DepressionNCT04184206
Effects of Attention Training Interventions on Depression
A study testing attention training intervention 1, attention training intervention 2 and attention training intervention 3 in people with Depression and Attention Training, run by Mclean Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Depression, Attention Training, Symptoms, Cognitive
- What is being tested?
- attention training intervention 1, attention training intervention 2 and attention training intervention 3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Normal or corrected-to-normal vision and hearing
- Fluency in written and spoken English
- Absence of psychotropic medication
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to study the effects of attention training interventions on symptoms and brain function in major depressive disorder.
Read the 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.
- Conditions
- Depression, Attention Training, Symptoms, Cognitive, Symptoms, Affective, Symptoms, Behavioral
- Being tested
- attention training intervention 1, attention training intervention 2, attention training intervention 3
- Medical subject headings
- Depression, Neurobehavioral Manifestations, Affective Symptoms, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
attention training intervention 1Behavioural
14-day smartphone-based audio-guided attention training program with heavy mindfulness component
attention training intervention 2Behavioural
14-day smartphone-based audio-guided attention training program with moderate mindfulness component
attention training intervention 3Behavioural
14-day smartphone-based audio-guided attention training program without mindfulness component
| Study group | Role | What they receive |
|---|---|---|
| attention training intervention 1 | Active comparator | 14-day smartphone-based audio-guided attention training program with heavy mindfulness influence Receives: Behavioral: attention training intervention 1 |
| attention training intervention 2 | Active comparator | 14-day smartphone-based audio-guided attention training program with moderate mindfulness influence Receives: Behavioral: attention training intervention 2 |
| attention training intervention 3 | Active comparator | 14-day smartphone-based audio-guided intervention without mindfulness emphasis Receives: Behavioral: attention training intervention 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 conditions
Measured: 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])
Measured: 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).
Measured: pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start31 Aug 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Why it stopped: Moved institutions, study terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Sacchet, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184206
- Sponsor's protocol ID
- McLean
- Status last verified
- Mar 2024
- First submitted
- 4 Apr 2019
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Attention Training Interventions on Depression
- ClinicalTrials.gov ID
- NCT04184206
- Acronym / sponsor ID
- McLean
- Conditions
- Depression, Attention Training, Symptoms, Cognitive, Symptoms, Affective, Symptoms, Behavioral
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Moved institutions, study terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| attention training intervention 1 | Active comparator | Behavioral: attention training intervention 114-day smartphone-based audio-guided attention training program with heavy mindfulness influence |
| attention training intervention 2 | Active comparator | Behavioral: attention training intervention 214-day smartphone-based audio-guided attention training program with moderate mindfulness influence |
| attention training intervention 3 | Active comparator | Behavioral: attention training intervention 314-day smartphone-based audio-guided intervention without mindfulness emphasis |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- DSM-5 criteria for major depressive disorder
- Written informed consent
- Both biological sexes, any ethnicity
- Age 18-55
- Scores exceeding cutoffs on depression questionnaires
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| attention training intervention 114-day smartphone-based audio-guided attention training program with heavy mindfulness component | Behavioural | attention training intervention 1 |
| attention training intervention 214-day smartphone-based audio-guided attention training program with moderate mindfulness component | Behavioural | attention training intervention 2 |
| attention training intervention 314-day smartphone-based audio-guided attention training program without mindfulness component | Behavioural | attention training intervention 3 |
Primary outcome
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)
Time frame: 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 conditions
Time frame: 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])
Time frame: 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).
Time frame: pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)
Results and safety
The study was stopped early (reason given: Moved institutions, study terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing attention training intervention 1, attention training intervention 2 and attention training intervention 3 in people with Depression and Attention Training, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Moved institutions, study terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: pre-treatment to post-treatment (approximately 3-4 weeks from intervention start date)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024; AzTrials last refreshed its copy on 2 Nov 2026.