Protocol summary

Summary
Body Psychotherapy Techniques (BPT) is a program that teaches people how to deal more effectively with stressors. In the present study, we evaluate the effectiveness of body psychotherapy treatment on stress and salivary cortisol level in high school girls students. Materials and Methods: This Randomized clinical trials study with pre- post tests will be performed on 20 female students as case group and 20 participants serving as controls (15-18 years) in Gorgan, Iran . To determine stress, Cohen Stress Scale are administered at two points of measurement (before educational sessions and at the end of therapy), also their salivary samples collected directly after awakening as well as 15, 30, and 45 min later (the day before and after treatment). BPT group-education is given to the experimental group in nine sessions during two months. Data analysis is performed using SPSS software and unpaired t-test.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014053113776N2
Registration date: 2014-06-14, 1393/03/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-06-14, 1393/03/24
Registrant information
Name
Hossein Amini
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 1651
Email address
hamini@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Golstan Universty of Medical Sciences
Expected recruitment start date
2014-05-31, 1393/03/10
Expected recruitment end date
2014-07-07, 1393/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Body Psychotherapy Techniques (BPT) on stress and salivary cortisol level in High School Students in Gorgan
Public title
Body Psychotherapy Techniques (BPT) on stress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Healthy, female, student, High stress Exclusion: PMS syndrome, Menstural period
Age
From 15 years old to 18 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
tarbiat Modarres Uinversity
Street address
Jalal Ale Ahmad, Nasr bridge
City
Tehran
Postal code
5331-1411
Approval date
2014-05-26, 1393/03/05
Ethics committee reference number
d52/1554

Health conditions studied

1

Description of health condition studied
Stress
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
Stress
Timepoint
9 weeks
Method of measurement
Questionnaire

2

Description
Salivary cortisol
Timepoint
0, 15th, 30th and 45th minutes
Method of measurement
ELISA kit

Secondary outcomes

empty

Intervention groups

1

Description
Treatment group will receive educational sessions after pre-test of Cohn stress scale. Salivary cortisol samples will be collected pre and post educational sessions a brief description of sessions of body-psychotherapy is as follows: session1: empathy between therapist and clients, between clients, description of group rules by therapist, introduction to body-psychotherapy. Session2: introduction to body-psychotherapy, exploration of stressors and physiologic symptoms of stress in the body, providing information to increase awareness through body exercises, giving homework such as writing daily experience of body responses in stressful conditions. Session3: discussion about personal experience of group members, training breath practice to overcome stress and concentration on body, teaching how a person can communicate with ignored parts of body, giving homework. Session 4: performing breath practice, relaxation of stressful body organs, providing information regarding defense, avoidance, blocks and trauma on stress level, Training of radix and bioenergetics techniques, giving homework. Session5: exploration of blocks, avoidances, defenses and traumas by group members, evaluation of body emotions and their relations to avoidances, blocks, traumas, giving homework. Session 6: description of boundary between self and others, ability to feel yourself and others, teaching shiron and embodied relational therapy, giving homework. Session7: providing information regarding integrity of body and psyche, description of conscious control, teaching somatic and emotional therapy techniques, giving homework. Session 8: mindfulness regarding body sensations, emotions and memories, teaching Hakomi technique, giving homework. Session9: review of previous sessions, summary of sessions, performing post-test of Cohn stress scale and asking for collecting salivary cortisol in the next morning.
Category
Behavior

2

Description
For control group, we perform Cohn stress scale test as treatment group. Moreover, salivary cortisol will be collected at the same time schedule. Control group will not receive educational sessions.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Foroogh Danesh High school
Full name of responsible person
Street address
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Golestan university of medical Sciences
Full name of responsible person
Dr. Hossein Amini
Street address
Km 2 Sari Road, Shast Kola Road
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan university of medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tarbiat Modarress University
Full name of responsible person
Dr. Mohammad Javan
Position
Full Professor
Other areas of specialty/work
Street address
Jalal Ale Ahmad Nasr Bridge
City
Tehran
Postal code
Phone
+98 21 4483 0725
Fax
Email
mjavan@modares.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golstan Universty of Medical Sciences
Full name of responsible person
Dr. Hossein Amini
Position
PhD
Other areas of specialty/work
Street address
Shast Kola, Km 2 Sari
City
Gorgan
Postal code
Phone
+98 17 1552 5972
Fax
Email
haminhplc@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Golestan university of Medical Sciences
Full name of responsible person
Hossein Amini
Position
PhD, Scientific member of facualty of Medicine
Other areas of specialty/work
Street address
Hyrkan, Main Campus of Golestan University
City
Gorgan
Postal code
Phone
+98 17 1442 1289
Fax
Email
haminhplc@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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