Effects of Attention Training Interventions on Depression

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

Study Overview

• Status: Terminated
• Conditions: Depression; Attention Training; Symptoms, Cognitive; Symptoms, Affective; Symptoms, Behavioral
• Intervention / Treatment: Behavioral: attention training intervention 1; Behavioral: attention training intervention 2; Behavioral: attention training intervention 3

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Mclean Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Mood Disorders; Neurologic Manifestations; Depression; Depressive Disorder; Neurobehavioral Manifestations; Behavioral Symptoms; Affective Symptoms
• Other Study ID Numbers: McLean

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No