Cognitive, emotional and neuropsychological indices of generalized anxiety disorder: effectiveness of unified transdiagnostic treatment with and without transcranial direct current stimulation
The aim of the current study is to compare unified protocol for transdiagnostic treatment of emotional disorders with and without tDCS in individuals suffering from generalized anxiety disorder (GAD) and comorbid depression.
Design
Participants with GAD and comorbid depression will assign to treatment groups and waitlist group on the basis of covariate adaptive randomization (minimization). The purpose of this method will control the gender variable.
Settings and conduct
Allocation of participants will administer by someone other than a therapist. For allocation of the participants, a roll of a die will use. Referrals for the treatment and wait-list groups will from the counseling center of the Ferdowsi University of Mashhad and mental health professionals.
Participants/Inclusion and exclusion criteria
The study population will include people with GAD and comorbid depression in Mashhad in 2018. The sample of research also will include a number of people with GAD with depression.
Intervention groups
The individuals suffering from GAD with comorbid depression will randomly assign in three groups including UP with tDCS, UP without tDCS and wait-list
Main outcome variables
Cognitive fusion; intolerance of uncertainty; cognitive avoidance; difficulties in emotion regulation; cognitive emotion regulation; anxiety sensitivity; cognitive flexibility; working memory; inhibition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140929019334N1
Registration date:2019-01-08, 1397/10/18
Registration timing:retrospective
Last update:2019-01-08, 1397/10/18
Update count:0
Registration date
2019-01-08, 1397/10/18
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3522 3173
Email address
nasiri@stu.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-09, 1396/09/18
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
2017-11-22, 1396/09/01
Actual recruitment end date
2018-06-22, 1397/04/01
Trial completion date
2018-08-11, 1397/05/20
Scientific title
Cognitive, emotional and neuropsychological indices of generalized anxiety disorder: effectiveness of unified transdiagnostic treatment with and without transcranial direct current stimulation
Public title
Effectiveness of unified transdiagnostic treatment with and without transcranial direct current stimulation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnostic DSM-V criteria for GAD as the primary diagnosis and depression disorder as a comorbid disorder
If the drug was taken, it was possible to maintain the type and amount of the drug during the study period
Be a minimum 18 years and a maximum 40 years old
Patient's consent to participate in research and to sign written consent
Speak Persian fluently
Ability to participate in all assessment and treatment sessions
Exclusion criteria:
Need for immediate medical treatment or the need for concurrent therapeutic interventions in such a way as to interfere with the treatment program
Not having previous experience in at least eight sessions of treatment based on the cognitive-behavioural therapy in the last 5 years
Having psychiatric disorders and substance abuse
Current diagnosis of any mental disorder in the axes I and II, with the exception of GAD and depression
Patient's opposition to collaboration at any time of research
Having serious thoughts about Suicide
History of experiencing other psychological treatments
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
45
Actual sample size reached:
43
Randomization (investigator's opinion)
Randomized
Randomization description
Participants with GAD and comorbid depression 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)
Single 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 groups (UP group and UP-tDCS 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 Bioresearch
Street address
Azadi Square., campus of Ferdowsi university of Mashhad., Central organization
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Approval date
2018-12-26, 1397/10/05
Ethics committee reference number
IR MUM FUM REC .1397.047
Health conditions studied
1
Description of health condition studied
Generalized anxiety disorder comorbid with depression
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Score of generalized anxiety from GAD-Q-IV questionnaire
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
GAD-Q-IV questionnaire
2
Description
Score of depression from Beck depression questionnaire
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
Beck depression questionnaire
Secondary outcomes
1
Description
Score of worry from PSWQ
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
PSWQ questionnaire
2
Description
Score of intolerance of uncertainty from IUS
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
IUS questionnaire
3
Description
Score of cognitive fusion from CFQ
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
CFQ questionnaire
4
Description
Score of cognitive avoidance from CAQ
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
CAQ questionnaire
5
Description
Score of difficulties in emotion regulation from DERS
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
DERS questionnare
6
Description
Score of cognitive emotion regulation from CERQ
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
CERQ questionnaire
7
Description
Score of emotion regulation from ERQ
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
ERQ questionnaire
8
Description
Score of anxiety sensitivity from ASI
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
ASI questionnaire
9
Description
Score of cognitive flexibility from Wisconsin test
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
Wisconsin card sorting test
10
Description
Score of inhibition from go/no go test
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
Go/no go software
11
Description
Score of working memory from n-back test
Timepoint
Pre-treatment; post-treatment; follow-up
Method of measurement
N- back software
Intervention groups
1
Description
Intervention group: group 1: UP group. Unified protocol for transdiagnostic of emotional disorders consists of a maximum of 12, 60-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 with physical sensations, and facing with emotions in situations. The treatment is preceded by enhancing 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.2:UP-tDCS. In the UP-tDCS group, for two weeks until the end of the UP sessions, the tDCS will perform. The treatment consists of 10 daily sessions (except for weekends) with a direct current of 2.0 mA for 30-minute stimulation session. The 25 cm2 rubber electrodes will moistene with saline to reduce impedance. The cathode will place over the right dorsolateral prefrontal cortex (DLPFC).
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
Counselling center of Ferdowsi University of Mashhad
Full name of responsible person
Zahra Tabibi
Street address
Vakilabad Blvd; Ferdowsi University of Mashhad; Counselling center of University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 6914
Email
tabibi@um.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Ahmad Reza Bahrami
Street address
Vakilabad Blvd; Ferdowsi university of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 2420
Email
pr@um.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ferdowsi University of Mashhad
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
Ferdowsi University of Mashhad
Full name of responsible person
Farzad Nasiri
Position
Ph.D. candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Vakilabad Blvd; Ferdowsi University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 985138806914
Fax
Email
nasiri@mail.um.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Farzad Nasiri
Position
Ph.D. candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Vakilabad Blvd; Ferdowsi University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 985138806914
Fax
Email
nasiri@mail.um.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Farzad Nasiri
Position
Ph.D. candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Vakilabad Blvd; Ferdowsi University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 985138806914
Fax
Email
nasiri@mail.um.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.