Effects of Attention Training Interventions on Depression

Not Applicable

Terminated

• Conditions: Depression; Attention Training; Symptoms, Cognitive; Symptoms, Affective; Symptoms, Behavioral
• Interventions: Behavioral: attention training intervention 3; Behavioral: attention training intervention 2; Behavioral: attention training intervention 1

• Registration Number: NCT04184206
• Lead Sponsor: Mclean Hospital

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.

Study Timeline

• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-03
• Study Start: 2021-08-31
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-16
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
attention training intervention 3	attention training intervention 3	14-day smartphone-based audio-guided intervention without mindfulness emphasis
attention training intervention 2	attention training intervention 2	14-day smartphone-based audio-guided attention training program with moderate mindfulness influence
attention training intervention 1	attention training intervention 1	14-day smartphone-based audio-guided attention training program with heavy mindfulness influence

Primary Outcome Measures

Name	Time	Method
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 cognitive processing (e.g., Flanker Task).	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 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)

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States