NCT02486705

Brief Summary

The proposed pilot study is designed to test the feasibility, acceptability, and potential effectiveness of a mobile phone application (app) developed by the VA National Center for PTSD (VA NCPTSD) for use by family members of those with Posttraumatic Stress Disorder (PTSD). The primary objective of the proposed study is to assess whether family members of veterans with PTSD find the PTSD Family Coach app to be satisfactory and feasible to use. Secondary objectives are to determine if use of the app increases family members' self-efficacy and their ability to manage their own life stress, which may in part be the result of living with someone who has PTSD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

8 months

First QC Date

April 21, 2015

Last Update Submit

September 3, 2015

Conditions

Stress Disorders, Post-Traumatic

Keywords

ptsdfamilycaregiverburden

Outcome Measures

Primary Outcomes (6)

  • Caregiver Burden (Montgomery Burden Interview)

    1 month

  • Stress (Perceived Stress Scale)

    1 month

  • Use of PTSD Family Coach Mobile App (Study-Specific Survey)

    1 month

  • Satisfaction with PTSD Family Coach Mobile App (Study-Specific Survey)

    1 month

  • Depression (PHQ-8)

    1 month

  • Anxiety (GAD)

    1 month

Secondary Outcomes (5)

  • Stigma Associated with Seeking Mental Health Care (Study-Specific Measure)

    1 month

  • Perceived Benefits of Mental Health Treatment for PTSD (Study-Specific Measure)

    1 month

  • Social Constraints (Social Constraints Scale)

    1 month

  • Partner Self-Efficacy (Study-Specific Measure)

    1 month

  • Veteran Interest in Treatment for PTSD (Study-Specific Measure)

    1 month

Study Arms (2)

PTSD Family Coach Basic

ACTIVE COMPARATOR

PTSD Coach basic provides an iOS mobile app with extensive information about caregiving for family members of those with PTSD and additional support resources.

Behavioral: PTSD Family Coach Basic

PTSD Family Coach Full

EXPERIMENTAL

PTSD Family Coach full provides an iOS mobile app with extensive information about caregiving for family members of those with PTSD, additional support resources, tools for coping with caregiving-related stress, and tools for self-monitoring stress symptoms.

Behavioral: PTSD Family Coach Full

Interventions

PTSD Family Coach FullBEHAVIORAL

PTSD Family Coach mobile app is an iOS mobile phone application designed to provide information, support resources, tools for coping with caregiver-related stress, and tools for self-monitoring stress symptoms.

Also known as: PTSD Family Coach app- full version
PTSD Family Coach Full
PTSD Family Coach BasicBEHAVIORAL

PTSD Family Coach mobile app is an iOS mobile phone application designed to provide information and support resources,

Also known as: PTSD Family Coach app- basic version
PTSD Family Coach Basic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • currently living with a Veteran with significant PTSD symptoms
  • age 18 or older
  • own an iPhone, iPad or other iOS compatible device
  • currently experiencing at least moderate symptoms of stress

You may not qualify if:

  • currently enrolled in another study related to PTSD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System

Menlo Park, California, 94025, United States

Location

Related Publications (1)

  • van Stolk-Cooke K, Wielgosz J, Hallenbeck HW, Chang A, Rosen C, Owen J, Kuhn E. The PTSD Family Coach App in Veteran Family Members: Pilot Randomized Controlled Trial. JMIR Form Res. 2023 Jan 5;7:e42053. doi: 10.2196/42053.

    PMID: 36602852DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

April 21, 2015

First Posted

July 1, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

US(1)