Web-based CBT for Symptoms of Mild-to-Moderate Anxiety and Depression in Youth With Chronic Illness
Primary Purpose
Depression, Anxiety, Inflammatory Bowel Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Web-based Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional prevention trial for Depression focused on measuring anxiety, depression, chronic illness, teen, young adult
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Web-based Cognitive Behavioral Therapy
Arm Description
Participants will be directed to a web-based CBT "self-help" program with weekly modules.
Outcomes
Primary Outcome Measures
Program completion rates
Intervention completion rates will be used as a marker for acceptability of the intervention.
Secondary Outcome Measures
Change in pre-and post-intervention score on measure of depression (PHQ-9)
Change in pre-and post-intervention score on measure of anxiety (GAD-7)
Change in pre-and post-intervention score on measure of quality of life (Peds-QL)
Change in pre-and post-intervention score on measure of patient activation (PAM)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02453880
Brief Title
Web-based CBT for Symptoms of Mild-to-Moderate Anxiety and Depression in Youth With Chronic Illness
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Inflammatory Bowel Disease, Systemic Lupus Erythematosus, Juvenile Idiopathic Arthritis
Keywords
anxiety, depression, chronic illness, teen, young adult
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Web-based Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Participants will be directed to a web-based CBT "self-help" program with weekly modules.
Intervention Type
Behavioral
Intervention Name(s)
Web-based Cognitive Behavioral Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Program completion rates
Description
Intervention completion rates will be used as a marker for acceptability of the intervention.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in pre-and post-intervention score on measure of depression (PHQ-9)
Time Frame
Baseline and 3 months
Title
Change in pre-and post-intervention score on measure of anxiety (GAD-7)
Time Frame
Baseline and 3 months
Title
Change in pre-and post-intervention score on measure of quality of life (Peds-QL)
Time Frame
Baseline and 3 months
Title
Change in pre-and post-intervention score on measure of patient activation (PAM)
Time Frame
Baseline and 3 months
Other Pre-specified Outcome Measures:
Title
Program satisfaction survey
Description
Satisfaction with the web-based program will be assessed with a survey 3 months after enrollment in the study.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Web-based CBT for Symptoms of Mild-to-Moderate Anxiety and Depression in Youth With Chronic Illness
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