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

April 25, 2016 updated by: Rachel Bensen, Stanford University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Web-based Cognitive Behavioral Therapy
Participants will be directed to a web-based CBT "self-help" program with weekly modules.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program completion rates
Time Frame: 6 weeks
Intervention completion rates will be used as a marker for acceptability of the intervention.
6 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program satisfaction survey
Time Frame: 3 months
Satisfaction with the web-based program will be assessed with a survey 3 months after enrollment in the study.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

May 19, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Estimate)

April 26, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29456

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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