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To Observe the Psychophysiological Alterations in Traumatic Stress Subjects

10. August 2021 aktualisiert von: 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).

Studienübersicht

Status

Abgeschlossen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

246

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Sindh
      • Karachi, Sindh, Pakistan, 78500
        • Shamoon Noushad

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 50 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Post-Traumatic Growth (PTG)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
C- Reactive Protein (CRP)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Trauma Symptom Checklist 40 (TSC-40)
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

2. Dezember 2019

Primärer Abschluss (Tatsächlich)

10. August 2021

Studienabschluss (Tatsächlich)

10. August 2021

Studienanmeldedaten

Zuerst eingereicht

24. Dezember 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. Dezember 2019

Zuerst gepostet (Tatsächlich)

6. Januar 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. August 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. August 2021

Zuletzt verifiziert

1. August 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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