Use of Mobile Apps for Those With PTSD and Their Partners
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|ClinicalTrials.gov Identifier: NCT02780635|
Recruitment Status : Recruiting
First Posted : May 23, 2016
Last Update Posted : June 23, 2017
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 or disease||Intervention/treatment|
|Ptsd||Behavioral: Mobile App + Mailed Materials for managing stress associated with PTSD Behavioral: Mobile App for managing stress associated with PTSD|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Mobile Apps for Those With PTSD and Their Partners|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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 appBehavioral: 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
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780635
|Contact: Jason Owen, PhD||(650) 493-5000 ext email@example.com|
|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 firstname.lastname@example.org|