Clinical trial NCT04184206: Effects of Attention Training Interventions on Depression
Official title: Effects of Attention Training Interventions on Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Attention Training
Symptoms, Cognitive
Symptoms, Affective
Symptoms, Behavioral
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)
measure: changes in neural measures including "functional connectivity" functional magnetic resonance imaging (fMRI) collected during rest conditions
timeFrame: pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)
measure: changes in behavioral task performance including related to affective (e.g., Probabilistic Reward Task [PRT])
timeFrame: pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)
measure: changes in behavioral task performance including related to cognitive processing (e.g., Flanker Task).
timeFrame: pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
References: