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Effects of Attention Training Interventions on Depression

Effects of Attention Training Interventions on Depression

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04184206
Enrollment
3
Registered
2019-12-03
Start date
2021-08-31
Completion date
2022-04-30
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Training, Depression, Symptoms, Affective, Symptoms, Behavioral, Symptoms, Cognitive

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.

Interventions

BEHAVIORALattention training intervention 1

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

BEHAVIORALattention training intervention 2

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

BEHAVIORALattention training intervention 3

14-day smartphone-based audio-guided attention training program without mindfulness component

Sponsors

Mclean Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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

Design outcomes

Primary

MeasureTime 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 conditionspre-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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026