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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
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
June 27, 2016
Last Updated
March 18, 2019
Sponsor
Stanford University
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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
No

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
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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