audio-guided attention training program with moderate mindfulness influence	Behavioral: attention training intervention 2; 14-day smartphone-based audio-guided attention training program with moderate mindfulness component
Active Comparator: attention training intervention 3 14-day smartphone-based audio-guided intervention without mindfulness emphasis	Behavioral: attention training intervention 3; 14-day smartphone-based audio-guided attention training program without mindfulness component

Outcome Measures

Primary Outcome Measures

1. 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) [pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)]

2. changes in neural measures including "functional connectivity" functional magnetic resonance imaging (fMRI) collected during rest conditions [pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)]

3. changes in behavioral task performance including related to affective (e.g., Probabilistic Reward Task [PRT]) [pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)]

4. changes in behavioral task performance including related to cognitive processing (e.g., Flanker Task). [pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Mclean Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matthew Sacchet, Assistant Neuroscientist, Mclean Hospital
• ClinicalTrials.gov Identifier: NCT04184206
• Other Study ID Numbers: McLean
• First Posted: Dec 3, 2019
• Last Update Posted: Feb 19, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neurobehavioral Manifestations; Depression; Depressive Disorder; Behavioral Symptoms; Affective Symptoms

Study Results

No Results Posted as of Feb 19, 2020