The Effectiveness of Unified Protocol for Transdiagnostic Treatment on Symptoms and Emotional and Cognitive indices of Adults with Separation Anxiety Disorder Comorbid with Emotional Disorders: A Randomized Controlled Trial
Investigate the effectiveness of unified protocol for transdiagnostic treatment on emotional and cognitive symptoms and indicators of adults with separation anxiety disorder comorbidity with emotional disorders
Design
The clinical trial has a wait-list group and an experimental group, which is double-blind and randomized using the minimization method.The sample size is 34 people.
Settings and conduct
Allocation of participants will be administered by someone other than a therapist. For the allocation of the participants, randomization minimization and a coin toss method method will be used. Referrals for the treatment and wait-list groups will be from the counseling center of the University of Kurdistan and mental health professionals.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having the diagnostic criteria for separation anxiety disorder and comorbid emotional disorders, consent to participate in the research, being at least 18 years old, Having at least a diploma, Speak Persian fluently, Ability to participate in all assessment and treatment sessions
Exclusion criteria: receiving any other type of psychological treatment, having any type of personality disorder and diagnosing any type of psychiatric disorder and diagnosing any type of psychiatric disorder (except for emotional disorders) and substance abuse and taking medication related to disorder and Having serious thoughts about Suicide
Intervention groups
The individuals suffering from adult separation anxiety disorder (ASA) with comorbid emotional disorders will randomly be assigned to two groups including UP and wait-list.
The treatment includes a maximum of 10 45-minute sessions that target emotional experiences.
Main outcome variables
Adult separation anxiety disorder; anxiety; cognitive fusion; anxiety sensitivity; difficulties in emotion regulation; intolerance of uncertainty
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240227061119N1
Registration date:2024-07-23, 1403/05/02
Registration timing:registered_while_recruiting
Last update:2024-07-23, 1403/05/02
Update count:0
Registration date
2024-07-23, 1403/05/02
Registrant information
Name
saeideh sobhani
Name of organization / entity
University of Kurdistan
Country
Iran (Islamic Republic of)
Phone
+98 31 4261 7092
Email address
saeideh.sobhani@uok.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-10, 1403/04/20
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Unified Protocol for Transdiagnostic Treatment on Symptoms and Emotional and Cognitive indices of Adults with Separation Anxiety Disorder Comorbid with Emotional Disorders: A Randomized Controlled Trial
Public title
The Effectiveness of Unified Protocol for Transdiagnostic Treatment on people with Separation Anxiety Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having the diagnostic criteria DSM-5-TR for separation anxiety disorder and comorbid emotional disorders, and not taking drugs related to disorder.
Consent to participate in the research
Being at least 18 years old
Having at least a diploma
Not receiving any type of treatment related to the disorder during the past year
Speak Persian fluently
Ability to participate in all assessment and treatment sessions
Exclusion criteria:
Receiving any other type of psychological treatment
Having any type of personality disorder and diagnosing any type of psychiatric disorder (except for emotional disorders)
Substance abuse
Having serious thoughts about Suicide
Taking medications related to disorders
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Participants with SAD and comorbid emotional disordes will assigne to treatment groups and wait- list group on the basis of covariate adaptive randomization (minimisation). The purpose of this method is to control gender variable. So if the first participant be female, she will assigne in group number one. When the second participant be a man, he will assigne in the first group. When the third participant be female, she will assigne to the second group. If the fourth participant be female, she will assigne to third group and then the rest of the participants will place in the groups by adjusting the gender variable.
Blinding (investigator's opinion)
Double blinded
Blinding description
Interviews will conduct by an expert clinical therapist to assess the inclusion and exclusion criteria. After that, individuals randomly will assign to treatment group and wait- list group. Allocation of participants, will administer by someone other than therapist.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in biological research
Street address
Central organization., University of Kurdistan., Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
15175-66177
Approval date
2024-04-27, 1403/02/08
Ethics committee reference number
IR.UOK.REC.1403.017
Health conditions studied
1
Description of health condition studied
Adult separation anxiety disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Separation anxiety score in adult separation anxiety questionnaire
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
Adult Separation Anxiety Questionnaire (ASA-27)
2
Description
Cognitive fusion score in cognitive fusion questionnaire
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
Cognitive fusion Questionnaire (CFQ)
3
Description
Anxiety sensitivity score in anxiety sensitivity questionnaire
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
Anxiety Sensitivity Questionnaire (ASI)
4
Description
Intolerance of uncertainty score in intolerance of uncertainty questionnaire
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
Intolerance Uncertainty Questionnaire (IUS)
5
Description
Emotion regulation score in the emotion regulation difficulty scale
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
Difficulties Emotion Regulation scale (DERS)
6
Description
Anxiety score in dass21 questionnaire
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
Dass21 questionnaire
7
Description
Depression score in dass21 questionnaire
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
Dass21 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: UP group. Unified protocol for transdiagnostic of emotional disorders consists of a maximum of 10, 45-minute individual treatment sessions. The UP targets and regulates emotional experiences by increasing emotion awareness and cognitive flexibility; identifying emotion-driven behaviors (EDBs) and replacing them with adaptive behaviors; identifying and preventing patterns of emotion avoidance; increasing awareness and confronting physical sensations, and facing emotions in situations. The treatment is preceded by enhancing the motivation and readiness of individuals for change and treatment engagement. Finally, the treatment ends by considering the progress of treatment and developing relapse prevention strategies.
Category
Treatment - Other
2
Description
Control group: wait-list group for Unified protocol.َAfter completion of follow-up sessions of intervention groups, the UP treatment will be applied as intervention group 1.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The University of Kurdestan
Full name of responsible person
Farzad Nasiri
Street address
University of Kurdistan., Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
15175-66177
Phone
+98 87 3366 4600
Email
f.nasiri@uok.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Kurdestan
Full name of responsible person
Ali Akbar Mozafari
Street address
University of Kurdistan., Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
15175-66177
Phone
+98 87 3362 7722
Email
a.mozafari@uok.ac.ir
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
Saeideh Sobhani
Position
MasterS Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 61, In front of Takhti Club., Nizam-ul-Mulk Ave., South Montazeri Ave
City
Najafabad
Province
Isfehan
Postal code
8517718844
Phone
+98 31 4261 7092
Email
saeideh.sobhani@uok.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Farzad Nasiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Kurdistan., Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Phone
087-33664601-2246
Fax
Email
f.nasiri@uok.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Saeideh Sobhani
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 61, Opposite Takhti Club., Nizam-ul-Mulk Ave., South Montazeri Ave
City
Najafabad
Province
Isfehan
Postal code
8517718844
Phone
+98 31 4261 7092
Fax
Email
saeideh.sobhani@uok.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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data including information about the main consequence can be shared.
When the data will become available and for how long
Start of accessibility will be one year after printing the results.
To whom data/document is available
Data will only be available to researchers working in academic institutions.
Under which criteria data/document could be used
Requests for data are only permitted for intercultural studies or the studies of meta-analysis.
From where data/document is obtainable
Researchers can use the mentioned communication channel to receive the desired documents or data. Email: f.nasiri@uok.ac.ir
What processes are involved for a request to access data/document
Data will be provided by email or post after evaluation of the request.