1. Home
  2. Approved trials
  3. » فارسی

The comparison of efficacy of primary transdiagnostic protocol based on repetitive negative thinking with Barlow transdiagnostic protocol (2011) in symptoms reduction of people with co-occurrence anxiety and depression disorders.

Protocol summary

Summary
(1) Objectives: A) To determine pilot efficacy of primary transdiagnostic protocol based on repetitive negative thinking on three person with co-occurrence anxiety and depression disorders; B) To compare efficacy of primary transdiagnostic protocol based on repetitive negative thinking with Barlow transdiagnostic protocol (2011) in symptoms reduction of patients with co-occurrence anxiety and depression disorders. (2) Design: General plan of this study is consisted of experimental pre-test and post-test with control group and follow-up period. (3) Setting and conduct: In the beginning, primary transdiagnostic protocol based on repetitive negative thinking was designed. Then, in order to pilot efficacy of primary protocol, it will be carried out on three patients with co-occurrence anxiety and depression disorders. After pilot study, samples will be selected then they will be randomly assigned to research groups. Assessment of the tools used in research will be performed by a trained assessor other than the researcher in three steps of before treatment, at the end of treatment, and after a 2-month follow-up. At the end, desired treatments will be individually carried out on research sample. (4) Participants: The research sample is consisted of 45 patients with co-occurrence anxiety and depression disorders that will be selected from undergraduate students referred to counseling and psychological services center of Sharif University. They will be randomly assigned to three experimental and control group. (15 participants in experimental group 1, 15 participants in experimental group 2 and 15 peoples in control group or wait-list group). (5) Intervention: The first intervention is consisted of 12 sessions (each session is 45 minutes in a week) of transdiagnostic therapy based on repetitive negative thinking for experimental group 1. The second intervention is consisted of 12 sessions (each session is 45 minutes in a week) of Barlow transdiagnostic protocol (2011) for experimental group 2. (6) Main outcome measures: main outcome measures variables in this research are anxiety, depression, repetitive negative thinking, emotional dysregulation, metacognitive beliefs and experiential avoidance.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013090414564N1
Registration date: 2013-12-29, 1392/10/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-12-29, 1392/10/08
Registrant information
Name
Mehdi Akbari
Name of organization / entity
Kharazmi University
Country
Iran (Islamic Republic of)
Phone
+98 21 6602 1735
Email address
akbari.psy@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahed University
Expected recruitment start date
2013-11-11, 1392/08/20
Expected recruitment end date
2014-01-10, 1392/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of efficacy of primary transdiagnostic protocol based on repetitive negative thinking with Barlow transdiagnostic protocol (2011) in symptoms reduction of people with co-occurrence anxiety and depression disorders.
Public title
The comparison of efficacy of primary transdiagnostic protocol based on repetitive negative thinking with Barlow transdiagnostic protocol in symptoms reduction of people with co-occurrence anxiety and depression disorders.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: Having diagnostic criteria more than one co-occurrence anxiety and depression disorders based on structural clinical interview for axis I; Undergraduate student; Patient consent for participate in research; The availability of the patient during treatment and follow-up period; Stable on the same dose if use psychotropic medications. Exclusion criteria: Having any kind of psychosis disorder; Having bipolar mood disorder (type I or II); Having any kind of severe personality disorder; The history of drug abuse; giving another psychological treatment, such as cognitive behavior therapy, behavior therapy, cognitive therapy or group therapy simultaneous with treatment or in past; Having serious problem in during the study such as suicidal thoughts or change in rates of psychotropic medications dose.
Age
From 18 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 45
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 Shahed University
Street address
Shahed University, Tehran- Gom freeway, Opposite Holy Shrine of Imam Komeini, Tehran, Iran
City
Tehran
Postal code
33191​18651
Approval date
2013-11-11, 1392/08/20
Ethics committee reference number
41/185117

Health conditions studied

1

Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

2

Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder

3

Description of health condition studied
Post-traumatic stress disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder

4

Description of health condition studied
Social phobia disorder
ICD-10 code
F40.1
ICD-10 code description
Social phobia disorder

5

Description of health condition studied
Panic disorder
ICD-10 code
F41.0
ICD-10 code description
Panic disorder

6

Description of health condition studied
Major depressive disorder
ICD-10 code
F33
ICD-10 code description
Recurrent depressive disorder

Primary outcomes

1

Description
Repetitive negative thinking
Timepoint
Before treatment, at the end of treatment, and after a 2-month follow-up
Method of measurement
Repetitive Negative Thinking Questionnaire

2

Description
Anxiety
Timepoint
Before treatment, at the end of treatment, and after a 2-month follow-up
Method of measurement
Depression Anxiety Stress Scale-21

3

Description
Depression
Timepoint
Before treatment, at the end of treatment, and after a 2-month follow-up
Method of measurement
Depression Anxiety Stress Scale-21

4

Description
Emotional dysregulation
Timepoint
Before treatment, at the end of treatment, and after a 2-month follow-up
Method of measurement
Difficulties in Emotion Regulation Scale

5

Description
Metacognition beliefs
Timepoint
Before treatment, at the end of treatment, and after a 2-month follow-up
Method of measurement
Metacognition Beliefs Questionnaire

6

Description
Experiential avoidance
Timepoint
Before treatment, at the end of treatment, and after a 2-month follow-up
Method of measurement
The Multidimensional Experiential Avoidance Questionnaire

Secondary outcomes

1

Description
General function
Timepoint
Before treatment, at the end of treatment, and after a 2-month follow-up
Method of measurement
Work and Social Adjustment Scale

Intervention groups

1

Description
The first intervention is consisted of 12 sessions (each session is 45 minutes in a week) of transdiagnostic therapy based on repetitive negative thinking for experimental group 1.
Category
Behavior

2

Description
The second intervention is consisted of 12 sessions (each session is 45 minutes in a week) of Barlow transdiagnostic therapy (2011) for experimental group 2.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Counseling and Psychological Services Center of Sharif University
Full name of responsible person
Mitra Aghajani
Street address
Counseling and Psychological Services Center, Sharif University, Azadi Street, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahed University
Full name of responsible person
Dr.kiasalari
Street address
Shahed University, Tehran- Gom freeway, Opposite Holy Shrine of Imam Komeini, Tehran, Iran
City
Tehran
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, Shahed University
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
Shahed University
Full name of responsible person
Mehdi Akbari
Position
Doctoral Candidate in Clinical Psychology
Other areas of specialty/work
Street address
Shahed University, Tehran- Gom freeway, Opposite Holy Shrine of Imam Komeini, Tehran, Iran
City
Tehran
Postal code
33191​18651
Phone
+98 21 6602 1735
Fax
Email
Akbari.psy@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mehdi Akbari
Position
Doctoral Candidate in Clinical Psychology
Other areas of specialty/work
Street address
Shahed University, Tehran- Gom freeway, Opposite Holy Shrine of Imam Komeini, Tehran, Iran
City
Tehran
Postal code
33191​18651
Phone
+98 21 6602 1735
Fax
Email
Akbari.psy@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mehdi Akbari
Position
Doctoral Candidate in Clinical Psychology
Other areas of specialty/work
Street address
Shahed University, Tehran- Gom freeway, Opposite Holy Shrine of Imam Komeini, Tehran, Iran
City
Tehran
Postal code
33191​18651
Phone
+98 21 6602 1735
Fax
Email
Akbari.psy@gmail.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
Loading...