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NCT04217863
To Observe the Psychophysiological Alterations in Traumatic Stress Subjects
NA trial testing GDP in Traumatic Stress, Post-Traumatic Growth in 246 participants. Completed in 10 August 2021.
10 August 2021
Quick facts
| Lead sponsor | University of Karachi |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 246 |
| Start date | 2 December 2019 |
| Primary completion | 10 August 2021 |
| Estimated completion | 10 August 2021 |
| Sites | 1 location across Pakistan |
Drugs / interventions tested
- GDP — full drug profile →
Conditions studied
- Traumatic Stress, Post-Traumatic Growth — all drugs for Traumatic Stress, Post-Traumatic Growth →
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.
Verify or expand the search:
- PubMed search for NCT04217863
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of GDP
Trials testing the same drug.
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Other University of Karachi trials
Trials by the same sponsor.
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- NCT07205042 — Walking for Hypothyroidism Trial (WHT) · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04217863 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Karachi
- Last refreshed: 11 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04217863.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing