Research on Anxiety and Depression: Computer-Assisted Therapy

NCT02817438 | Completed

• 1 other identifier: IRB-36790
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Mood Disorders; Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• Depression and Anxiety Composite Score

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

  12 weeks

Secondary Outcomes (1)

• Quality of Life

  12 weeks

Study Arms (2)

Online Intervention

EXPERIMENTAL

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

Behavioral: Good Days Ahead

Waitlist

NO INTERVENTION

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

Interventions

Good Days Ahead BEHAVIORAL

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.

Online Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previous participation in the RAD study in our laboratory
• + 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)

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Mood Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Tali Ball, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Scholar

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: June 29, 2016
• Study Start: June 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 20, 2019

Record last verified: 2019-03

Locations

US (1)