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Expressive Writing, Control Writing

Phase 2

Posttraumatic Stress Disorder | Unknown | Other |United Therapeutics Corporation|Last Updated: Sep 23, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment1,292
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00640445Military to Civilian: Trial of an Intervention to Promote Postdeployment ReintegrationPHASE2 COMPLETED 1,292Jun 1, 2011Sep 1, 2013Sep 23, 20151 United States
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Study Endpoints
Primary Endpoints
PTSD symptoms
Baseline, 3-month, 6-month
Hostility
Baseline, 3-month, 6-month
Psychological distress
Baseline, 3-month, 6-month
Physical symptoms
Baseline, 3-month, 6-month
Reintegration difficulty
Baseline, 3-month, 6-month
Social support
Baseline, 3-month, 6-month
Life satisfaction
Baseline, 3-month, 6-month
Secondary Endpoints
Emotion and causal word use in participants' essays
Intervention Sessions (up to 4 sessions post-baseline for participants assigned to a writing condition)
Employment status
Baseline, 3-month, 6-month
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelFACTORIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Expressive WritingEXPERIMENTALParticipants assigned to the Expressive Writing (EW) condition will write about their deepest thoughts and feelings associated with their experience transitioning from being a soldier to being a civilian for 20 minutes a day for 4 days within a week.
Control WritingACTIVE_COMPARATORThose assigned to control writing condition will write factually about the information needs of veterans transitioning from active duty to civilian status for 20 minutes on 4 days within one week.
No Writing ControlNO_INTERVENTIONTreatment As Usual
Interventions
NameTypeDescription
Expressive WritingBEHAVIORALIn EW, people are asked to write about their deepest thoughts and feelings surrounding a significant life event for 20 minutes a day for 4 days
Control WritingBEHAVIORALThose assigned to control writing conditions are asked to describe factual information for 20 minutes a day for 4 days.
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Eligibility Criteria
Age Range19 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Veteran from current wars in Iraq and Afghanistan * At least a little difficulty transitioning from soldier to civilian * Access to computer with internet * Provide valid contact information * Available to participate for up to 40 minutes per session * Interested in participat...

Countries:United States
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