Cognitive-affective ExercisesNCT02075190
Trial of a Nationwide Cognitive-Affective Remediation Training Intervention in Depression
A study testing Therapeutic Computerized intervention and Nontherapeutic computerized intervention in people with Cognitive-affective Exercises and Engaging Exercises, run by Stanford University at 1 site in United States.
Trial summary
The objective is to examine the efficacy of computerized interventions for increasing well-being and cognitive functioning. The study will seek to validate emerging online delivery methods of psychiatric assessment and treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive-affective Exercises, Engaging Exercises
- What is being tested?
- Therapeutic Computerized intervention and Nontherapeutic computerized intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Aug 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- computer and broadband internet access
- 18 years of age
- Elevated anxiety and depression
- Native English speaker
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The objective is to examine the efficacy of computerized interventions for increasing well-being and cognitive functioning. The study will seek to validate emerging online delivery methods of psychiatric assessment and treatment. This will allow us to test the efficacy of this intervention in a larger and more geographically broad sample than is possible through traditional recruitment and treatment, and to do so in a highly cost-effective manner.
- Conditions
- Cognitive-affective Exercises, Engaging Exercises
- Being tested
- Therapeutic Computerized intervention, Nontherapeutic computerized intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Computerized interventionOther
Remediation training intervention
Nontherapeutic computerized interventionOther
Online gaming intervention
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants randomized to receive remediation training intervention delivered online (60 days of online training) Receives: Other: Therapeutic Computerized intervention |
| Control Group | Active comparator | Participants randomized to receive online gaming intervention (60 days of online play) Receives: Other: Nontherapeutic computerized intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Behavioral measure of executive functions
Measured: 1 month
Secondary outcomes (1)
Self-report mood and anxiety symptoms
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Dr. Gyurak is no longer doing and ended her NARSAD early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive-affective ExercisesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Etkin, Stanford University
- Investigators
- Anett Gyurak, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075190
- Sponsor's protocol ID
- 28625
- Status last verified
- Apr 2019
- First submitted
- 27 Feb 2014
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of a Nationwide Cognitive-Affective Remediation Training Intervention in Depression
- ClinicalTrials.gov ID
- NCT02075190
- Acronym / sponsor ID
- 28625
- Conditions
- Cognitive-affective Exercises, Engaging Exercises
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Dr. Gyurak is no longer doing and ended her NARSAD early.
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 3 Mar 2014 (estimated)
- 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 objective is to examine the efficacy of computerized interventions for increasing well-being and cognitive functioning. The study will seek to validate emerging online delivery methods of psychiatric assessment and treatment. This will allow us to test the efficacy of this intervention in a larger and more geographically broad sample than is possible through traditional recruitment and treatment, and to do so in a highly cost-effective manner.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Therapeutic Computerized interventionParticipants randomized to receive remediation training intervention delivered online (60 days of online training) |
| Control Group | Active comparator | Other: Nontherapeutic computerized interventionParticipants randomized to receive online gaming intervention (60 days of online play) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- computer and broadband internet access
- 18 years of age
- Elevated anxiety and depression
- Native English speaker
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Therapeutic Computerized interventionRemediation training intervention | Other | Treatment Group |
| Nontherapeutic computerized interventionOnline gaming intervention | Other | Control Group |
Primary outcome
Cognitive function
Time frame: 1 month
Behavioral measure of executive functions
1 secondary outcome
Self-report mood and anxiety symptoms
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Dr. Gyurak is no longer doing and ended her NARSAD early.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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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.
Anett Gyurak, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Computerized intervention and Nontherapeutic computerized intervention in people with Cognitive-affective Exercises and Engaging Exercises, run by Stanford University 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 4 inclusion and 0 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 18 Apr 2019. 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: Dr. Gyurak is no longer doing and ended her NARSAD early.). 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?
Cognitive function (time frame: 1 month). 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 18 Apr 2019.