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To Observe the Psychophysiological Alterations in Traumatic Stress Subjects

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ClinicalTrials.gov Identifier: NCT04217863
Recruitment Status : Enrolling by invitation
First Posted : January 6, 2020
Last Update Posted : January 6, 2020
Sponsor:
Collaborator:
Advanced Education & Research Center
Information provided by (Responsible Party):
Shamoon Noushad, University of Karachi

Brief 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).

Condition or disease Intervention/treatment Phase
Traumatic Stress, Post-Traumatic Growth Behavioral: GDP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Effects of the Guided Disclosure Protocol on Post-Traumatic Growth: A Randomized Control Trial Designed to Observe Psychophysiological Alterations in Traumatic Stress Subjects
Actual Study Start Date : December 2, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : August 1, 2020

Arm Intervention/treatment
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.
Behavioral: GDP
Guided Disclosure Protocol

No Intervention: 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.



Primary Outcome Measures :
  1. Post-Traumatic Growth (PTG) [ Time Frame: 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.


Secondary Outcome Measures :
  1. C- Reactive Protein (CRP) [ Time Frame: 3 Months ]
    Change in the CRP level will be observed among the subjects enrolled in the GDP group as compared to the control group.

  2. Brain-derived neurotrophic factor (BDNF) [ Time Frame: 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. Interleukin-6 (IL-6) [ Time Frame: 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.

  4. Glutamate [ Time Frame: 3 Months ]
    Change in the Glutamate level will be observed among the subjects enrolled in the GDP group as compared to the control group.

  5. Cortisol [ Time Frame: 3 Months ]
    Change in the Cortisol level will be observed among the subjects enrolled in the GDP group as compared to the control group.

  6. Alpha waves [ Time Frame: 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.

  7. Heart Rate Variability [ Time Frame: 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.

  8. Beta waves [ Time Frame: 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.


Other Outcome Measures:
  1. Trauma Symptom Checklist 40 (TSC-40) [ Time Frame: 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.

  2. Traumatic Stress Scale (Sadaf Stress Scale) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217863


Locations
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Pakistan
Shamoon Noushad
Karachi, Sindh, Pakistan, 78500
Sponsors and Collaborators
University of Karachi
Advanced Education & Research Center
Publications:

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Responsible Party: Shamoon Noushad, Principal Investigator, University of Karachi
ClinicalTrials.gov Identifier: NCT04217863    
Other Study ID Numbers: KU-Psychophysiology-5
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shamoon Noushad, University of Karachi:
Guided disclosure protocol
Post-traumatic growth
psycho-physiological alterations
Trauma Symptom Checklist
Sadaf Stress Scale