Protocol summary

Summary
Objective: The aim of this study was to investigate effectiveness of Emotionally focused group therapy (EFT) on improving emotional expressiveness and sexual function in women with type 2 diabetes. Design: Statistical population consisted of all women with type 2 diabetes that recruited through DaneshAmoz Health Center in Mashhad city in 2015. 24 women diagnosed with type 2 diabetes were chosen via available and judgmental sampling . Setting and conduct: It was used emotional expressiveness Questionnaire (EEQ) and Female sexual function Index (FSFI). 24 women diagnosed with type 2 diabetes were selected and and they were assigned randomly in to an experimental group and acontrol group. The treatment consisted of Emotionally focused group therapy (EFT) that consisted of eight 90-min weekly group sessions in each session and control group did not receive any treatment. After treatment, both groups were completed questionnaires. The intervention was performed on the Clinical Psychology and Counseling Center at the Ferdowsi University of Mashhad (Iran). Inclusion criteria: ages less 40 years, suffered from type 2 diabetics, had Diabetes for at least two years. Exclusion criteria: had severe somatic illness and psychiatric disorder, had Gestational Diabetes Mellitus, to use psychiatric drugs. The treatment consisted of Emotionally focused group therapy (EFT). Primary outcome variables are emotional expressiveness and sexual function.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017092036291N1
Registration date: 2017-10-08, 1396/07/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-08, 1396/07/16
Registrant information
Name
Bibi Somayyeh Ahmadi Bajestani
Name of organization / entity
Ferdowsi University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3880 5869
Email address
s.ahmadibajestani92@mail.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-08-06, 1394/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Emotion-focused group therapy on Emotional expressiveness and sexual functioning in women with type 2 diabetes
Public title
The effectiveness of Emotion-focused group therapy on improving Emotional expressiveness and sexual functioning in women with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ages less 40 years, suffered from type 2 diabetics, had Diabetes for at least two years. Exclusion criteria: had severe somatic illness and psychiatric disorder, had Gestational Diabetes Mellitus, use psychiatric drugs.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
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
Ethics committee of Ferdowsi University of Mashhad
Street address
faculty of pschology, Ferdowsi University of Mashhad, Azadi Sq, Mashhad
City
Mashhad
Postal code
Approval date
2015-05-12, 1394/02/22
Ethics committee reference number
3/37616

Health conditions studied

1

Description of health condition studied
type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Emotional expressiveness
Timepoint
before and after treatment
Method of measurement
Emotional Expressiveness Questionnaire (EEQ)

2

Description
sexual functioning
Timepoint
before and after treatment
Method of measurement
Female Sexual Function Index (FSFI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Emotionally focused group therapy treatment sessions comprised of eight 90min group session.Protocol consisted of Emotionally focused therapy protocol based on Susan Johnson (2004). Session-by-session outlines are presented. Session 1: introduction, making contact, create a therapeutic relationship; Session 2: Identification of the cycle of negative interactions and express forms of relational patterns for couples; Session 3: Discerning the underlying feeling or emotion; Session 4: Reframing the problems resulting from the cycle of negative interactions and attachment needs; Session 5: Having access to underlying fears and needs of attachment; Session 6 : Promotion of acceptance by the other spouse; Session 7: Smoothing the way for expression of needs and wants, and restructuring new models of interaction on the basis of new perceptions from each other and create ; Session 8: Providing new solutions for old challenges and Strengthening new positions and cycle of behavior and emotional.
Category
Behavior

2

Description
control group: Control group did not receive any treatment and after the initial eight-week delay, all those in the control group condition received the intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
DaneshAmooz Health Center
Full name of responsible person
Mrs Afghani
Street address
Diabetic part, DaneshAmooz Health Center, near intersection of DaneshAmooz and Farhang boulevard, Mashhad, Iran
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Ferdowsi University of Mashhad
Full name of responsible person
Dr Bahrami Ahmad
Street address
Vice president for research, Ferdowsi University of Mashhad , Azadi, Sq, Mashhad, Iran
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Ferdowsi University of Mashhad
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
Ferdowsi University of Mashhad
Full name of responsible person
BiBi Somayyeh Ahmadi Bajestani
Position
Master in family counseling
Other areas of specialty/work
Street address
faculty of education and psychology, Ferdowsi University of Mashhad, Azadi Sq, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 935 562 2716
Fax
Email
s.ahmadibajestani92@mail.um.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Dr Mohammad Javad Asghari EbrahimAbad
Position
phd
Other areas of specialty/work
Street address
Faculty of education and psychology, Ferdowsi University of Mashhad, Azadi Sq, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3880 5869
Fax
Email
mjasghari@um.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
BiBi Somayyeh Ahmadi Bajestani
Position
Master in family counseling
Other areas of specialty/work
Street address
faculty of education and psychology, Ferdowsi University of Mashhad, Azadi Sq, Mashhad, Iran
City
Mashhad
Postal code
Phone
00
Fax
Email
s.ahmadibajestani92@mail.um.ac.ir
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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