Mobile Apps for the Treatment of Depression
Primary Purpose
Major Depressive Disorder
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral activation plus mobile app
Standard behavioral activation
Sponsored by
About this trial
This is an interventional health services research trial for Major Depressive Disorder focused on measuring depression, technology, psychotherapy, behavioral activation
Eligibility Criteria
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
Sites / Locations
- Central Arkansas Veterans Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Behavioral activation plus mobile app
Standard behavioral activation
Arm Description
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.
Standard behavioral activation protocol using paper and pencil forms for treatment delivery and homework completion.
Outcomes
Primary Outcome Measures
Change in Behavioral Activation for Depression Scale-Short Form
Measures symptoms of depression consistent with a behavioral deficits model in a brief format.
Secondary Outcome Measures
Change in Depression Anxiety Stress Scales-21
Assesses symptoms of depression, anxiety, and stress in a brief format.
Full Information
NCT ID
NCT02024620
First Posted
December 4, 2013
Last Updated
December 14, 2015
Sponsor
Central Arkansas Veterans Healthcare System
Collaborators
National Center for PTSD
1. Study Identification
Unique Protocol Identification Number
NCT02024620
Brief Title
Mobile Apps for the Treatment of Depression
Official Title
Evaluation of Mood Coach in the Treatment of Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
The mobile phone app upon which the study was based was not available.
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Arkansas Veterans Healthcare System
Collaborators
National Center for PTSD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, technology, psychotherapy, behavioral activation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral activation plus mobile app
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard behavioral activation
Arm Type
Active Comparator
Arm Description
Standard behavioral activation protocol using paper and pencil forms for treatment delivery and homework completion.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral activation plus mobile app
Intervention Type
Behavioral
Intervention Name(s)
Standard behavioral activation
Primary Outcome Measure Information:
Title
Change in Behavioral Activation for Depression Scale-Short Form
Description
Measures symptoms of depression consistent with a behavioral deficits model in a brief format.
Time Frame
Week 1, Week 4, Week 8
Secondary Outcome Measure Information:
Title
Change in Depression Anxiety Stress Scales-21
Description
Assesses symptoms of depression, anxiety, and stress in a brief format.
Time Frame
Week 1, Week 4, Week 8
Other Pre-specified Outcome Measures:
Title
Homework Compliance Rating Scale
Description
Assesses the amount of effort put into the weekly behavioral activation homework. Completed by the participant and the study clinician.
Time Frame
Week 4, Week 8
Title
Treatment Evaluation Inventory-Short Form
Description
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.
Time Frame
Week 4, Week 8
Title
Perceptions of Computerized Therapy Questionnaire-Patient Version
Description
Measures participants' opinion of computerized and computer-assisted psychotherapy.
Time Frame
Week 1, Week 8
Title
Mini-International Neuropsychiatric Interview
Description
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.
Time Frame
Week 1, Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert E Brady, Ph.D.
Organizational Affiliation
Central Arkansas Veterans Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Arkansas Veterans Healthcare System
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21324944
Citation
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.
Results Reference
background
PubMed Identifier
21130939
Citation
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.
Results Reference
background
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Mobile Apps for the Treatment of Depression
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