The effectiveness of transdiagnostic cognitive behavioral therapy of worry, rumination and negative metacognitive beliefs in people with generalized anxiety symptoms
The effectiveness of transdiagnostic cognitive behavioral therapy on worry, rumination and negative metacognitive beliefs
In people with generalized anxiety symptoms
Design
Clinical trial with a control group, with parallel groups, double-blind, non-randomized, experimental group on 15 patients out of 30 total sample size
Settings and conduct
Study place, Hakim Tous Higher Education Institute. Intervention method: Transdiagnostic cognitive-behavioral therapy is performed according to Barlow's treatment protocol. Treatment method: The experimental group will receive transdiagnostic therapy for 3 months in 12 sessions, once a week for 90 minutes. The study is a double-blind type (participants, researcher, as well as study outcome evaluators) will be unaware of the allocation of study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Obtaining a score above 10 in the generalized anxiety disorder questionnaire 2. Age at least 20 years old 3. Conscious desire and sufficient motivation to participate and continue the treatment
Exclusion criteria: 1. The presence of any Axis 1 disorder except generalized anxiety disorder 2. The presence of psychotic symptoms or special physical diseases 3. Unwillingness to continue treatment
Intervention groups
The experimental group consists of 15 patients with general anxiety symptoms undergoing extradiagnostic treatment, the control group consists of 15 people who did not receive a high score in anxiety and do not receive any intervention, and as a result of the treatment, the results of the two groups will be compared.
Main outcome variables
Obtaining an anxiety score (score above 10) in the pervasive anxiety questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240709062376N1
Registration date:2024-08-01, 1403/05/11
Registration timing:prospective
Last update:2024-08-01, 1403/05/11
Update count:0
Registration date
2024-08-01, 1403/05/11
Registrant information
Name
Samane Zavar
Name of organization / entity
Hakim Toos Institute of Higher Education
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 2726
Email address
s.zavvar@hakimtoos.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-15, 1403/05/25
Expected recruitment end date
2024-09-15, 1403/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of transdiagnostic cognitive behavioral therapy of worry, rumination and negative metacognitive beliefs in people with generalized anxiety symptoms
Public title
The effectiveness of transdiagnostic cognitive behavioral therapy in people with generalized anxiety symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Getting a score above 10 in the generalized anxiety disorder questionnaire
Age at least 20 years old
Diploma and above
Not taking anti-anxiety and psychotherapy drugs in the last 6 months
Willingness, informed consent and sufficient motivation to participate and continue the treatment
Exclusion criteria:
The presence of any axis 1 disorder except generalized anxiety disorder
Existence of psychotic symptoms or special physical diseases
Report any attempts or even thoughts of committing suicide at any time during the study
Existence of a history of drug abuse and addiction at present and recently.
Dissatisfaction and desire to leave treatment
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding will be possible at the level of researchers and outcome assessors, but not at the level of participants. The control group does not receive any level of the independent variable and any treatment. This group is used because it is determined at the end whether the treatment had a significant effect on the experimental group. People who are randomly assigned to the experimental group will receive transdiagnostic cognitive behavioral therapy. Data from both groups are collected and compared to each other to determine whether the treatment was effective.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Razavi Khorasan, Mashhad ,university street , Hakim Toos Institute of Higher Education
City
Mashhad
Province
Razavi Khorasan
Postal code
91388144165
Approval date
2024-06-22, 1403/04/02
Ethics committee reference number
IR.MUMS.REC.1403.111
Health conditions studied
1
Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
The anxiety score obtained in the generalized anxiety questionnaire
Timepoint
Pre-test (measurement of anxiety level 1 month before the start of the study)Post-test (measuring the level of anxiety after completing the study)Follow-up (4 months after completion of treatment)
Method of measurement
It is the score that a person gets in the Generalized Anxiety Disorder Questionnaire (GAD-7) (2006).
Secondary outcomes
empty
Intervention groups
1
Description
In this study, there is only one treatment (transdiagnostic cognitive behavioral therapy). This treatment is only done on the experimental group and the control group does not receive any treatment. This group is used because it is determined at the end whether the treatment had a significant effect on the experimental group. The experimental group and the control group are equalized and homogenized in terms of all the studied variables. Also, before the statistical analysis, the research variables are equalized in both groups. The total sample size of the current research is 30 people who are divided into two groups of 15 people. After completing the questionnaire, 15 people with generalized anxiety symptoms are selected based on the entry criteria. To diagnose generalized anxiety, Spitzer's Generalized Anxiety Questionnaire is used, Penn State and Barlow questionnaires are used to measure worry, Nalen, Hoeksma, and Maro questionnaires are used to measure rumination, and Wells Questionnaire is used to measure negative metacognitive beliefs. Protocol Briefly, the intervention includes: 1-Increasing motivation 2-Providing psychological training 3-Emotional awareness training 4-Cognitive re-evaluation 5-Identifying avoidance patterns 6-ADBS examination of behaviors caused by emotion 7-Awareness and tolerance of physical feelings 8- Facing corresponding emotions B. Position 9- Prevention of relapse. The experimental group will receive meta-diagnostic treatment during 3 months in 12 sessions, once a week for 90 minutes. Data from both groups are collected and compared to each other to determine whether the treatment was effective. It is possible that after the completion of the work, due to ethical considerations and the effectiveness of the treatment, the intervention will be done on the control group with the consent of the people.
Category
Treatment - Other
2
Description
Control group: 15 of the people whose score in the anxiety questionnaire is below the cut-off line and do not receive the diagnosis of anxiety will not receive any intervention. After the study is completed, the results of the experimental group will be compared with this group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Counseling and Lifestyle Center of Hakim Toos Institute of Higher Education
Full name of responsible person
Samane Zavvar
Street address
Mashhad . university street, University Street 19 ,Number 230
City
Mashhad
Province
Razavi Khorasan
Postal code
9138814416
Phone
+98 51 3840 2726
Fax
+98 51 3840 9363
Email
info@hakimtoos.ac.ir
Web page address
https://hakimtoos.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hakim Toos Institute of Higher Education
Full name of responsible person
Saeeda Behroznia
Street address
Mashhad، university street ،University Street 19، Number 230
City
Mashhad
Province
Razavi Khorasan
Postal code
9138814416
Phone
+98 51 3840 2726
Fax
+98 51 3840 9363
Email
info@hakimtoos.ac.ir
Web page address
https://hakimtoos.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hakim Toos Institute of Higher Education
Proportion provided by this source
100
Public or private sector
Private
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
Hakim Toos Institute of Higher Education
Full name of responsible person
Samane Zavar
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mashhad,Khiyaban daneshgah,Danshgah19,no 230
City
Mashhad
Province
Razavi Khorasan
Postal code
9138814416
Phone
+98 51 3840 2726
Fax
+98 51 3840 9363
Email
s.zavvar@hakimtoos.ac.ir
Web page address
https://hakimtoos.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hakim Toos Institute of Higher Education
Full name of responsible person
Samane Zavar
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mashhad,Khiyaban daneshgah,Danshgah19,NO 230
City
Mashhad
Province
Razavi Khorasan
Postal code
9138814416
Phone
+98 51 3840 2726
Fax
+98 51 3840 9363
Email
s.zavvar@hakimtoos.ac.ir
Web page address
https://hakimtoos.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Hakim Toos Institute of Higher Education
Full name of responsible person
Samane Zavar
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mashhad,Khiyaban daneshgah,Danshgah19,NO 230
City
Mashhad
Province
Razavi Khorasan
Postal code
9138814416
Phone
+98 51 3840 2726
Fax
+98 51 3840 9363
Email
s.zavvar@hakimtoos.ac.ir
Web page address
https://hakimtoos.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD