To Observe the Psychophysiological Alterations in Traumatic Stress Subjects

NCT04217863 | Completed DMC

• 1 other identifier: KU-Psychophysiology-5
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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).

Conditions

Traumatic Stress, Post-Traumatic Growth

Keywords

Guided disclosure protocol; Post-traumatic growth; psycho-physiological alterations; Trauma Symptom Checklist; Sadaf Stress Scale

Outcome Measures

Primary Outcomes (1)

• Post-Traumatic Growth (PTG)

  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

Secondary Outcomes (8)

• C- Reactive Protein (CRP)

  3 Months

• Brain-derived neurotrophic factor (BDNF)

  3 Months

• Interleukin-6 (IL-6)

  3 Months

• Glutamate

  3 Months

• Cortisol

  3 Months

Other Outcomes (2)

• Trauma Symptom Checklist 40 (TSC-40)

  3 Months

• Traumatic Stress Scale (Sadaf Stress Scale)

  3 Months

Study Arms (2)

The experimental intervention (GDP): It includes three writing

EXPERIMENTAL

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

The control intervention:

NO 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.

Interventions

GDP BEHAVIORAL

Guided Disclosure Protocol

The experimental intervention (GDP): It includes three writing

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Karachi: lead
• Advanced Education & Research Center: collaborator

Study Sites (1)

Shamoon Noushad

Karachi, Sindh, 78500, Pakistan

Location

Related Publications (8)

• Gandubert C, Scali J, Ancelin ML, Carriere I, Dupuy AM, Bagnolini G, Ritchie K, Sebanne M, Martrille L, Baccino E, Hermes A, Attal J, Chaudieu I. Biological and psychological predictors of posttraumatic stress disorder onset and chronicity. A one-year prospective study. Neurobiol Stress. 2016 Feb 4;3:61-67. doi: 10.1016/j.ynstr.2016.02.002. eCollection 2016 Jun.

  PMID: 27981178 BACKGROUND

• Kalisch R, Muller MB, Tuscher O. A conceptual framework for the neurobiological study of resilience. Behav Brain Sci. 2015;38:e92. doi: 10.1017/S0140525X1400082X. Epub 2014 Aug 27.

  PMID: 25158686 BACKGROUND

• Cai WP, Pan Y, Zhang SM, Wei C, Dong W, Deng GH. Relationship between cognitive emotion regulation, social support, resilience and acute stress responses in Chinese soldiers: Exploring multiple mediation model. Psychiatry Res. 2017 Oct;256:71-78. doi: 10.1016/j.psychres.2017.06.018. Epub 2017 Jun 8.

  PMID: 28624675 BACKGROUND

• Liu AN, Wang LL, Li HP, Gong J, Liu XH. Correlation Between Posttraumatic Growth and Posttraumatic Stress Disorder Symptoms Based on Pearson Correlation Coefficient: A Meta-Analysis. J Nerv Ment Dis. 2017 May;205(5):380-389. doi: 10.1097/NMD.0000000000000605.

  PMID: 27875386 BACKGROUND

• Linz R, Puhlmann LMC, Apostolakou F, Mantzou E, Papassotiriou I, Chrousos GP, Engert V, Singer T. Acute psychosocial stress increases serum BDNF levels: an antagonistic relation to cortisol but no group differences after mental training. Neuropsychopharmacology. 2019 Sep;44(10):1797-1804. doi: 10.1038/s41386-019-0391-y. Epub 2019 Apr 16.

  PMID: 30991416 BACKGROUND

• Alper B, Erdogan B, Erdogan MO, Bozan K, Can M. Associations of Trauma Severity with Mean Platelet Volume and Levels of Systemic Inflammatory Markers (IL1beta, IL6, TNFalpha, and CRP). Mediators Inflamm. 2016;2016:9894716. doi: 10.1155/2016/9894716. Epub 2016 Apr 5.

  PMID: 27127347 BACKGROUND

• Smith HE, Jones CJ, Hankins M, Field A, Theadom A, Bowskill R, Horne R, Frew AJ. The effects of expressive writing on lung function, quality of life, medication use, and symptoms in adults with asthma: a randomized controlled trial. Psychosom Med. 2015 May;77(4):429-37. doi: 10.1097/PSY.0000000000000166.

  PMID: 25939030 BACKGROUND

• Gidron Y, Duncan E, Lazar A, Biderman A, Tandeter H, Shvartzman P. Effects of guided written disclosure of stressful experiences on clinic visits and symptoms in frequent clinic attenders. Fam Pract. 2002 Apr;19(2):161-6. doi: 10.1093/fampra/19.2.161.

  PMID: 11906981 BACKGROUND

MeSH Terms

Interventions

Guanosine Diphosphate

Intervention Hierarchy (Ancestors)

Guanine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 24, 2019
• First Posted: January 6, 2020
• Study Start: December 2, 2019
• Primary Completion: August 10, 2021
• Study Completion: August 10, 2021
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)