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Use of Mobile Apps for Those With PTSD and Their Partners

This study is currently recruiting participants.
Verified June 2017 by Jason Owen, VA Palo Alto Health Care System
Sponsor:
ClinicalTrials.gov Identifier:
NCT02780635
First Posted: May 23, 2016
Last Update Posted: June 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jason Owen, VA Palo Alto Health Care System
  Purpose

In layperson's language state the purpose of the study in 3-5 sentences.

Previous research has demonstrated that intimate partners can positively influence those with PTSD to seek treatment. The investigators have preliminary evidence to demonstrate that mobile apps, such as PTSD Coach can be helpful for those with PTSD, and the current study will provide Veterans with PTSD and their partners with a mobile app designed to promote engagement with evidence-based treatments for PTSD. The purpose of this PILOT study is to evaluate methods for delivering a couples-based intervention to reduce PTSD symptoms and improve relationship quality in Veterans and their intimate partners.

b) State what the Investigator(s) hope to learn from the study. Include an assessment of the importance of this new knowledge.

Understanding ways to improve the public health impact of public-facing, evidence-based mobile apps is critical. This study will test a low-cost, "high-touch" approach to improving the outcomes associated with use of the PTSD Coach and PTSD Family Coach mobile apps,which are already available to the general public and used by over 55,000 new users per year.This study will test whether the involvement of an intimate partner in the use of a mobile app for PTSD will result in changes in how the mobile apps are used and in relationship quality and PTSD symptoms over time. Additionally, this study will test whether the addition of a discussion board can improve engagement with the apps and/or outcomes. The study will also provide useful qualitative data that can inform the development of subsequent dyadic interventions using mobile technologies.

c) Explain why human subjects must be used for this project. (i.e. purpose of study is to test efficacy of investigational device in individuals with specific condition; purpose of study is to examine specific behavioral traits in humans in classroom or other environment)

The purpose of this study is to evaluate how Veterans and their partners interact with evidence-based mobile apps for improving PTSD symptoms.


Condition Intervention
Ptsd Behavioral: Mobile App + Mailed Materials for managing stress associated with PTSD Behavioral: Mobile App for managing stress associated with PTSD

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Mobile Apps for Those With PTSD and Their Partners

Further study details as provided by Jason Owen, VA Palo Alto Health Care System:

Primary Outcome Measures:
  • Caregiver Burden [ Time Frame: 10 weeks ]
    Montgomery Burden Interview

  • Functional Well-Being [ Time Frame: 10 weeks ]
    Partner-rated Interpersonal Well-Being Scale

  • Personal Health Questionnaire Depression Scale [ Time Frame: 10 weeks ]
    8 Item scale measuring depression.

  • Generalized Anxiety Symptoms [ Time Frame: 10 weeks ]
    Generalized Anxiety Disorder-7 Scale (GAD-7)

  • PTSD Symptoms [ Time Frame: 10 weeks ]
    5 Item Partner-rated Posttraumatic Stress Disorder Checklist-5 (PCL-5)

  • Positive Relationship Behaviors [ Time Frame: 10 weeks ]
    Author-constructed relationship behaviors scale

  • Stress [ Time Frame: 10 weeks ]
    Perceived Stress Scale


Secondary Outcome Measures:
  • Emotional Intimacy [ Time Frame: 10 weeks ]
    Personal Assessment of Intimacy in Relationships (PAIR) Scale

  • Caregiving Self-Efficacy Scale [ Time Frame: 10 weeks ]
    Author-constructed questionnaire

  • Positive Partner Communication [ Time Frame: 10 weeks ]
    Measured with items combined from the Social Constraints Scale and Communication Danger Signs Scale

  • Relationship Self-Efficacy [ Time Frame: 10 weeks ]
    Author-constructed questionnaire


Estimated Enrollment: 200
Study Start Date: December 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: App + Couples Coach Intervention
Both members of the couple will receive a mobile app for PTSD: PTSD Coach for the Veteran and PTSD Family Coach for the partner/spouse. Those assigned to this arm will also receive mailed materials that are designed to help increase positive communication strategies.
Behavioral: Mobile App + Mailed Materials for managing stress associated with PTSD
PTSD Coach and PTSD Family Coach mobile apps plus mailed "Couples Coach" intervention materials and discussion board added to PTSD Family Coach app
Behavioral: Mobile App for managing stress associated with PTSD
PTSD Coach and PTSD Family Coach mobile apps
Active Comparator: App Alone
Both members of the couple will receive a mobile app for PTSD: PTSD Coach for the Veteran and PTSD Family Coach for the partner/spouse.
Behavioral: Mobile App for managing stress associated with PTSD
PTSD Coach and PTSD Family Coach mobile apps

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be eligible to participate, participants must be either a Veteran with PTSD or living with a partner who is a Veteran with PTSD.

Veterans must be:

  1. A veteran of the U.S. Armed Forces
  2. Must have a previous diagnosis of PTSD
  3. Must have access to a smart phone using the iOS operating system
  4. Must not have previously used PTSD Coach.

Partners of Veterans must be:

  1. An intimate partner of a Veteran
  2. Living with that partner
  3. Must have access to a smart phone using the iOS operating system
  4. must be experiencing significant stress

Exclusion Criteria:

a) actual or threatened interpersonal violence in the home

  Contacts and Locations
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): NCT02780635


Contacts
Contact: Jason Owen, PhD (650) 493-5000 ext 23478 jason.owen@va.gov

Locations
United States, California
VA Palo Alto Health Care System Menlo Park Division Recruiting
Menlo Park, California, United States, 94025
Contact: Jason Owen, PhD    650-493-5000 ext 23478    jason.owen@va.gov   
Sponsors and Collaborators
VA Palo Alto Health Care System
  More Information

Responsible Party: Jason Owen, Clinical Psychologist, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT02780635     History of Changes
Other Study ID Numbers: 33003
First Submitted: May 4, 2016
First Posted: May 23, 2016
Last Update Posted: June 23, 2017
Last Verified: June 2017

Keywords provided by Jason Owen, VA Palo Alto Health Care System:
family, caregiving, ptsd, couples