Effects of Attention Training Interventions on Depression

Mass General Brigham

Status: Terminated

Conditions: Symptoms, Affective; Symptoms, Behavioral; Depression; Attention Training; Symptoms, Cognitive

Treatments: Behavioral: attention training intervention 3; Behavioral: attention training intervention 1; Behavioral: attention training intervention 2

Study type: Interventional

Funder types: Other

Identifiers

NCT04184206

McLean

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

3 participants in 3 patient groups

attention training intervention 1

Active Comparator group

Description:

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

Treatment:

Behavioral: attention training intervention 1

attention training intervention 2

Active Comparator group

Description:

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

Treatment:

Behavioral: attention training intervention 2

attention training intervention 3

Active Comparator group

Description:

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

Treatment:

Behavioral: attention training intervention 3