Effects of Attention Training Interventions on Depression

Depression Clinical Trial

Official title:

Effects of Attention Training Interventions on Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04184206
• Other study ID #: McLean
• Status: Terminated
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: March 2024
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Affective Symptoms
• Attention Training
• Behavioral Symptoms
• Depression
• Depressive Disorder
• Neurobehavioral Manifestations
• Symptoms, Affective
• Symptoms, Behavioral
• Symptoms, Cognitive

Intervention

Behavioral:
• attention training intervention 1
14-day smartphone-based audio-guided attention training program with heavy mindfulness component
• attention training intervention 2
14-day smartphone-based audio-guided attention training program with moderate mindfulness component
• attention training intervention 3
14-day smartphone-based audio-guided attention training program without mindfulness component

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)