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

Depression Clinical Trial

Official title:

Web-based "Self-Help" Cognitive Behavioral Therapy for Symptoms of Mild-to-Moderate Anxiety and Depression in Adolescents and Young Adults With Chronic Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02453880
• Other study ID #: 29456
• Status: Completed
• Phase: N/A
• First received: May 19, 2015
• Last updated: April 25, 2016
• Start date: January 2014
• Est. completion date: August 2015

Study information

• Verified date: April 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 25 Years

Eligibility

Inclusion Criteria:

• Diagnosis of chronic illness

• Language: English

• Computer and Internet access

• Symptoms of mild-moderate depression and/or anxiety

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Arthritis, Juvenile
• Chronic Disease
• Depression
• Depressive Disorder
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Juvenile Idiopathic Arthritis
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Behavioral:
• Web-based Cognitive Behavioral Therapy
Participants will be asked to complete a web-based cognitive behavioral therapy "self-help" program. The program consists of six weekly modules, in which participants practice new ways of thinking (e.g. how to recognize and change distorted thinking, utilizing a thought change record, identifying cognitive errors, and modifying automatic thoughts) to reduce symptoms of anxiety and depression. Participants receive text message reminders to complete the weekly session.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Program satisfaction survey	Satisfaction with the web-based program will be assessed with a survey 3 months after enrollment in the study.	3 months	No
Primary	Program completion rates	Intervention completion rates will be used as a marker for acceptability of the intervention.	6 weeks	No
Secondary	Change in pre-and post-intervention score on measure of depression (PHQ-9)		Baseline and 3 months	No
Secondary	Change in pre-and post-intervention score on measure of anxiety (GAD-7)		Baseline and 3 months	No
Secondary	Change in pre-and post-intervention score on measure of quality of life (Peds-QL)		Baseline and 3 months	No
Secondary	Change in pre-and post-intervention score on measure of patient activation (PAM)		Baseline and 3 months	No