Trial of a Nationwide Cognitive-Affective Remediation Tra... | NCT02075190

Studies
Trial of a Nationwide Cognitive-Affective Remediation Training Intervention in Depression

NCT02075190

Sponsor

Stanford University

Status

Terminated

Last Update Posted

Apr 18, 2019Actual

Enrollment

89Actual

Phase

Not Applicable

Conditions

Cognitive-affective Exercises
Engaging Exercises

Interventions

Therapeutic Computerized intervention
Nontherapeutic computerized intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Dr. Gyurak is no longer doing and ended her NARSAD early.

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Feb 27, 2014

First Submission Date that Met QC Criteria

Feb 28, 2014

First Posted Date

Mar 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2019

Last Update Posted Date

Apr 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

89Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group	Experimental	Participants randomized to receive remediation training intervention delivered online (60 days of online training)	Other: Therapeutic Computerized intervention
Control Group	Active Comparator	Participants randomized to receive online gaming intervention (60 days of online play)	Other: Nontherapeutic computerized intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Therapeutic Computerized intervention	Other	Remediation training intervention	Treatment Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognitive function	Behavioral measure of executive functions	1 month

Secondary Outcomes

Measure	Description	Time Frame
Self-report mood and anxiety symptoms		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

computer and broadband internet access
18 years of age
Elevated anxiety and depression
Native English speaker

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anett Gyurak, PhD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Stanford	California	94035	United States