Objectives: determine the efficacy of Unified Protocol and transdiagnostic mediator factors in reducing students’ anxiety and depression.Study design: Intervention, Random assignment to intervention group and control group, not blinded, without placebo. Method of the study: A) Study population: 350 Zanjan University of Medical Sciences students. Inclusion criteria: Residence in Zanjan while doing research; tending to participate in research and having the cut point in Beck Depression and Anxiety Tests. Exclusion criteria: having previous psychiatry problems; previous history of psychological interventions, especially cognitive-behavioral therapy, over 5 sessions of psychotherapy; missing more than two consecutive sessions in the unified protocol and not attending in one of the three evaluation stages. At first, a sample of 350 students was selected by Convenience Sampling and after initial screening based on the cut point of Beck Depression and Anxiety Tests 32 qualified students was selected and randomly and based on their homogeneity will be divided into two groups of 16 intervention and control. B) Intervention or interventions: In this study, Barlow unified protocol for transdiagnostic treatment will be used. C) Duration of intervention: It will take 6 months. 18 one-hour sessions. D) Initial outcomes and implications of the study: the efficacy of Unified Protocol and transdiagnostic mediator factors in reducing Zanjan University of Medical Sciences students’ anxiety and depression.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017072335245N1
Registration date:2017-09-02, 1396/06/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-02, 1396/06/11
Registrant information
Name
Sahel Khakpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0083
Email address
sahelkhakpoor@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zanjan University of Medical Sciences.
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Unified Protocol and transdiagnostic mediator factors in reducing students anxiety and depression
Public title
The efficacy of Unified Protocol in reducing students anxiety and depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Residence in Zanjan while doing research; tending to participate in research and having the cut point in Beck Depression and Anxiety Tests. Exclusion criteria: having previous psychiatry problems; previous history of psychological interventions, especially cognitive-behavioral therapy, over 5 sessions of psychotherapy; missing more than two consecutive sessions in the unified protocol and not attending in one of the three evaluation stages.
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
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
Zanjan University of Medical Sciences Ethics Committee
Street address
Zanjan University Of Medical Sience, Azadi Blvd
City
Zanjan
Postal code
Approval date
2017-08-11, 1396/05/20
Ethics committee reference number
ZUMS.REC.1396.143
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
2
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Anxiety
Timepoint
Pretest, Posttest and Fallow up after 2 month
Method of measurement
Beck Anxiety Inventory
2
Description
Depression
Timepoint
Pretest, Posttest and Fallow up after 2 month
Method of measurement
Beck Depression Inventory
Secondary outcomes
1
Description
Emotion regulation
Timepoint
Pretest, Posttest and Fallow up after 2 month
Method of measurement
Difficulties in Emotion Regulation Scale (DERS)
2
Description
Imbalance of uncertainty
Timepoint
Pretest, Posttest and Fallow up after 2 month
Method of measurement
Imbalance of uncertainty Scale (IUS-12)
3
Description
Avoid Experiences
Timepoint
Pretest, Posttest and Fallow up after 2 month
Method of measurement
Acceptance and action questionnaire - Second Edition (AAQ-2)
4
Description
Negative affection
Timepoint
Pretest, Posttest and Fallow up after 2 month
Method of measurement
Positive and Negative Affect Scale-Negative Affect (PANAS-NA)
5
Description
Perceived control
Timepoint
Pretest, Posttest and Fallow up after 2 month
Method of measurement
Perceived Control Questionnaire
6
Description
Occupational and social performance
Timepoint
Pretest, Posttest and Fallow up after 2 month
Method of measurement
Social-Job Adaptation Scale (WSAS)
Intervention groups
1
Description
Barlow unified protocol for transdiagnostic treatment will be used- 18 one-hour sessions on experimental group.
Category
Other
2
Description
No action was not subjected to the control group and intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan University of Medical Sciences
Full name of responsible person
Omid Saed (PhD)
Street address
Zanjan University of Medical Sciences, Azadi Blvd
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zanjan University of Medical Sciences
Full name of responsible person
Soghrat Faghihzade
Street address
Zanjan University of Medical Sciences, Azadi Blvd
City
Zanjan
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, Zanjan University of Medical Sciences
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
Zanjan University of Medical Sciences
Full name of responsible person
Omid Saed
Position
PhD
Other areas of specialty/work
Street address
Beheshti Hospital, Gate the Ark, Sadi Crossroad
City
Zanjan
Postal code
Phone
+98 242433424766
Fax
Email
o.saed@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Sahel Khakpoor Borazjani
Position
M.Sc.candidate in clinical psychology
Other areas of specialty/work
Street address
Beheshti Hospital, Gate the Ark, Sadi Crossroad.
City
Zanjan
Postal code
Phone
+98 242433424766
Fax
Email
sahelkhakpoor@zums.ac.ir; khakpoorsahel@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Sahel Khakpoor Borazjani
Position
M.Sc.candidate in clinical psychology
Other areas of specialty/work
Street address
Beheshti Hospital, Gate the Ark, Sadi Crossroad
City
Zanjan
Postal code
Phone
+98 242433424766
Fax
Email
sahelkhakpoor@zums.ac.ir; khakpoorsahel@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)