このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

To Observe the Psychophysiological Alterations in Traumatic Stress Subjects

2021年8月10日 更新者: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).

調査の概要

状態

完了

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

246

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Sindh
      • Karachi、Sindh、パキスタン、78500
        • Shamoon Noushad

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~50年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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
介入なし: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Post-Traumatic Growth (PTG)
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
C- Reactive Protein (CRP)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

その他の成果指標

結果測定
メジャーの説明
時間枠
Trauma Symptom Checklist 40 (TSC-40)
時間枠: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)
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2019年12月2日

一次修了 (実際)

2021年8月10日

研究の完了 (実際)

2021年8月10日

試験登録日

最初に提出

2019年12月24日

QC基準を満たした最初の提出物

2019年12月31日

最初の投稿 (実際)

2020年1月6日

学習記録の更新

投稿された最後の更新 (実際)

2021年8月11日

QC基準を満たした最後の更新が送信されました

2021年8月10日

最終確認日

2021年8月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

GDPの臨床試験

3
購読する