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Research on Anxiety and Depression: Computer-Assisted Therapy (RADCAT)

Primary Purpose

Mood Disorders, Anxiety Disorders

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Good Days Ahead

About this trial

This is an interventional treatment trial for Mood Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Previous participation in the RAD study in our laboratory

RAD study inclusion criteria are:

18+ years of age
Fluent and literate in English
Can provide informed consent
fMRI scanning eligibility, including no evidence of any form of metal embedded in the body (e.g., metal wires, nuts, bolts, screws, plates, sutures)

Exclusion Criteria:

Anyone who has not already completed the RAD study will be excluded.

RAD study exclusion criteria are:

Presence of suicidal ideations representing imminent risk
General medical condition, disease, or neurological disorder that interferes with the assessments
Mild traumatic brain injury (history of physical brain injury or blow to the head resulting in loss of consciousness greater than five minutes) and which could interfere with doing the assessments
Severe impediment to vision, hearing and/or hand movement, likely to interfere with ability to complete the assessments
Unable and/or unlikely to follow the study protocols
Pregnant or breastfeeding

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Online Intervention

Waitlist

Arm Description

Participants randomized to the online intervention arm will be given access to the Good Days Ahead program for 12 weeks.

Participants randomized to the waitlist arm will wait for 12 weeks without doing an online intervention.

Outcomes

Primary Outcome Measures

Depression and Anxiety Composite Score

Composite score combining 3 measures of depression and/or anxiety (PHQ-9, BAI, DASS)

Secondary Outcome Measures

Quality of Life

WHOQOL scale

Full Information

NCT ID

NCT02817438

First Posted

June 27, 2016

Last Updated

March 18, 2019

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT02817438

Brief Title

Research on Anxiety and Depression: Computer-Assisted Therapy

Acronym

RADCAT

Official Title

Research on Anxiety and Depression: Computer-Assisted Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

June 2016 (undefined)

Primary Completion Date

March 2018 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study examines how online self-guided programs can improve mood and anxiety symptoms. These programs use exercises from Cognitive-Behavioral Therapy, which is an evidence-based treatment for depression and anxiety. The purpose of this study is to learn who will do best with the online format. Our aim is to learn for whom online self-guided interventions are most efficacious. This knowledge is important because it will help inform clinicians and patients about who might benefit from this type of intervention versus who would need the assistance of a therapist. More specifically, we hope to figure out who would benefit from solely an online intervention and who would benefit from an online intervention in addition to other treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mood Disorders, Anxiety Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

136 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Online Intervention

Arm Type

Experimental

Arm Description

Participants randomized to the online intervention arm will be given access to the Good Days Ahead program for 12 weeks.

Arm Title

Waitlist

Arm Type

No Intervention

Arm Description

Participants randomized to the waitlist arm will wait for 12 weeks without doing an online intervention.

Intervention Type

Behavioral

Intervention Name(s)

Good Days Ahead

Intervention Description

Good Days Ahead is a web-based program based on the principles of Cognitive Behavioral Therapy (CBT). It can be used to supplement traditional psychotherapy, or as a stand-alone intervention. There are 9 lessons that address Thinking Skills, Behavioral Skills, Schemas, and Coping Tools. Lessons include videos from expert therapists and a Practice Section in which patients complete forms for self-monitoring symptoms and challenging negative thoughts.

Primary Outcome Measure Information:

Title

Depression and Anxiety Composite Score

Description

Composite score combining 3 measures of depression and/or anxiety (PHQ-9, BAI, DASS)

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Quality of Life

Description

WHOQOL scale

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Previous participation in the RAD study in our laboratory RAD study inclusion criteria are: 18+ years of age Fluent and literate in English Can provide informed consent fMRI scanning eligibility, including no evidence of any form of metal embedded in the body (e.g., metal wires, nuts, bolts, screws, plates, sutures) Exclusion Criteria: Anyone who has not already completed the RAD study will be excluded. RAD study exclusion criteria are: Presence of suicidal ideations representing imminent risk General medical condition, disease, or neurological disorder that interferes with the assessments Mild traumatic brain injury (history of physical brain injury or blow to the head resulting in loss of consciousness greater than five minutes) and which could interfere with doing the assessments Severe impediment to vision, hearing and/or hand movement, likely to interfere with ability to complete the assessments Unable and/or unlikely to follow the study protocols Pregnant or breastfeeding

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tali Ball, PhD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Research on Anxiety and Depression: Computer-Assisted Therapy

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