determining Effectiveness of the Group Acceptance Based Behavior Therapy in Generalized Anxiety Disorder in Patients with Episodic Migraine
Design
randomized control trial with control group, single blind
Sample size is calculated based on G-POWER (20 participant each group)
Settings and conduct
The intervention will be done in a neurologist private clinic and will be in 16 group sessions.
Outcome assessment in groups is done by a third person and the researcher and statistical analyst will not know about it.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Have diagnostic criteria for episodic migraine based on Neurologist based on IHCD-II criteria; Having diagnostic criteria for generalized anxiety disorder according to SCID-5; Being at least 18 years old; Minimum diploma education.
exclusion criteria:
Symptoms of psychosis; Bipolar disorder; substance-related and addictive disorders based on SCID-5; Get other psychological treatments at the same time; Having the thoughts of suicide outright now; Having a debilitating physical condition or a serious medical condition; Have diagnostic criteria for; tension headache based on Neurologist based on IHCD-III criteria
Intervention groups
Group Acceptance Based Behavior Therapy
Control group receiving only drug therapy
It should be noted that in order to prevent drug interference, the current drug treatment of patients is kept constant and, if they take prophylactic medication, it is kept constant from 1 month before the intervention until the end of the follow-up period. But the use of painkillers as a variable will be examined in the study
Main outcome variables
severity of Generalized Anxiety Disorder;
severity of headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190926044891N1
Registration date:2020-02-01, 1398/11/12
Registration timing:registered_while_recruiting
Last update:2020-02-01, 1398/11/12
Update count:0
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
Fateme Veisy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 5516 5560
Email address
veisy.f@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of the Group Acceptance Based Behavior Therapy in Generalized Anxiety Disorder in Patient with Episodic Migraine
Public title
Group Acceptance Based Behavior Therapy in Generalized Anxiety Disorder in Patient with Episodic Migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Recurrent episodic migraine diagnoses based on IHCD-III criteria by neuroscientists
Having a diagnosis of generalized anxiety disorder based on DSM-5
Minimum diploma education
Exclusion criteria:
Psychotic disorder basted on DSM-5
Bipolar disorder based on DSM-5
Substance related and addictive disorder based on DSM-5
Get other psychological treatments at the same time
Having suicidal thoughts now
Having a debilitating physical condition or a serious medical condition
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
For random assignment, randomization is blocked randomization with fixed block sizes. The size of the blocked is 4. Randomization was performed using https://www.sealedenvelope.com/.
Blinding (investigator's opinion)
Single blinded
Blinding description
Unawareness of the researcher and statistical analyst of the personal code in the intervention and treatment groups
Performing assessments by another person
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran Univercity of medical scince ethics committee
Patients with Episodic Migraine comorbid with Generalized Anxiety Disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
severity of GAD
Timepoint
Before intervention, End of intervention and 3 months later for follow up
Method of measurement
Generalized Anxiety Disorder-7 questionnaire
Secondary outcomes
1
Description
headache severity
Timepoint
Before intervention, End of intervention and 3 months later for follow up
Method of measurement
Patients report their headaches every day from 0 to 10, and at the end, the average headache severity is reached
Intervention groups
1
Description
Intervention group: The ABBT, which offers 16 sessions of psychotherapy, is based on the ABBT protocol, which details the structure of the meeting session by session. Duration of one to four sessions are 90 minutes, and session five to sixteen are 60 minutes.It should be noted that if consent is obtained for this study, drug treatment will be maintained for 1 month before the intervention until the end of the follow-up period. Patients will be excluded if the medication needs to be changed.
Category
Treatment - Other
2
Description
Control group: if consent is obtained for this study, drug treatment will be maintained for 1 month before the intervention until the end of the follow-up period. Patients will be excluded if the medication needs to be changed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Mansoure Togha clinic
Full name of responsible person
Dr Mansoure Togha
Street address
N0 1, 24 street, Ghaem Magham Farahani Ave
City
Teharan
Province
Tehran
Postal code
1586984411
Phone
+98 21 8832 8351
Email
toghae@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr seyed Abas Motevalian
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Web page address
http://iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?