Depressive SymptomsNCT03869463
Computerized Cognitive Training in Young Adults With Depression
A study testing Computerized Cognitive Training in people with Depressive Symptoms, run by Queens College, The City University of New York at 1 site in United States.
Trial summary
The purpose of the study is to examine the benefits and mechanism of action of computerized cognitive training (CCT) on mood, neuropsychological deficits, everyday functioning, and brain activity among young adults with a range of depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Computerized Cognitive Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2019to 31 Mar 2023
- 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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-29.
- Current diagnosis of MDD/persistent depressive disorder or HDRS greater than or equal to 12. 3. Daily access to smartphone or tablet with internet connection for the study duration.
- 4. Willing and able to complete MRI, mood, and neuropsychological testing. 5. IQ > 85.
Who cannot join
- Lacks English-speaking ability as determined by self-report and clinical evaluation.
- Evidence of schizophrenia, schizoaffective disorder, psychosis, bipolar I and II disorder.
- Active suicidal ideation, intent, or plan, or past attempt within 1 year.
- Severe depression (HDRS > 30).
- Neurological disorder (epilepsy, multiple sclerosis, traumatic brain injury, clinical stroke).
- Use of medications known to have negative impact on cognition (benzodiazepines and lorazepam equivalents > 1mg daily, narcotics, anticholinergics).
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- History of alcohol or drug abuse or dependence within past year.
- Acute, severe, unstable medical illness. For cancer, acutely ill patients (including those with metastases) are excluded, but past history of successfully treated cancer does not result in exclusion.
- Regular online brain training or regular player of non-fluency verbal games, defined as doing these procedures at a frequency of twice weekly or greater during the year prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Mechanism of Action of Computerized Cognitive Training in Young Adults With Depression: Clinical, Cognitive and Neuroimaging Outcomes
The purpose of the study is to examine the benefits and mechanism of action of computerized cognitive training (CCT) on mood, neuropsychological deficits, everyday functioning, and brain activity among young adults with a range of depressive symptoms.
- Conditions
- Depressive Symptoms
- Being tested
- Computerized Cognitive Training, Control
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive TrainingOther
Participants will complete 8 weeks of computerized cognitive training through the Peak platform on mobile devices.
ControlOther
This group will not receive computerized cognitive training.
| Study group | Role | What they receive |
|---|---|---|
| EF/PS CCT | Experimental | This group will complete EF/PS (executive functioning/processing speed) computerized cognitive training (CCT) which includes games specifically focused on executive function \& processing speed. Receives: Other: Computerized Cognitive Training |
| Verbal CCT | Active comparator | This group will complete verbal-focused computerized cognitive training. Receives: Other: Computerized Cognitive Training |
| Waitlist Control | Placebo comparator | This group will not receive cognitive training during study participation. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sheehan Disability Scale
Self-report questionnaire of everyday functioning. It includes three subscales: work, social life, leisure activities, and home life or family responsibilities. Each subscale is rated on a 10-point scale for a minimum total score of 0 and a maximum total summed score of 30 across the three subscales. High scores are associated with more impairment.
Measured: Screen, Week 0, Week 4, Week 8, 3-month follow-up
Change in Hamilton Depression Rating Scale
Clinician-rated measure of depression composed of 21 questions. The first 17 items are scored: eight items have a 5-point scale, nine items have a 3-point scale. Total score range is 0-52. Higher scores indicate more severe symptoms.
Measured: Screen, Week 0, Week 4, Week 8, 3-month follow-up
Change in DKEFS Trail Making Test - Condition 4
Measure of executive function. It is a switching task that requires the subject to connect numbers and letters in an alternating pattern (1-A-2-B, etc.) as quickly as possible.
Measured: Weeks 0, 4, 8, 3-month follow- up
Change in Emotional Go/No Go Task (fMRI)
Measure of behavioral inhibition and set shifting. Participants must press a button for pre-specified to go trials and withhold pressing the button for pre-specified no-go trials.
Measured: Week 0, Week 4 or Week 8 (depending on randomization)
Secondary outcomes (3)
Change in Beck Depression Inventory-II
Self-report questionnaire of depression composed of 21 questions on a 4-point scale. Total score ranges from 0-63. Higher scores indicate worse symptom severity.
Measured: Screen, weekly for weeks 0-8, 3-month follow-up
Change in WAIS-IV Coding
Participants are required to copy symbols paired with numbers in a 120 second time limit. The score is the number correct in the allotted time.
Measured: Weeks 0, 4, 8, 3-month follow- up
Change in Connectivity Index (resting state fMRI)
Measure of resting state fMRI. Higher scores indicate more connectivity within the network
Measured: Week 0, Week 4 or Week 8 (depending on randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start11 Oct 2019
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Why it stopped: Challenges to recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queens College, The City University of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel R Sneed, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869463
- Sponsor's protocol ID
- 2018-1311
- Status last verified
- Sep 2022
- First submitted
- 7 Feb 2019
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rushia SN, Schiff S, Egglefield DA, Motter JN, Grinberg A, Saldana DG, Shehab AAS, Fan J, Sneed JR. Testing the Mechanism of Action of Computerized Cognitive Training in Young Adults with Depression: Protocol for a Blinded, Randomized, Controlled Treatment Trial. J Psychiatr Brain Sci. 2020;5:e200014. doi: 10.20900/jpbs.20200014. Epub 2020 Jun 19.
PubMed 32743079
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Mechanism of Action of Computerized Cognitive Training in Young Adults With Depression: Clinical, Cognitive and Neuroimaging Outcomes
- ClinicalTrials.gov ID
- NCT03869463
- Acronym / sponsor ID
- 2018-1311
- Conditions
- Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Challenges to recruitment
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Queens College, The City University of New YorkUniversity, hospital or other
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 11 Mar 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 the study is to examine the benefits and mechanism of action of computerized cognitive training (CCT) on mood, neuropsychological deficits, everyday functioning, and brain activity among young adults with a range of depressive symptoms.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EF/PS CCT | Experimental | Other: Computerized Cognitive TrainingThis group will complete EF/PS (executive functioning/processing speed) computerized cognitive training (CCT) which includes games specifically focused on executive function \& processing speed. |
| Verbal CCT | Active comparator | Other: Computerized Cognitive TrainingThis group will complete verbal-focused computerized cognitive training. |
| Waitlist Control | Placebo comparator | Other: ControlThis group will not receive cognitive training during study participation. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-29.
- Current diagnosis of MDD/persistent depressive disorder or HDRS greater than or equal to 12. 3. Daily access to smartphone or tablet with internet connection for the study duration.
- 4. Willing and able to complete MRI, mood, and neuropsychological testing. 5. IQ > 85.
Key exclusion criteria (9 listed)
- Lacks English-speaking ability as determined by self-report and clinical evaluation.
- Evidence of schizophrenia, schizoaffective disorder, psychosis, bipolar I and II disorder.
- Active suicidal ideation, intent, or plan, or past attempt within 1 year.
- Severe depression (HDRS > 30).
- Neurological disorder (epilepsy, multiple sclerosis, traumatic brain injury, clinical stroke).
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 |
|---|---|---|
| Computerized Cognitive TrainingParticipants will complete 8 weeks of computerized cognitive training through the Peak platform on mobile devices. | Other | EF/PS CCT, Verbal CCT |
| ControlThis group will not receive computerized cognitive training. | Other | Waitlist Control |
Primary outcome
Change in Sheehan Disability Scale
Time frame: Screen, Week 0, Week 4, Week 8, 3-month follow-up
Self-report questionnaire of everyday functioning. It includes three subscales: work, social life, leisure activities, and home life or family responsibilities. Each subscale is rated on a 10-point scale for a minimum total score of 0 and a maximum total summed score of 30 across the three subscales. High scores are associated with more impairment.
Change in Hamilton Depression Rating Scale
Time frame: Screen, Week 0, Week 4, Week 8, 3-month follow-up
Clinician-rated measure of depression composed of 21 questions. The first 17 items are scored: eight items have a 5-point scale, nine items have a 3-point scale. Total score range is 0-52. Higher scores indicate more severe symptoms.
Change in DKEFS Trail Making Test - Condition 4
Time frame: Weeks 0, 4, 8, 3-month follow- up
Measure of executive function. It is a switching task that requires the subject to connect numbers and letters in an alternating pattern (1-A-2-B, etc.) as quickly as possible.
Change in Emotional Go/No Go Task (fMRI)
Time frame: Week 0, Week 4 or Week 8 (depending on randomization)
Measure of behavioral inhibition and set shifting. Participants must press a button for pre-specified to go trials and withhold pressing the button for pre-specified no-go trials.
3 secondary outcomes
Change in Beck Depression Inventory-II
Time frame: Screen, weekly for weeks 0-8, 3-month follow-up
Change in WAIS-IV Coding
Time frame: Weeks 0, 4, 8, 3-month follow- up
Change in Connectivity Index (resting state fMRI)
Time frame: Week 0, Week 4 or Week 8 (depending on randomization)
Results and safety
The study was stopped early (reason given: Challenges to recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Derived from this study: PubMed 32743079Rushia SN, Schiff S, Egglefield DA, Motter JN, Grinberg A, Saldana DG, Shehab AAS, Fan J, Sneed JR. Testing the Mechanism of Action of Computerized Cognitive Training in Young Adults with Depression: Protocol for a Blinded, Randomized, Controlled Treatment Trial. J Psychiatr Brain Sci. 2020;5:e200014. doi: 10.20900/jpbs.20200014. Epub 2020 Jun 19.
- 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.
Joel R Sneed, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Cognitive Training in people with Depressive Symptoms, run by Queens College, The City University of New York 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 3 inclusion and 9 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 25 Sep 2023. 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. Some participants in this study may receive a placebo. 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: Challenges to recruitment). 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?
Change in Sheehan Disability Scale (time frame: Screen, Week 0, Week 4, Week 8, 3-month follow-up). 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?
On the ClinicalTrials.gov record for NCT03869463, which also lists 1 linked publication.
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 25 Sep 2023.