Comparing the effect of the transdiagnostic therapy based on emotion regulation with religious/spiritual design versus Barlow transdiagnostic therapy on symptoms and general function in women with anxiety disorders
the purpose of this study is Comparing the effect of the transdiagnostic Therapy Based on emotion regulation with Religious / Spiritual Design versus the Barlow's transdiagnostic Therapy on Symptoms and general function in Women with Anxiety Disorders.
Design
in this research, 10 eligible women with one of the anxiety disorders referring to Mehre Shefa health center in Yazd were chosen and were randomly divided into two groups of treatment.
Settings and conduct
This research is performed in the Mehre Shefa health Center in Yazd. The participants in the research are unaware about type of treatment they recieved.
Participants/Inclusion and exclusion criteria
Entrance conditions: Female gender; Age of 18-30 years; Minimum high school diploma education; principal diagnosis of anxiety disorder based on DSM-5; Full satisfaction for attending sessions.
Non-entrance Conditions: having Schizophrenia and other psychotic disorders; having Obsessive-compulsive disorder and related disorders; having Post traumatic stress disorder and related disorders; having Bipolar disorder and related disorders; having Substance and Alcohol abuse ; having substance/medication-induced anxiety disorder ; history of suicidal thoughts and attemps; taking medication or receiving psychotherapy during the last 6 months for the treatment of anxiety disorders.
Intervention groups
The two intervention groups consist of the transdiagnostic therapy based on emotion regulation with religious/spiritual design and Barlow's transdiagnostic therapy. Each treatment includes 12 one- hour sessions , which performed individually.
in this study, no control group was used.
Main outcome variables
general symptoms of anxiety; General symptoms of depression; General function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180104038214N1
Registration date:2018-08-08, 1397/05/17
Registration timing:retrospective
Last update:2018-08-08, 1397/05/17
Update count:0
Registration date
2018-08-08, 1397/05/17
Registrant information
Name
roghaye sadat mirjalili
Name of organization / entity
Tarbiat modares university
Country
Iran (Islamic Republic of)
Phone
+98 35 3521 1663
Email address
ra.mirjalili@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-09, 1396/10/19
Expected recruitment end date
2018-02-08, 1396/11/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of the transdiagnostic therapy based on emotion regulation with religious/spiritual design versus Barlow transdiagnostic therapy on symptoms and general function in women with anxiety disorders
Public title
Comparing the effect of two transdiagnostic therapy on symptoms of anxiety disorders
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Female sex
Age 18-30 years
Have at least high school diploma
Having one of the anxiety disorders based on DSM-5
Having full satisfaction to participate in sessions
Exclusion criteria:
Having schizophrenia and other psychotic disorders
Having Obsessive-compulsive disorder and related disorders
Having Post traumatic stress disorder and related disorders
Having Bipolar mood disorder and related disorders
Having substance and alcohol abuse
Having substance/medication-induced anxiety disorder
Having a history of suicidal thoughts and actions
taking medication or receiving psychotherapy during the past 6 months for the treatment of anxiety disorders
lack of religious adherence
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple randomization through lottery
Random unit: Individual
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 comittee of Iran University of Medical Sciences
before intervention, Sessions 3, 6, 9,12 of therapy and one-month and three-month follow-up
Method of measurement
Beck anxiety disorder, adult version of Screen for Child Anxiety Related Emotional Disorders (SCARED-A), generalized anxiety disorder scale- 7(GAD-7)
2
Description
general function
Timepoint
before intervention, Sessions 6, 12 of therapy and one-month and three-month follow-up
Method of measurement
Work and Social Adjustment Scale (WSAS)
Secondary outcomes
1
Description
depression status
Timepoint
2 stages in baseline, sessions 3, 6, 9, 12 and one-months and three-months follow-up
Method of measurement
beck depression inventory (BDI)
Intervention groups
1
Description
first Intervention group: transdiagnostic therapy based on emotion regulation with religious / spiritual design. The treatment protocol includes 12 one-hour session which run weekly and for three months. The titles of the sessions are, respectively, 1.the preparation for the treatment and enhance motivation of client, 2. understanding emotions in the balanced system of human, 3. introducing the role of cognition in regulating and modifying emotions to client, 4. identifying and modifying the god-images of client, 5. adapting the cognitive evaluations of client with god concept, 6. identifying the world- images of client and modifying them, 7. identifying the hereafter- images of client and modifying them, 8. behavioral self-caring, 9. awareness of physical feelings and reinforcement tolerance of them, 10.directing awareness to god, 11. Intrinsic and situation-based emotional exposure 12. relapse prevention
Category
N/A
2
Description
second Intervention group: Barlow transdiagnostic therapy. This intervention includes 8 modules, each module taking between one or two sessions. Modules include: 1. Increasing the motivation for participate in treatment, 2. Psychological training and seeking emotional experience, 3. Mindfulness-based emotional awareness, 4. Cognitive flexibility, 5. emotional avoidance and emotional behaviors, 6. awareness and tolerance of physical feelings, 7. Intrinsic and situation-based emotional exposure, 8. Prevention of relapse. sessions lengthen from 8 to 12 sessions and between approximately 50 to 60 minutes. sessions are held on a weekly basis.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Tarbiat Modares university
Full name of responsible person
Roghaye Sadat Mirjalili
Position
Ph.D student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
NO. 67 , Kargar ave, Yadavaran Blvd, Shahedie town
City
Yazd
Province
Yazd
Postal code
8943114386
Phone
+98 35 3521 1663
Fax
Email
ra.mirjalili@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares university
Full name of responsible person
Roghaye Sadat Mirjalili
Position
Ph.D student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
NO. 67 , Kargar ave, Yadavaran Blvd, Shahedie town
City
YAZD
Province
Yazd
Postal code
8943114386
Phone
+98 35 3521 1663
Fax
Email
ra.mirjalili@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares university
Full name of responsible person
Roghaye Sadat Mirjalili
Position
Ph.D student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
NO. 67 , Kargar ave, Yadavaran Blvd, Shahedie town
City
YAZD
Province
Yazd
Postal code
8943114386
Phone
+98 35 3521 1663
Fax
Email
ra.mirjalili@modares.ac.ir
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is publishable after unrecognizing people.
Designed protocol of transdiagnostic therapy based on emotion regulation with religious / spiritual design is Shareable.
The data analysis plan includes visual charts in single case studies, and statistical indicators of Improvement percentages and effect sizes.
When the data will become available and for how long
6 months after the publication of results
To whom data/document is available
academic reasherchers
Under which criteria data/document could be used
treatment protocol can be used to evaluate its efficacy in other clinical groups and to compare its efficacy with other therapeutic protocols.
From where data/document is obtainable
roghaye sadat mirjalili
mirjalili.r14@gmail.com
What processes are involved for a request to access data/document
The applicant must send an email in order to receive files and the documents and a request files will be sent for a maximum of two weeks.