Clinical trial NCT02400710: Clinician-Supported PTSD Coach vs. Self-Managed PTSD Coach
Official title: Clinician-Supported PTSD Coach vs. Self-Managed PTSD Coach: A Pilot Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Lead sponsor: Syracuse VA Medical Center
Sponsor class: FED
First posted: 2015-03-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PTSD Coach is a mobile application (app) that aims to teach individuals self-management strategies for symptoms of Post-traumatic Stress Disorder (PTSD). Despite PTSD Coach's use of evidence-based cognitive behavioral strategies there is still a need to test the effectiveness of the app in managing PTSD symptoms. There is research evidence that self-management programs are often underutilized, but that clinician contact can increase patient involvement. The addition of clinician support may enhance the utilization and effectiveness of the PTSD Coach. In Phase 1 the investigators propose to conduct stakeholder interviews with primary care (PC) and mental health (MH) leadership staff to investigate barriers and facilitators to implementing Clinician-Supported (CS-PTSD Coach) to increase the uptake, use, and impact of PTSD Coach by PC patients. The interviews will inform the development of a CS-PTSD Coach protocol and manual that will be used in phase 2. In phase 2 the investigators propose to conduct a feasibility study where 30 (20 eligible) PC Veterans with diagnostic-level or subthreshold PTSD symptoms will be randomized to receive Self-Managed (SM) PTSD Coach or CS-PTSD Coach. The investigators' specific aims are to 1) investigate the feasibility of recruiting and retaining participants and delivering the SM and CS conditions and 2) conduct a preliminary investigation of the efficacy of SM vs. CS. The investigators predict that CS will lead to greater treatment gains than SM. Effect sizes will be generated for the following outcomes: a) reductions in PTSD, depression, and general distress, and increases in health-related functioning, b) increases in knowledge about PTSD symptoms, PTSD management strategies, and patient coping self-efficacy, c) increases in initiation of tradition PTSD treatments.


Eligibility criteria: Inclusion Criteria:

1. Enrolled in primary care at the Syracuse VAMC,
2. Significant PTSD symptoms. Total PTSD Checklist Score ≥ 40.

Exclusion Criteria:

1. Gross cognitive impairment (as measured by the Blessed Orientation-Memory-Concentration; BOMC)
2. Suicide attempt or intent to commit suicide in the last two months (as measured by the Columbia- Suicide Severity Rating Scale
3. Psychotherapy or mental health counseling for PTSD in the last two months that was received outside of VA primary care
4. A new psychotropic medication or a change in dose of a psychotropic medication for PTSD in the last two months that was received outside of VA primary care
5. Intent to begin PTSD treatment in specialty care

Primary outcomes:
measure: PTSD Checklist-Specific
timeFrame: 8 weeks
Secondary outcomes:
measure: Engagement in PTSD Specialty Care as Measured by the Electronic Medical Record
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse VMAC
state: New York
Study officials:
affiliation: Syracuse VAMC
name: Kyle Possemato, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: