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NCT04217863

To Observe the Psychophysiological Alterations in Traumatic Stress Subjects

Completed NA Last updated 11 August 2021
What this trial tests

NA trial testing GDP in Traumatic Stress, Post-Traumatic Growth in 246 participants. Completed in 10 August 2021.

Timeline
2 December 2019
Primary endpoint
10 August 2021
10 August 2021

Quick facts

Lead sponsorUniversity of Karachi
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment246
Start date2 December 2019
Primary completion10 August 2021
Estimated completion10 August 2021
Sites1 location across Pakistan

Drugs / interventions tested

Conditions studied

Sponsor

University of Karachi

Who can join

Adults 18 to 50, any sex, with Traumatic Stress, Post-Traumatic Growth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This Multicenter study is planned to investigate the effectiveness of the guided disclosure protocol for the promotion of post-traumatic growth (PTG), in the traumatic stress subjects and to determine whether PTG is associated with psychophysiological alterations i.e. (C-Reactive Protein, Brain Derived Neurotropic Factor, Interlukin-6, Cortisol, Heart Rate Variability and brain waves). Study subjects meeting eligibility criteria will be randomized into two groups. Guided disclosure protocol (GDP) will be used as intervention vs the control. Blinded treatment will be provided and the subjects will be made to complete study questionnaires (Screening, Traumatic Stress Scale SSS, Trauma Symptom Checklist, Post-traumatic growth Inventory) at baseline and at post-intervention (3-months later).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of GDP

Trials testing the same drug.

Other University of Karachi trials

Trials by the same sponsor.

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Data sources for this page

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