Research on Anxiety and Depression: Computer-Assisted Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Research on Anxiety and Depression: Computer-Assisted Therapy

Conditions
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Mood Disorders, Anxiety Disorders

Intervention / Treatment
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* Behavioral: Good Days Ahead


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online Intervention<br>Participants randomized to the online intervention arm will be given access to the Good Days Ahead program for 12 weeks. | Behavioral: Good Days Ahead<br>* 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.<br>|
| No Intervention: Waitlist<br>Participants randomized to the waitlist arm will wait for 12 weeks without doing an online intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression and Anxiety Composite Score | Composite score combining 3 measures of depression and/or anxiety (PHQ-9, BAI, DASS) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | WHOQOL scale | 12 weeks |