- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02024620
Mobile Apps for the Treatment of Depression
December 14, 2015 updated by: Central Arkansas Veterans Healthcare System
Evaluation of Mood Coach in the Treatment of Major Depressive Disorder
Smartphone applications (apps) may be well-suited as a low cost adjunctive tool for increasing the adherence of individuals to psychotherapy treatments which may subsequently increase symptom reduction and improve clinical outcomes.
Apps offer the opportunity for real-time tracking of behavior and have the ability to provide prompt feedback and reminders in a convenient, readily available technology.
The immediacy and convenience of apps may be responsible for the observed improvements in adherence on the part of the patients relative to traditional paper-and-pencil tracking and practice of skills taught in psychotherapy.
These features are relevant to behavioral activation (BA) protocols, the effects of which are often attenuated by failure to adhere to regular practice and tracking of behavior.
The Mood Coach app is a BA protocol developed to provide a convenient means of planning and tracking activity, and monitoring mood responses to scheduled increases in activity.
This project evaluates the utility of this app as an adjunct to standard BA treatment.
The investigators predict that participants assigned to the BA+app condition will demonstrate greater adherence to the BA treatment compared to the standard BA condition.
The investigators also predict that the participants in the BA+app condition will report greater satisfaction with the app compared to the standard BA protocol that utilizes paper and pencil materials.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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North Little Rock, Arkansas, United States, 72114
- Central Arkansas Veterans Healthcare System
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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
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Veterans aged 18 and older
- Speak and understand English
- Meet criteria for major depressive disorder
- Willing to participate in psychotherapy for depression
Exclusion Criteria:
- Current psychotic disorder diagnosis
- Current bipolar disorder
- Diagnosed with a substance use disorder that is not currently being addressed by a non-study provider
- Patients receiving a concurrent evidence-based psychotherapy for depression or PTSD
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioral activation plus mobile app
Standard behavioral activation protocol with the addition of the Mood Coach mobile app to replace the paper and pencil forms used in the standard protocol.
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Active Comparator: Standard behavioral activation
Standard behavioral activation protocol using paper and pencil forms for treatment delivery and homework completion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Behavioral Activation for Depression Scale-Short Form
Time Frame: Week 1, Week 4, Week 8
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Measures symptoms of depression consistent with a behavioral deficits model in a brief format.
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Week 1, Week 4, Week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Depression Anxiety Stress Scales-21
Time Frame: Week 1, Week 4, Week 8
|
Assesses symptoms of depression, anxiety, and stress in a brief format.
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Week 1, Week 4, Week 8
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Homework Compliance Rating Scale
Time Frame: Week 4, Week 8
|
Assesses the amount of effort put into the weekly behavioral activation homework.
Completed by the participant and the study clinician.
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Week 4, Week 8
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Treatment Evaluation Inventory-Short Form
Time Frame: Week 4, Week 8
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Assesses the degree to which the treatment provided in the project is deemed acceptable by the participant.
The measure used in the present project is modified from the original to better assess the treatment procedures in an adult population.
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Week 4, Week 8
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Perceptions of Computerized Therapy Questionnaire-Patient Version
Time Frame: Week 1, Week 8
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Measures participants' opinion of computerized and computer-assisted psychotherapy.
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Week 1, Week 8
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Mini-International Neuropsychiatric Interview
Time Frame: Week 1, Week 8
|
Clinician-administered brief diagnostic interview for psychiatric diagnoses.
The selected sections for this project include the major depressive disorder, dysthymic disorder, bi-polar disorder, panic disorder, obsessive-compulsive disorder, generalized anxiety, disorder, social anxiety disorder, post-traumatic stress disorder, and substance use disorder sections.
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Week 1, Week 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Robert E Brady, Ph.D., Central Arkansas Veterans Healthcare System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Newman MG, Szkodny LE, Llera SJ, Przeworski A. A review of technology-assisted self-help and minimal contact therapies for anxiety and depression: is human contact necessary for therapeutic efficacy? Clin Psychol Rev. 2011 Feb;31(1):89-103. doi: 10.1016/j.cpr.2010.09.008. Epub 2010 Oct 14.
- Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.
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
March 1, 2014
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
December 4, 2013
First Submitted That Met QC Criteria
December 26, 2013
First Posted (Estimate)
December 31, 2013
Study Record Updates
Last Update Posted (Estimate)
December 15, 2015
Last Update Submitted That Met QC Criteria
December 14, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 529128
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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