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Comparision of the efficacy of pharmacotherapy and combination of pharmacotherapy with transdiagnostic cognitive-behavior therapy on anxiety and depression symptoms in patients with emotional disorders

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History
# Registration date Revision Id
2 2019-12-17, 1398/09/26 117796
1 2019-10-28, 1398/08/06 109218
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  • Protocol summary

    Determining the Effectiveness of Cognitive-Behavioral Cognitive-Behavioral Therapy with Drug Therapy Compared to Drug Therapy on Reduction of Symptoms of Anxiety and Depression in Patients with Emotional Disorders
    Determine the effectiveness of pharmacotherapy and combination of pharmacotherapy with transdiagnostic cognitive-behavior therapy on anxiety and depression symptoms in patients with emotional disorders

  • General information

    empty
    In the English title the name of the treatment was mistaken for the meta-cognitive meta-diagnosis.
    empty
    در عنوان انگلیسی نام درمان به جای فراتشخیصی فراشناختی اشتباه نوشته شده بود.
    Comparison of the efficacy of combination drug therapy and meta-cognitive-behavioral therapy on anxiety and depression symptoms in patients with emotional disorders
    Comparision of the efficacy of pharmacotherapy and combination of pharmacotherapy with transdiagnostic cognitive-behavior therapy on anxiety and depression symptoms in patients with emotional disorders
    Comparison of the efficacy of combination drug therapy and meta-cognitive-behavioral therapy on anxiety and depression symptoms in patients with emotional disorders
    Comparision of the efficacy of pharmacotherapy and combination of pharmacotherapy with transdiagnostic cognitive-behavior therapy on anxiety and depression symptoms in patients with emotional disorders

  • Recruitment centers

    #1
    Name of recruitment center - English: Ghods Hospital
    Name of recruitment center - Persian: بیمارستان قدس
    Full name of responsible person - English: Hamid Moetasemi
    Full name of responsible person - Persian: حمید معتصمی
    Street address - English: Keshavar St. Khanqah St. Alborz Golbarg Seven Plate 42
    Street address - Persian: خیابان کشاورز خیابان خانقاه کوچه گلبرگ هفت پلاک 42
    City - English: SANANADAJ
    City - Persian: سنندج
    Province: Kurdistan
    Country: Iran (Islamic Republic of)
    Postal code: 6619653814
    Phone: +98 87 3323 9922
    Fax:
    Email: pegahommati@yahoo.com
    Web page address:
    Name of recruitment center - English: Ghods Hospital
    Name of recruitment center - Persian: بیمارستان قدس
    Full name of responsible person - English: Hamid Moetasemi
    Full name of responsible person - Persian: حمید معتصمی
    Street address - English: Keshavar St. Khanqah St. Alborz Golbarg Seven Plate 42
    Street address - Persian: خیابان کشاورز خیابان خانقاه کوچه گلبرگ هفت پلاک 42
    City - English: Sanandaj
    City - Persian: سنندج
    Province: Kurdistan
    Country: Iran (Islamic Republic of)
    Postal code: 6619653814
    Phone: +98 87 3323 9922
    Fax:
    Email: pegahommati@yahoo.com
    Web page address:
    #2
    Name of recruitment center - English: Kurdistan Welfare Center
    Name of recruitment center - Persian: مرکز بهزیستی کردستان
    Full name of responsible person - English: Hamid Moetasemi
    Full name of responsible person - Persian: حمید معتصمی
    Street address - English: Keshavar St. Khanqah St. Alborz Golbarg Seven Plate 42
    Street address - Persian: خیابان کشاورز خیابان خانقاه کوچه گلبرگ هفت پلاک 42
    City - English: SANANDAJ
    City - Persian: سنندج
    Province: Kurdistan
    Country: Iran (Islamic Republic of)
    Postal code: 6619653814
    Phone: +98 87 3323 9922
    Fax:
    Email: pegahommati@yahoo.com
    Web page address:
    Name of recruitment center - English: Kurdistan Welfare Center
    Name of recruitment center - Persian: مرکز بهزیستی کردستان
    Full name of responsible person - English: Hamid Moetasemi
    Full name of responsible person - Persian: حمید معتصمی
    Street address - English: Keshavar St. Khanqah St. Alborz Golbarg Seven Plate 42
    Street address - Persian: خیابان کشاورز خیابان خانقاه کوچه گلبرگ هفت پلاک 42
    City - English: Sanandaj
    City - Persian: سنندج
    Province: Kurdistan
    Country: Iran (Islamic Republic of)
    Postal code: 6619653814
    Phone: +98 87 3323 9922
    Fax:
    Email: pegahommati@yahoo.com
    Web page address:
    #3
    Name of recruitment center - English: Kurdistan University Counseling Center
    Name of recruitment center - Persian: مرکز مشاوره دانشگاه کردستان
    Full name of responsible person - English: Ahmad Amani
    Full name of responsible person - Persian: احمد امانی
    Street address - English: Keshavar St. Khanqah St. Alborz Golbarg Seven Plate 42
    Street address - Persian: خیابان کشاورز خیابان خانقاه کوچه گلبرگ هفت پلاک 42
    City - English: SANANDAJ
    City - Persian: سنندج
    Province: Kurdistan
    Country: Iran (Islamic Republic of)
    Postal code: 6619653814
    Phone: +98 87 3323 9922
    Fax:
    Email: pegahommati@yahoo.com
    Web page address:
    Name of recruitment center - English: Kurdistan University Counseling Center
    Name of recruitment center - Persian: مرکز مشاوره دانشگاه کردستان
    Full name of responsible person - English: Ahmad Amani
    Full name of responsible person - Persian: احمد امانی
    Street address - English: Keshavar St. Khanqah St. Alborz Golbarg Seven Plate 42
    Street address - Persian: خیابان کشاورز خیابان خانقاه کوچه گلبرگ هفت پلاک 42
    City - English: Sanandaj
    City - Persian: سنندج
    Province: Kurdistan
    Country: Iran (Islamic Republic of)
    Postal code: 6619653814
    Phone: +98 87 3323 9922
    Fax:
    Email: pegahommati@yahoo.com
    Web page address:
    #4
    Name of recruitment center - English: Khanevadeh Clinic
    Name of recruitment center - Persian: کلینیک خانواده
    Full name of responsible person - English: َAsrin Seiedolshohadai
    Full name of responsible person - Persian: اسرین سیدالشهدایی
    Street address - English: Keshavar St. Khanqah St. Alborz Golbarg Seven Plate 42
    Street address - Persian: خیابان کشاورز خیابان خانقاه کوچه گلبرگ هفت پلاک 42
    City - English: SANANDAJ
    City - Persian: سنندج
    Province: Kurdistan
    Country: Iran (Islamic Republic of)
    Postal code: 6619653814
    Phone: +98 87 3323 9922
    Fax:
    Email: pegahommati@yahoo.com
    Web page address:
    Name of recruitment center - English: Khanevadeh Clinic
    Name of recruitment center - Persian: کلینیک خانواده
    Full name of responsible person - English: َAsrin Seiedolshohadai
    Full name of responsible person - Persian: اسرین سیدالشهدایی
    Street address - English: Keshavar St. Khanqah St. Alborz Golbarg Seven Plate 42
    Street address - Persian: خیابان کشاورز خیابان خانقاه کوچه گلبرگ هفت پلاک 42
    City - English: Sanandaj
    City - Persian: سنندج
    Province: Kurdistan
    Country: Iran (Islamic Republic of)
    Postal code: 6619653814
    Phone: +98 87 3323 9922
    Fax:
    Email: pegahommati@yahoo.com
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: The University of Kordestan
    Name of organization / entity - Persian: دانشگاه کردستان
    Full name of responsible person - English: mehdi zemestani
    Full name of responsible person - Persian: مهدی زمستانی
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Iran, Sanandaj, Pasdaran Boulevard, Kurdistan University
    Street address - Persian: ایران، سنندج، بلوار پاسداران، دانشگاه کردستان
    City - English: SANANDAJ
    City - Persian: سنندج
    Province: Kurdistan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6617715175
    Phone: 00968733664600_8 ((۲۲۴۶) داخلی)
    Mobile: +98 912 437 4452
    Fax:
    Email: m.zemestan@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: The University of Kordestan
    Name of organization / entity - Persian: دانشگاه کردستان
    Full name of responsible person - English: mehdi zemestani
    Full name of responsible person - Persian: مهدی زمستانی
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Kurdistan University, Pasdaran Boulevard, Sanandaj.Iran
    Street address - Persian: ایران، سنندج، بلوار پاسداران، دانشگاه کردستان
    City - English: SANANDAJ
    City - Persian: سنندج
    Province: Kurdistan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6617715175
    Phone: 00968733664600_8 ((۲۲۴۶) داخلی)
    Mobile: +98 912 437 4452
    Fax:
    Email: m.zemestan@gmail.com
    Web page address:

Protocol summary

Study aim
Determine the effectiveness of pharmacotherapy and combination of pharmacotherapy with transdiagnostic cognitive-behavior therapy on anxiety and depression symptoms in patients with emotional disorders
Design
Practical and semi-experimental data collection is pre-test, post-test and follow up with control group. Clinical trial with control group, not blind, sample selection available targeted. Experimental group was 14 and control group was 15
Settings and conduct
The treatment room of the Kurdistan University Meetings weekly for one hour for each client At each session, specific psychological techniques were practiced with clients at each session
Participants/Inclusion and exclusion criteria
The criteria for entering ، at least 18 years of age, male and female gender, diagnosis of anxiety disorder and depression. According to the psychiatrist, Sanandaj resident, No substance use, the willingness to participate and not receiving any therapeutic interventions, including psychological and Medication at least in the last year. Exclusion criteria, the occurrence of other psychiatric disorders, one and two, except emotional disturbances, the risk of suicide.
Intervention groups
The experimental group received the transdiagnostic treatment with the drug, which included eight sessions of 50 to 60 minutes per week. The control group received only medication.
Main outcome variables
anxiety and depression.

General information

Reason for update
In the English title the name of the treatment was mistaken for the meta-cognitive meta-diagnosis.
Acronym
IRCT registration information
IRCT registration number: IRCT20181019041385N1
Registration date: 2019-10-28, 1398/08/06
Registration timing: retrospective

Last update: 2020-01-12, 1398/10/22
Update count: 1
Registration date
2019-10-28, 1398/08/06
Registrant information
Name
Pegah Ommati
Name of organization / entity
The University of Kurdestan
Country
Iran (Islamic Republic of)
Phone
+98 87 3323 9922
Email address
pegahommati@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-11, 1397/08/20
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of the efficacy of pharmacotherapy and combination of pharmacotherapy with transdiagnostic cognitive-behavior therapy on anxiety and depression symptoms in patients with emotional disorders
Public title
Comparision of the efficacy of pharmacotherapy and combination of pharmacotherapy with transdiagnostic cognitive-behavior therapy on anxiety and depression symptoms in patients with emotional disorders
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Anxiety Disorder and Comorbid Depression (According to Psychiatrist) Sanandaj resident No history of substance abuse The desire to participate and not receive any therapeutic intervention, including psychological and medication, at least in the last year
Exclusion criteria:
Has personality disorders A history of suicide illiterate
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 29
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
www.iranduc.ir
Secondary trial Id
1426565
Registration date
2018-05-21, 1397/02/31

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of kurdestan
Street address
Keshavar St. Khanqah St. Alborz Golbarg Seven Plate 42
City
Sanandaj
Province
Kurdistan
Postal code
6619653814
Approval date
2019-07-29, 1398/05/07
Ethics committee reference number
IR.UOK.REC.1398.023

Health conditions studied

1

Description of health condition studied
Anxiety disorders and complex depression
ICD-10 code
F41.3
ICD-10 code description
Anxiety disorders and complex depression

Primary outcomes

1

Description
Anxiety
Timepoint
pre test, post test and follow up(one month after treatment)
Method of measurement
Beck Anxiety Inventory

2

Description
Depression
Timepoint
pre test, post test and follow up(one month after treatment)
Method of measurement
Beck Depression Inventory

Secondary outcomes

1

Description
emotional regulaition
Timepoint
Before and after 8 sessions of treatment
Method of measurement
Use the emotion regulation difficulty questionnaire

2

Description
Negative repetitive thoughts
Timepoint
Before and after 8 sessions of treatment
Method of measurement
Using Negative repetitive Thought Questionnaire

3

Description
Intolerance of Uncertainly
Timepoint
Before and after 8 sessions of treatment
Method of measurement
Use of uncertainty intolerance questionnaire

4

Description
Anxiety Sensitivity
Timepoint
Before and after 8 sessions of treatment
Method of measurement
Anxiety Sensitivity Questionnaire

5

Description
Experiential Avoidance
Timepoint
Before and after 8 sessions of treatment
Method of measurement
Experiential Avoidance Questionnaire

Intervention groups

1

Description
In the present study, participants were taking Anti-anxiety and antidepressant medication(Such as serotonin, Clonazepam, Buspirone, and venlafaxine) and also received eight sessions of transdiagnostic cognitive-behavioral therapy. Session 2: Psychological Training and Emotion Recognition. Session 3: Emotional Awareness Training.Session 4: Cognitive Assessment and Reassessment. Session 5: Emotional Avoidance (Behavior Understanding). Session 6: Emotional Behavior Behaviors (EDBs) Session 7: Exposure to Physical Sensations.
Category
Treatment - Other

2

Description
Control group: only anti-anxiety and anti-depressant drugs they consume.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghods Hospital
Full name of responsible person
Hamid Moetasemi
Street address
Keshavar St. Khanqah St. Alborz Golbarg Seven Plate 42
City
Sanandaj
Province
Kurdistan
Postal code
6619653814
Phone
+98 87 3323 9922
Email
pegahommati@yahoo.com

2

Recruitment center
Name of recruitment center
Kurdistan Welfare Center
Full name of responsible person
Hamid Moetasemi
Street address
Keshavar St. Khanqah St. Alborz Golbarg Seven Plate 42
City
Sanandaj
Province
Kurdistan
Postal code
6619653814
Phone
+98 87 3323 9922
Email
pegahommati@yahoo.com

3

Recruitment center
Name of recruitment center
Kurdistan University Counseling Center
Full name of responsible person
Ahmad Amani
Street address
Keshavar St. Khanqah St. Alborz Golbarg Seven Plate 42
City
Sanandaj
Province
Kurdistan
Postal code
6619653814
Phone
+98 87 3323 9922
Email
pegahommati@yahoo.com

4

Recruitment center
Name of recruitment center
Khanevadeh Clinic
Full name of responsible person
َAsrin Seiedolshohadai
Street address
Keshavar St. Khanqah St. Alborz Golbarg Seven Plate 42
City
Sanandaj
Province
Kurdistan
Postal code
6619653814
Phone
+98 87 3323 9922
Email
pegahommati@yahoo.com

5

Recruitment center
Name of recruitment center
Psychiatry office
Full name of responsible person
Farzin Rezaei
Street address
Keshavar St. Khanqah St. Alborz Golbarg Seven Plate 42
City
Sanandaj
Province
Kurdistan
Postal code
6619653814
Phone
+98 87 3323 9922
Email
pegahommati@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The university of kurdestan
Full name of responsible person
Mehdi Zemestani
Street address
No. 42, Keshavarz Ave., Khaneghah Ave.
City
Sanandaj
Province
Kurdistan
Postal code
6619653814
Phone
+98 87 3323 9922
Email
pegahommati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of kurdestan
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
the university of kurdestan
Full name of responsible person
mehdi zemestany
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Seven Plateau 42, Khaneghah Alley, Keshavarz Ave.
City
sanandaj
Province
Kurdistan
Postal code
6619653814
Phone
+98 87 3323 9922
Email
m.zemestan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Kordestan
Full name of responsible person
mehdi zemestani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kurdistan University, Pasdaran Boulevard, Sanandaj.Iran
City
SANANDAJ
Province
Kurdistan
Postal code
6617715175
Phone
00968733664600_8 ((۲۲۴۶) داخلی)
Email
m.zemestan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
the university of kurdestan
Full name of responsible person
pegah ommati
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Seven Plateau 42, Khaneghah Alley, Keshavarz Ave.
City
sanandaj
Province
Kurdistan
Postal code
6619653814
Phone
+98 87 3323 9922
Email
pegahommati@yahoo.com

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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data will be provided after it is completed.
When the data will become available and for how long
Information will be provided up to 5 months after the defense.
To whom data/document is available
Under the guidance of the supervisor, information will be provided.
Under which criteria data/document could be used
For the scientific use and promotion of knowledge.
From where data/document is obtainable
From the Supervisor Dr. Mehdi zemestany.
What processes are involved for a request to access data/document
Information will be provided up to 5 months after the defense.
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