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To Observe the Psychophysiological Alterations in Traumatic Stress Subjects

10. srpna 2021 aktualizováno: Shamoon Noushad, University of Karachi

Effects of the Guided Disclosure Protocol on Post-Traumatic Growth: A Randomized Control Trial Designed to Observe Psychophysiological Alterations in Traumatic Stress Subjects

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).

Přehled studie

Postavení

Dokončeno

Intervence / Léčba

Detailní popis

Study design:

The study will be conducted as multicenter randomized controlled trial. On the basis of eligibility criteria subjects providing consent to participate in the study will be randomized into two groups, experimental group including those who receive the intervention and a control group receiving control intervention. The study outcomes will be monitored in subjects of both groups at different intervals i.e. at baseline and at 3-month follow-up (post-interventional).

Participants Subjects for the present study will be recruited from 5 centers (based in Karachi, Pakistan). The targeted population includes subjects from diverse ethnicity and considered eligible for participation in the study if they indicated in a pre-screening form that they had experienced traumatic event. These subjects will be invited to participate in the study through advertisement on notice board of each center. A written informed consent will be obtained from each study subject after providing detailed information regarding objectives of the study and its duration.

Interventions

The experimental intervention (GDP):

It includes three writing sessions of 20 minutes where the participants will be made to recall the facts regarding the traumatic event first and then the emotions triggered related to the revealed facts will be channelized. The information related to the immediate priority changes due to the revival of the traumatic history and its reflection on current feelings will be collected. Moreover, the learned coping mechanisms will also be inquired and how the traumatic event altered their vision and their personalities and how it helps in coping with future difficulties.

The original instructions will be translated into local language and altered according to the specific traumatic experience.

In the following, a fusion of the tasks concerning each of the three writing sessions is shown.

  1. Participants will be required to describe memories associated with traumatic event in a sequential order, with an objective and detached attitude
  2. They will be asked to describe

    1. Their opinion regarding the traumatic event and emotions perceived during the experience
    2. Its impact on their daily lives, and how it has altered their attitudes toward life.
  3. The actual situation will be focused, while reviving the whole traumatic event experience which aids in exploring the following aspects:

    • Present thoughts and feelings regarding the traumatic experience, and also clarify the differences between the ones felt at the time of traumatic event in comparison to the current feelings.
    • How much they understand and appreciate themselves for successfully dealing with the traumatic event
    • To what extent the traumatic event has modified their vision, attitude, knowledge, and skills, and how it can help in their future;
    • What will be their future reactions to other similar events. For the writing session it is mandatory to maintain standard experimental environment with maximum silence so that the subject can write peacefully without getting disturbed. Two weeks after the initial assessment, the first writing session will be performed followed by two sessions once every 2 weeks.

The control intervention:

In control intervention the subjects will be required to take three 20-minute writing sessions, in which they will be asked to write about their daily events of the past week, the writing must focus on the facts and highlight an objective and detached attitude. It has shown potential improvements after the guided disclosure protocol (GDP). Works through the placebo effect. Same protocol will be followed for these subjects as the one used for GDP.

A day prior to each writing session, in both conditions either experimental or control the researcher will communicate with each study subject via telephone in order to give them a reminder to perform the writing task and to check their understanding regarding the instructions given in the booklet. Details regarding the inability to contact the subject will also be recorded in the patient form.

Typ studie

Intervenční

Zápis (Aktuální)

246

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Sindh
      • Karachi, Sindh, Pákistán, 78500
        • Shamoon Noushad

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 50 let (Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  1. Must be disease free, there must be no evidence of any metastatic disease
  2. Property of written and spoken the English language.
  3. Experienced any traumatic event in the last 12 Months

Exclusion Criteria:

  1. Subjects who received a structured psychological intervention for at least 6 months during the last 3 years performed by a psychologist or psychiatrist will be excluded.
  2. Those with a codified psychiatric disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) who received Psychopharmacological treatment during the last 3 years will also be excluded from the study sample.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: The experimental intervention (GDP): It includes three writing
  1. Participants will be required to describe memories associated with traumatic event in a sequential order, with an objective and detached attitude
  2. They will be asked to describe

    1. Their opinion regarding the traumatic event and emotions perceived during the experience
    2. Its impact on their daily lives, and how it has altered their attitudes toward life.
  3. The actual situation will be focused, while reviving the whole traumatic event experience which aids in exploring the following aspects:

    • Present thoughts and feelings regarding the traumatic experience, and also clarify the differences between the ones felt at the time of traumatic event in comparison to the current feelings.
    • How much they understand and appreciate themselves for successfully dealing with the traumatic event
    • To what extent the traumatic event has modified their vision, attitude, knowledge, and skills, and how it can help in their future;
    • What will be their future reactions to other similar events.
Guided Disclosure Protocol
Žádný zásah: The control intervention:
A day prior to each writing session, the researcher will communicate with each study subject via telephone in order to give them a reminder to perform the writing task and to check their understanding regarding the instructions given in the booklet. Details regarding the inability to contact the subject will also be recorded in the patient form.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Post-Traumatic Growth (PTG)
Časové okno: 3 Months
Change in the Post-traumatic Growth Inventory (PTGI) will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
C- Reactive Protein (CRP)
Časové okno: 3 Months
Change in the CRP level will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months
Brain-derived neurotrophic factor (BDNF)
Časové okno: 3 Months
Change in the BDNF level will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months
Interleukin-6 (IL-6)
Časové okno: 3 Months
Change in the IL-6 level will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months
Glutamate
Časové okno: 3 Months
Change in the Glutamate level will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months
Cortisol
Časové okno: 3 Months
Change in the Cortisol level will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months
Alpha waves
Časové okno: 3 Months
Change in the Brain waves (Alpha waves) will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months
Heart Rate Variability
Časové okno: 3 Months
Change in the Heart Rate Variability will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months
Beta waves
Časové okno: 3 Months
Change in the Brain waves (Beta waves) will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Trauma Symptom Checklist 40 (TSC-40)
Časové okno: 3 Months
Change in the Trauma Symptom Checklist 40 (TSC-40) will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months
Traumatic Stress Scale (Sadaf Stress Scale)
Časové okno: 3 Months
Change in the Traumatic Stress Scale will be observed among the subjects enrolled in the GDP group as compared to the control group.
3 Months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

2. prosince 2019

Primární dokončení (Aktuální)

10. srpna 2021

Dokončení studie (Aktuální)

10. srpna 2021

Termíny zápisu do studia

První předloženo

24. prosince 2019

První předloženo, které splnilo kritéria kontroly kvality

31. prosince 2019

První zveřejněno (Aktuální)

6. ledna 2020

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. srpna 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. srpna 2021

Naposledy ověřeno

1. srpna 2021

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • KU-Psychophysiology-5

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ne

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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