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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02817438
Other study ID # IRB-36790
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date March 2018

Study information

Verified date March 2019
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Good Days Ahead
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.

Locations

Country Name City State
United States Stanford University Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depression and Anxiety Composite Score Composite score combining 3 measures of depression and/or anxiety (PHQ-9, BAI, DASS) 12 weeks
Secondary Quality of Life WHOQOL scale 12 weeks
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