The Comparison Of Efficacy Of Face-To-Face Unified Transdiagnostic Therapy With Internet-Based Unified Transdiagnostic Therapy In Reducing Symptoms And Improving The Function Of Adolescents With Depressive And Anxiety Disorders
1- Comparison of the effectiveness of unified face-to-face transdiagnostic treatment with unified Internet-based transdiagnostic treatment in reducing the symptoms of emotional disturbance in adolescents with anxiety and depressive disorders.
2. Comparison of the effectiveness of unified face-to-face and Internet-based transdiagnostic treatment in improving the functioning of adolescents with anxiety and depressive disorders.
Design
Clinical trial with control group, with parallel, randomized groups, on 45 patients. The "Random Allocation Law" method will be used for randomization.
Settings and conduct
First, based on a structured clinical interview by a clinical psychologist and psychiatrist, 45 people with one or more of the anxiety or depressive disorders (based on DSM5) were referred to a psychiatric clinic, hospital psychiatric clinics, or school counselors in the cities of Tehran, Karaj and Rasht have been selected and patients who have responded to the therapist's online call will be selected. Sampling will be purposeful and individuals will be assigned to 3 groups of face-to-face treatment, Internet-based treatment and control, 15 people in each group, after meeting the criteria for entering the research and the absence of criteria for leaving the research. People will be assigned in three groups at random.
Participants/Inclusion and exclusion criteria
patients with anxiety and depressive disorders.
Intervention groups
1- Unified face-to-face transdiagnostic treatment group: the group that receives face-to-face protocol of Ehrenreich et al.
2. Internet-based unified transdiagnostic treatment: the group that receives the unified treatment through a website (researcher-made).
3. Control group: the group that does not receive treatment at the same time as the two experimental groups.
Main outcome variables
Improve function, reduce the symptoms of anxiety and depressive disorders.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220226054129N1
Registration date:2022-03-05, 1400/12/14
Registration timing:prospective
Last update:2022-03-05, 1400/12/14
Update count:0
Registration date
2022-03-05, 1400/12/14
Registrant information
Name
Nasim Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8850 8048
Email address
nas.mousavi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison Of Efficacy Of Face-To-Face Unified Transdiagnostic Therapy With Internet-Based Unified Transdiagnostic Therapy In Reducing Symptoms And Improving The Function Of Adolescents With Depressive And Anxiety Disorders
Public title
The Comparison of Face-To-Face Unified Transdiagnostic Therapy with Internet-Based Unified Transdiagnostic Therapy in Adolescents with Depressive and Anxiety Disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The diagnosis and the main problem of the person, based on the clinical interview by a clinical psychologist or psychiatrist, is a mood or anxiety disorder (combination of psychiatric problems including conduct disorders, attention deficit-hyperactivity disorder, eating disorders, non-interfering with treatment drug abuse, are acceptable, if the main problem is anxiety or depression).
The person has not had CBT treatment for anxiety or depression in the past.
Age between 12 and 18 years.
If the person is taking medication, a stable dose has been reached and it is necessary that this stable dose be obtained for SSRIs three months before the start of treatment and for benzodiazepines one month before the start of treatment.
Access to high speed internet at home.
Exclusion criteria:
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, the method of "random allocation law" will be used for randomization. The researcher prepares 15 balls for group A, 15 balls for group B and 15 balls for group C and places them all in the lottery container. The balls are then randomly removed from the container without replacement and the sequence created is recorded.
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 University of Social welfare and rehabilitation sciences
Street address
No. 9, P. 24, Pakzadnia Alley, West Mirzaee Zeynali Ave., North Sohrevardi Ave.
City
Tehran
Province
Tehran
Postal code
1576977619
Approval date
2020-09-12, 1399/06/22
Ethics committee reference number
IR.USWR.REC.1399.167
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F30
ICD-10 code description
Major depressive disorder, recurrent
2
Description of health condition studied
Persistent mood disorders
ICD-10 code
F34
ICD-10 code description
Persistent mood [affective] disorders
3
Description of health condition studied
Phobic anxiety disorders
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
4
Description of health condition studied
Other anxiety disorders
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
Primary outcomes
1
Description
The primary outcome is depression and is measured using the RCADS (Revised Child Anxiety and Depression Scale).
Timepoint
The beginning of the intervention, the end of the intervention, three months after the end of the intervention.
Method of measurement
RCADS (Revised Child Anxiety and Depression Scale)
2
Description
The primary outcome is anxiety and is measured using the RCADS (Revised Child Anxiety and Depression Scale).
Timepoint
The beginning of the intervention, the end of the intervention, three months after the end of the intervention
Method of measurement
RCADS (Revised Child Anxiety and Depression Scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants in the first group will receive treatment face to face. Treatment sessions will be individual, and unified transdiagnostic treatment will be conducted in eleven 45-minute sessions weekly. Unified transdiagnostic treatment of adolescent emotional disorders refers to the Ehrenreich May et al. (2017) protocol. The unified protocol consists of four main parts, which are: increasing emotional awareness, facilitating flexibility in assessments, identifying and preventing behavioral and emotional avoidance, and situational and internal exposure to emotion clues.
Category
Treatment - Other
2
Description
Intervention group: People in the second group will receive treatment based on the Internet and through a website. This treatment is also designed based on unified protocol of transdiagnostic treatment of emotional disorders for adolescence.
Category
Treatment - Other
3
Description
Control group: During this period, no intervention will be performed for the control group, but after the end of the treatment time, the members of the control group will also be treated.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Nezam Mafi Clinic
Full name of responsible person
Nasim Mousavi
Street address
Near Nezam Mafi Mosque, After Jannatabad, Ayatollah Kashani BLV.
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 4402 3114
Email
nasim.moosavi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. Masoud Fallahi Khoshkenab
Street address
University of Social Welfare and Rehabilitation, Kudakyar Alley, Daneshju Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2822
Email
rd@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
10
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamid Poursharifi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Social Welfare and Rehabilitation, Kudakyar Alley, Daneshju Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0045
Email
poursharifih@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Nasim Mousavi
Position
Ph. D. Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 24, Pakzadnia Alley, West Mirzaee zeynali Ave., north Sohrevardi Ave.
City
Tehran
Province
Tehran
Postal code
1576977619
Phone
+98 21 8850 8048
Fax
Email
nas.mousavi@uswr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Nasim Mousavi
Position
Ph. D. Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 24, Pakzadnia Alley, West Mirzaee zeynali Ave., north Sohrevardi Ave.
City
Tehran
Province
Tehran
Postal code
1576977619
Phone
+98 21 8850 8048
Fax
Email
nas.mousavi@uswr.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available