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The Effectiveness of Integrative psychotherapy on Body Image, Self-esteem and Sexual Function in Patients with systemic sclerosis (Scleroderma)

Protocol summary

Study aim
Designing and determining the effectiveness of integrated therapy with the orientation of four common factors in reducing Body Image anxiety, increasing self-esteem and sexual function in patients with scleroderma. Determination of sustainability The effectiveness of integrated therapy with four common factors over time, on Body Image anxiety, self-esteem and sexual function variables in patients with scleroderma.
Design
In this study, 30 patients with systematic scleroderma (with entry requirements) are selected from the rheumatology department of Shariati Hospital in Tehran (Iran). patients are randomly divided into two control and intervention groups and a code are allocated to each one of them.
Settings and conduct
The Integrated Psychotherapy protocol is presented as group sessions for the intervention group at the Iranian Rheumatism Center (Tehran). The therapist is aware of the intervention, but the participants in the intervention and control group are unaware of the psychotherapy process.
Participants/Inclusion and exclusion criteria
All patients resident on Tehran with scleroderma, whose records have been recorded in the department of rheumatology of Shariati Hospital, one year have passed since their diagnosis, have not any psychiatric disorders and have not used any psychoactive drugs during the past three months. Complete the informed consent form for participation in the research.
Intervention groups
In this study, the design and evaluation of the effectiveness of integrated therapy based on the model of four common factors (therapeutic relationship, hope and expectation of treatment, awareness and behavioral ordering) on ​​reducing image body anxiety, increasing self-esteem and increasing sexual function in Scleroderma patients are treated. At first, dependent variables are evaluated by pre-test questionnaires that have valid and validated validity in both groups. Then, in group, the experimental group is under the intervention of psychotherapy, but the control group is expected during the research. After the intervention and evaluation of the experimental and control groups and the completion of the post-test and follow-up questionnaire, psychiatric intervention will also be implemented for the control group (due to ethical relations and, if desired).
Main outcome variables
Reduce of worry from body image ; Increase of self-esteem; Increase of sexual function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171125037622N1
Registration date: 2017-12-16, 1396/09/25
Registration timing: registered_while_recruiting

Last update: 2017-12-16, 1396/09/25
Update count: 0
Registration date
2017-12-16, 1396/09/25
Registrant information
Name
Layla Shamkoeyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8807 0642
Email address
l.shamkoeyan@kiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-06, 1396/09/15
Expected recruitment end date
2017-12-31, 1396/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Integrative psychotherapy on Body Image, Self-esteem and Sexual Function in Patients with systemic sclerosis (Scleroderma)
Public title
The Effectiveness of Integrative psychotherapy on Patients with Scleroderma
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All patients whose information is recorded in the Department of Rheumatology of the Shariati Hospital (based on the American College of Rheumatology package or formerly the American Rheumatism Association). At least one year has passed from diagnosing scleroderma. Residents in Tehran and its surroundings Complete the aware and voluntary consent form for participation in the research
Exclusion criteria:
Patients should not be afflicted with mental disorders (in accordance with DSM V). Do not have a history of taking psychoactive drugs over the past 3 months. Patients who have had three absences due to the nature of the illness during the intervention sessions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
At first, available patients are selected and then randomly assigned (using sealed envelopes) to the two groups of test and control, and the individual randomization unit.
Blinding (investigator's opinion)
Single blinded
Blinding description
Single-blind study is just for the participants, and since psychological intervention is directly taught by the researcher also the evaluation and control operations are conducted by him, the researcher is aware of the method of study.
Placebo
Used
Assignment
Parallel
Other design features
The design of a unified protocol for educational and psychotherapy based on a four-factor common model for patients with scleroderma.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of islamic azad univercity, karaj branch
Street address
Rajai Shahr، Moazzen Boulevard
City
Karaj
Province
Alborz
Postal code
3148635731
Approval date
2017-10-31, 1396/08/09
Ethics committee reference number
IR.IAU.K.REC.1396,54

Health conditions studied

1

Description of health condition studied
systemic sclerosis (Scleroderma)
ICD-10 code
M34
ICD-10 code description
Systemic sclerosis [scleroderma]

Primary outcomes

1

Description
Body image worry score in Littleton's body image worry questionnaire.
Timepoint
To measure the effectiveness of unified therapy psychotherapy on the amount of body image anxiety, we measure the amount of body image anxiety before the intervention (pre test), after the intervention (post test) and one month after the last day of the intervention (follow up)
Method of measurement
To investigate the effect of integrated psychotherapy on body image anxiety, we use the Littleton's Physical Image Worry Questionnaire.

2

Description
Self-esteem score in Cooper Smith self-esteem questionnaire.
Timepoint
To evaluate the efficacy of integrated therapy for self-esteem, We measure the amount of self-esteem before the intervention (pre-test), after the intervention (post-test) and one month after the last day of the intervention (follow up).
Method of measurement
To investigate the effect of integrated psychotherapy on self-esteem, we use the Cooper Smith self-esteem questionnaire.

3

Description
Sexual Function Score in female Sexual Function Index (FSFI).
Timepoint
To evaluate the efficacy of integrated therapy for sexual performance, We measure the amount of sexual function before the intervention (pre -test) , after the intervention (post-test) and one month after the last day of the intervention (follow up).
Method of measurement
Function Index Female Sexual and International Index of Erectile Function

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Hoda kavosi
Street address
North Kargar St. Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 84901
Email
h-kavosi@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Reza Ezati
Street address
Rajai Shahr, Moazzen Boulevard
City
Karaj
Province
Alborz
Postal code
3148635731
Phone
+98 26 3418 2738
Email
ezati@kiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Layla Shamkoeyan
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 19,. Hasan Sayf. 20., Hasan Sayf Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1466746581
Phone
+98 21 8807 0642
Email
l.shamkoeyan@kiau.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farah Lotfi Kashani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
PO Box: 189, Roudehen, Tehran
City
Roudehen
Province
Tehran
Postal code
۳۹۷۳۱۸۸۹۸۱
Phone
+98 21 8830 5686
Email
lotfikashani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Layla Shamkoeyan
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.19 , Hasn Sayf 20 Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1466746581
Phone
+98 21 8807 0642
Fax
Email
L.SHAMKOEYAN@Kiau.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after unidentifiable people.
When the data will become available and for how long
Since 2018/04
To whom data/document is available
Researchers and practitioners in the field of mental and physical health
Under which criteria data/document could be used
For scientific and research use of students, professors and researchers is permitted.
From where data/document is obtainable
Referring to the library of Islamic Azad University, Karaj Branch; Sending a message to a private mail; l.shamkoeyan@gmail.com
What processes are involved for a request to access data/document
Send a message to your personal and e-mail and Answer during 5 days
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