To Observe the Psychophysiological Alterations in Traumatic Stress Subjects
Condition: Traumatic Stress, Post-Traumatic Growth
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): GDP
Intervention type(s): Behavioral
Intervention description(s): Guided Disclosure Protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Guided disclosure protocol; Post-traumatic growth; psycho-physiological alterations; Trauma Symptom Checklist; Sadaf Stress Scale