Protocol summary

Summary
Objectives: The main purpose of the study is to express the effectiveness of integrative behavior couple therapy in improving depression and couple distress of depressed couples. Design: The participants in the research were chosen non-randomly. Setting and conduct: They were chosen through purposive sampling between couples who referred to Tabriz helal ahmar. Participants including major eligibility criteria: Inclusion criteria are: Not using drugs and couples agreement for participating in research and exclusion criteria are: Having psychotic and personality disorder. Intervention: The sample research includes three couples having couple distress and one who has depression that is under treatment condition for 16 sessions. Instruments include beak questionnaire, couple questionnaire and frequency and acceptable of partner behavior. These questionnaires are done before treatment, between treatment and end of treatment. main outcome measures: The expected consequences of research will be reduction in depression symptoms, anxiety symptoms, frequency and acceptable of partner behavior and increase in commitment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013120115614N1
Registration date: 2014-04-17, 1393/01/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-04-17, 1393/01/28
Registrant information
Name
Zohreh Hashemi
Name of organization / entity
Tabtiz University
Country
Iran (Islamic Republic of)
Phone
+98 41 1385 7366
Email address
zohrehhashemi2010@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness Of Integrative Behavior Couple Therapy In Reducing The Siigns of couples depression
Public title
Effectiveness Of Couple Therapy In Reducing The Signs Of Couples Depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Not receiving psychological treatment before entering the study; In case of medication use؛ It should be possible to keep the type and dose of medication constant; During the study period; The patient should agree to participate in the study and sign consent. Exclusion criteria: Having a psychotic disorder and drug abuse; Having the full criteria for a personality disorder on Axis II; Risks for the patient like having serious thoughts about suicide; which make it impossible to stop medication or keep it constant.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 3
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

1

Registry name
ثبت نشده است
Secondary trial Id
ثبت نشده است
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz university ethics committee
Street address
29 Bahman Street, Tabriz University, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2013-09-09, 1392/06/18
Ethics committee reference number
12

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode

Primary outcomes

1

Description
Depression
Timepoint
Before treatment,During treatment, End of treatment, Follow up
Method of measurement
Beak Depression Inventory

Secondary outcomes

1

Description
Frequency of Partner Behavior
Timepoint
Before of Treatment, During Treatment, End of Treatment, Follow up
Method of measurement
Frequency and Acceptability of Partner Behavior Inventory

2

Description
Commitment
Timepoint
Before of Treatment, During Treatment, End of Treatment, Follow up
Method of measurement
Couple Questionnaire

3

Description
Anxiety
Timepoint
Before of treatment, During treatment, End of treatment, Follow up
Method of measurement
Beak Anxiety Inventory

4

Description
Marital conflict
Timepoint
Before of treatment, During treatment, End of tereatment, Follow up
Method of measurement
Marital conflict questionair

5

Description
Marital adjustment
Timepoint
Before of treatment, During treatment, End of treatment, Follow up
Method of measurement
Marital adjustment Questionnaire

Intervention groups

1

Description
Caseformulation, Acceptance intervention ( Tolerance technique, … ), Change techniques (behavior exchange, communication. problem-solving)
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Helal Ahmar, Ostad Shahriar clinic
Full name of responsible person
Mrs Gholizadeh
Street address
29 Bahmam Street, Helal Ahmar, Tabriz, Iran
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Tabriz, Vice chancellor for research
Full name of responsible person
Dr. Moghadam Vahed
Street address
Iran, Tabriz, Tabriz University, 29 Bahman street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Tabriz, Vice chancellor for research
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
Tabriz University
Full name of responsible person
Zohreh Hashemi
Position
Phd Student
Other areas of specialty/work
Street address
29 Bahman Street, Tabriz University, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1385 7366
Fax
Email
zohrehhashemi2010@yahoo,com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University
Full name of responsible person
Zohreh Hashemi
Position
Phd Student
Other areas of specialty/work
Street address
Iran, Tabriz, Tabriz University, 29 Bahman Street
City
Tabriz
Postal code
Phone
+98 41 1385 7366
Fax
Email
Zohrehhashemi2010@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University
Full name of responsible person
Zohreh Hashemi
Position
Phd Student
Other areas of specialty/work
Street address
Iran, Tabriz, Tabriz University, 29 Bahman Street
City
Tabriz
Postal code
Phone
+98 41 1385 7366
Fax
Email
Zohrehhashemi2010@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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