Web-based CBT for Symptoms of Mild-to-Moderate Anxiety and Depression in Youth With Chronic Illness

Not Applicable

Completed

• Conditions: Juvenile Idiopathic Arthritis; Depression; Inflammatory Bowel Disease; Systemic Lupus Erythematosus; Anxiety
• Interventions: Behavioral: Web-based Cognitive Behavioral Therapy

• Registration Number: NCT02453880
• Lead Sponsor: Stanford University

Brief Summary

Symptoms of anxiety and depression are common in adolescents and young adults with chronic illnesses and are associated with decreased adherence to medical regimens. However, many young patients go untreated for anxiety and depression. The purpose of this study is to evaluate an online cognitive behavioral therapy (CBT) program in young adults with chronic illness. Prior research has shown online CBT to be effective in multiple other populations, but to the investigators' knowledge, this is the first study to examine web-based CBT for young adults with chronic illnesses.

Detailed Description

Emotional problems such as anxiety and depression commonly surface during adolescence and are even more common among youth with chronic illness compared to other children. Emotional comorbidities are associated with decreased adherence to medical regimens in children and adults as well as poorer clinical outcomes for medical conditions and increased medical expenditures. It is widely accepted that cognitive behavioral therapy is an effective treatment for anxiety and depression and in-person CBT has been shown effective for young people with inflammatory bowel disease (IBD). However, despite the presence of this effective treatment, the majority of those with anxiety and depression are untreated.

Offering mental health services in an acceptable, feasible and low cost fashion remains a challenge.

Research suggests that web-based CBT is a promising candidate for offering effective and feasible treatment for anxiety and depression to young people. It has been shown effective for mild to moderate symptoms of depression and anxiety in adults and adolescents with a primary diagnosis of depression. In adults, studies comparing face-to-face CBT treatment to web-based CBT with low level therapist support showed comparable clinical outcomes and a 15% cost savings for online treatment. Furthermore, an online treatment format may be especially appealing for younger populations who spend much of their time online as well as for people with chronic illness, who may be home-bound due to symptoms. Despite the well-established evidence base for web-based CBT in other populations, the greater affordability of web-based CBT compared to face-to-face treatment, and the appeal of the online format for young adults, the investigators are aware of no published studies examining the use of web-based CBT for young adults with chronic illness. The innovation of the proposed project is to study low- cost, web-based CBT in a new population of adolescents and young adults with inflammatory conditions that constitute serious chronic illness.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-05
• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-27
• Study Completion: 2015-08
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Diagnosis of chronic illness
• Language: English
• Computer and Internet access
• Symptoms of mild-moderate depression and/or anxiety

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Exclusion Criteria

• Existing mental health diagnosis
• Psychoactive medications initiated in past 2 months
• Severe depression
• Suicidal ideation (refer to on-call psychiatrist and/or social worker for urgent intervention) or history of prior suicide attempt

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Web-based Cognitive Behavioral Therapy	Web-based Cognitive Behavioral Therapy	Participants will be directed to a web-based CBT "self-help" program with weekly modules.

Primary Outcome Measures

Name	Time	Method
Program completion rates	6 weeks	Intervention completion rates will be used as a marker for acceptability of the intervention.

Secondary Outcome Measures

Name	Time	Method
Change in pre-and post-intervention score on measure of depression (PHQ-9)	Baseline and 3 months
Change in pre-and post-intervention score on measure of quality of life (Peds-QL)	Baseline and 3 months
Change in pre-and post-intervention score on measure of patient activation (PAM)	Baseline and 3 months
Change in pre-and post-intervention score on measure of anxiety (GAD-7)	Baseline and 3 months