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Trial record 1 of 3 for:    21130939 [PUBMED-IDS]
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Mobile Apps for the Treatment of Depression

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ClinicalTrials.gov Identifier: NCT02024620
Recruitment Status : Withdrawn (The mobile phone app upon which the study was based was not available.)
First Posted : December 31, 2013
Last Update Posted : December 15, 2015
Sponsor:
Collaborator:
National Center for PTSD
Information provided by (Responsible Party):
Central Arkansas Veterans Healthcare System

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Behavioral activation plus mobile app Behavioral: Standard behavioral activation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of Mood Coach in the Treatment of Major Depressive Disorder
Study Start Date : March 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


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.
Behavioral: Behavioral activation plus mobile app
Active Comparator: Standard behavioral activation
Standard behavioral activation protocol using paper and pencil forms for treatment delivery and homework completion.
Behavioral: Standard behavioral activation



Primary Outcome Measures :
  1. Change in Behavioral Activation for Depression Scale-Short Form [ Time Frame: Week 1, Week 4, Week 8 ]
    Measures symptoms of depression consistent with a behavioral deficits model in a brief format.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. Treatment Evaluation Inventory-Short Form [ Time Frame: Week 4, Week 8 ]
    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.

  3. Perceptions of Computerized Therapy Questionnaire-Patient Version [ Time Frame: Week 1, Week 8 ]
    Measures participants' opinion of computerized and computer-assisted psychotherapy.

  4. 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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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024620


Locations
United States, Arkansas
Central Arkansas Veterans Healthcare System
North Little Rock, Arkansas, United States, 72114
Sponsors and Collaborators
Central Arkansas Veterans Healthcare System
National Center for PTSD
Investigators
Principal Investigator: Robert E Brady, Ph.D. Central Arkansas Veterans Healthcare System

Publications:
Responsible Party: Central Arkansas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT02024620     History of Changes
Other Study ID Numbers: 529128
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015

Keywords provided by Central Arkansas Veterans Healthcare System:
depression
technology
psychotherapy
behavioral activation

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms