Use of Mobile Apps for Those With PTSD and Their Partners
1 other identifier
interventional
152
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 4, 2016
CompletedFirst Posted
Study publicly available on registry
May 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedApril 26, 2019
April 1, 2019
3 years
May 4, 2016
April 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Caregiver Burden
Montgomery Burden Interview
10 weeks
Functional Well-Being
Partner-rated Interpersonal Well-Being Scale
10 weeks
Personal Health Questionnaire Depression Scale
8 Item scale measuring depression.
10 weeks
Generalized Anxiety Symptoms
Generalized Anxiety Disorder-7 Scale (GAD-7)
10 weeks
PTSD Symptoms
5 Item Partner-rated Posttraumatic Stress Disorder Checklist-5 (PCL-5)
10 weeks
Positive Relationship Behaviors
Author-constructed relationship behaviors scale
10 weeks
Stress
Perceived Stress Scale
10 weeks
Secondary Outcomes (4)
Emotional Intimacy
10 weeks
Caregiving Self-Efficacy Scale
10 weeks
Positive Partner Communication
10 weeks
Relationship Self-Efficacy
10 weeks
Study Arms (2)
App + Couples Coach Intervention
EXPERIMENTALBoth 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.
App Alone
ACTIVE COMPARATORBoth members of the couple will receive a mobile app for PTSD: PTSD Coach for the Veteran and PTSD Family Coach for the partner/spouse.
Interventions
PTSD Coach and PTSD Family Coach mobile apps plus mailed "Couples Coach" intervention materials and discussion board added to PTSD Family Coach app
PTSD Coach and PTSD Family Coach mobile apps
Eligibility Criteria
You may qualify if:
- 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:
- A veteran of the U.S. Armed Forces
- Must have a previous diagnosis of PTSD
- Must have access to a smart phone using the iOS operating system
- Must not have previously used PTSD Coach.
- Partners of Veterans must be:
- An intimate partner of a Veteran
- Living with that partner
- Must have access to a smart phone using the iOS operating system
- must be experiencing significant stress
You may not qualify if:
- a) actual or threatened interpersonal violence in the home
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Palo Alto Health Care System Menlo Park Division
Menlo Park, California, 94025, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Psychologist
Study Record Dates
First Submitted
May 4, 2016
First Posted
May 23, 2016
Study Start
December 1, 2015
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
April 26, 2019
Record last verified: 2019-04