Protocol summary

Summary
The goal of this clinical tail is to determine the impact of group schema therapy on depression, anxiety and stress in patients with insulin-dependent diabetes.Among all the diabetic patients referred to Yusuj Clinic University of Medical Sciences, 64 patients with insulin-dependent diabetes will be selected and according to the questionnaire (DASS-42) who has moderate to severe depression, anxiety and stress will be enrolled in this study.This means after the introduction of the researcher, explaining the objectives of the study and how research will be done, informed consent is obtained, then questionnaires such as demographic, depression, anxiety and stress (DASS-42) (1995) and the short form of the Young Schema 75 items (SQ-SE) (1994) will give to the subjects that after their completion randomly allocated to two groups of subjects and control.After ensuring consistency between the two groups, the treatment process for intervention group will take place during 10 sessions of 90 minutes over a period of 5 weeks. During this meetings we will use techniques of schema therapy such as imagery, experimental techniques, providing a list of supporting evidence Schema, assessing the advantages and disadvantages of coping styles, Empty chair technique to establish a dialogue between the " Healthy aspect" and " Schema aspects ",schema educational card, while a control group will not receive interventions considered in this study except routine services till taking the post test. Also, after a month of completion of the training, the above questionnaire completed by both groups will be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015102124620N6
Registration date: 2016-02-02, 1394/11/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-02, 1394/11/13
Registrant information
Name
Azadeh Eghbalmanesh
Name of organization / entity
Yasuj university of Medical Sciense
Country
Iran (Islamic Republic of)
Phone
+98 74 3334 6978
Email address
eghbalimanesh.azadeh@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasuj University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of group schema therapy on depression, anxiety and stress in patients with insulin-dependent diabetes
Public title
Schema therapy in in patients with insulin-dependent diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion citeria: hearing ability and acceptable speech; lack of depression and anexiety according to diagnostic criteria of DSM-IV; wiliingness to participate in study; diagnosis of moderate to severe depression (score 14-28); moderate to severe anxiety (score 10 -27); moderate to severe stress (score 14-34) after filling out the questionnaire DASS-42; no use of psychiatric drugs from 4 months ago till now; having a history of diabetes more than a year; having a history of suicide attempts and substance abuse and alcohol; at least having a cycle. Exclusion criteria: cognitive disorders and mental illness after beginning of the study; having a defect that seriously hamper the patients to participate in group therapy; failure to participate in three sessions of Schema Therapy; participating in other group psychotherapy at the same time; death and emigration of the patients.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
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

1

Registry name
Yasuj University of Medical Science
Secondary trial Id
yums.REC.1394.70
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd.
City
Yasuj
Postal code
Approval date
2015-09-09, 1394/06/18
Ethics committee reference number
yums.REC.1394.70

Health conditions studied

1

Description of health condition studied
Schemathereapy in patients with insulin-dependent diabetes
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Depression
Timepoint
At the begining of the study, last session of group schematherapy of intervention and one month after group schematherapy intervention
Method of measurement
Quesstionnare dass-42(1996)

2

Description
Anexiety
Timepoint
At the begining of the study, last session of group schematherapy of intervention and one month after group schematherapy intervention
Method of measurement
Quesstionnare DASS-42(1996)

3

Description
Primary malladaptive schemas
Timepoint
At the begining of the study, last session of group schematherapy of intervention and one month after group schematherapy intervention
Method of measurement
Young Schema Questionnaire-Short Form 75-item (SE-SQ) (1994)

4

Description
Stress
Timepoint
At the begining of the study, last session of group schematherapy of intervention and one month after group schematherapy intervention
Method of measurement
Quesstionnare DASS-42(1996)

Secondary outcomes

empty

Intervention groups

1

Description
subjects in experimental group will have group schematherapy including : imagery, experimental techniques, providing a list of supporting evidence Schema, Assessing the advantages and disadvantages of coping styles, Empty chair technique to establish a dialogue between the " Healthy aspect" and " Schema aspects ",schema educational card during 10 sessions of 90 minutes over a period of 5 weeks.
Category
Behavior

2

Description
A control group will not receive interventions considered in this study (group schematherapy) except routine services till taking the post test.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Yasuj Clinical University of Medical Scincevs Clinic (Shahid Mofateh)
Full name of responsible person
Street address
City
Yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Dr. Mehdi Akbartabar Turi
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd.
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasuj 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
Yasuj University of Medical Sciences
Full name of responsible person
Dr. Mohammad Zoladl
Position
Psychiatric Nursing Ph.D/ Associate Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shahid Dr. Jalil St.
City
Yasuj
Postal code
Phone
+98 74 3323 5141
Fax
Email
zoladl.mohammad@yums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Dr. Mohammad Zoladl
Position
Psychiatric Nursing Ph.D/ Associate Professor.
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shahid Dr. Jalil St.
City
Yasuj
Postal code
Phone
+98 74 3323 5141
Fax
Email
zoladl.mohammad@yums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Azadeh Eghbalmanesh
Position
MA student of psychiateric nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shahid Dr. Jalil St.
City
Yasuj
Postal code
Phone
+98 74 3334 6978
Fax
Email
eghbalimanesh.Azadeh@yums.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
Loading...