Forty six women with generalized anxiety disorder who were referred from psychiatrics offices in Isfahan city were recruited to participate in the study. They were then administered the Structural Clinical Interview for DSM-IV – Clinician Version (SCID/CV). Thirty nine subjects who met the criteria for GAD and were able to complete the program were randomly assigned to three groups (Acceptance Based Behavior Therapy, Applied Relaxation and the control group). All of the groups received medication. The Acceptance Based Behavior Therapy and Applied Relaxation also participated in 12 weekly therapy sessions. The instruments used in the study included the Generalized Anxiety Disorder-7 item scale (GAD-7), Valued Living Questionnaire, Action and Acceptance Questionnaire, Penn State Worry Questionnaire (PSWQ) and Short Form Health Survey -12 revised version (SF-12V2).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108057227N1
Registration date:2012-06-25, 1391/04/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-25, 1391/04/05
Registrant information
Name
Fatemeh Zargar
Name of organization / entity
Tehran Psychiatric Institute, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 8748
Email address
f.zargar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-11-21, 1390/08/30
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Acceptance-Based Behavior Therapy and Applied Relaxation in the Treatment of female with Generalized Anxiety Disorder
Public title
The Effect of Acceptance-Based Behavior Therapy in the Treatment of Generalized Anxiety Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Statistical population included female patients with generalized anxiety disorder who referred to psychiatrist offices in Isfahan city. 35 women Patients with generalized anxiety disorder diagnosis selected if they met the following criteria: (1) primary diagnosis of generalized anxiety disorder; (2) requesting treatment for theirgeneralized anxiety disorder; (3) older than 18 and younger than 60 years; (4) no psychotherapy received for their generalized anxiety disorder; (5) no evidence of mental retardation, psychotic disorders, alcohol or drug dependence.
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mental Health Research Center
Street address
Tehran, Niayesh Ave, Rasool hospital
City
Tehran
Postal code
Approval date
2011-08-02, 1390/05/11
Ethics committee reference number
728/130/د/90
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
Generalized anxiety disorder
Timepoint
Before and after intervention
Method of measurement
GAD-7
2
Description
Worry
Timepoint
Before and after intervention
Method of measurement
Penn State Worry Questionnaire (PSWQ)
3
Description
Engagement in valued actions
Timepoint
Before and after intervention
Method of measurement
Valued Living Questionnaire
4
Description
Acceptance of internal experiences
Timepoint
Before and after intervention
Method of measurement
AAQ
5
Description
Quality of life
Timepoint
Before and after intervention
Method of measurement
SF-12V2
Secondary outcomes
empty
Intervention groups
1
Description
Applied Relaxation followed the protocol developed by O¨st (1987). An overview of the 12-session program was given, showing patients how they would learn to apply relaxation skills in still shorter times, and that they would learn to apply them in difficult situations. During treatment patients were taught to identify early signs of anxiety and to apply relaxation skills. Starting with progressive relaxation, the therapist taught patients to relax increasingly quickly, to apply relaxation skills during daily activities such as walking, typing, driving a car, etc., and to use these skills to counter anxiety as early as possible.Patients started treatment after a wait of 1 month. Valued Living Questionnaire, Action and Acceptance Questionnaire and Short Form Health Survey -12 revised engagement in Version (SF-12V2) were administered one week before treatment and after the 12th session (posttest) in psychotherapy groups.
Category
Behavior
2
Description
The treatment methods used in this study were ABBT for GAD and AR. Basic ABBT protocol was used that consisted of 16 sessions of individual psychotherapy, but we after getting permission from their authors, used the summarized form about 12 sessions with longer time about 90 min in all sessions. ABBT involves increasing clients’ awareness of patterns of anxious responding, the function of emotions, and the role of experiential avoidance using psychoeducation, experiential demonstrations, and between session monitoring. Clients were also taught a variety of mindfulness practices and were encouraged to establish both formal and informal daily mindfulness practices. Clients also engaged in written exercises about their values. Treatment focused on bringing mindful awareness to valued activities. Patients started treatment after a wait of 1 month. Valued Living Questionnaire, Action and Acceptance Questionnaire and Short Form Health Survey -12 revised engagement in Version (SF-12V2) were administered one week before treatment and after the 12th session (posttest) in psychotherapy groups.
Category
Behavior
3
Description
control group didnt recived any psychotherapy and they only recived medication. Valued Living Questionnaire, Action and Acceptance Questionnaire and Short Form Health Survey -12 revised engagement in Version (SF-12V2) were administered one week before treatment and after the 12th session (posttest) in psychotherapy groups.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatric clinics in Isfahan city
Full name of responsible person
Fatemeh Zargar
Street address
Isfahan, Hossein Abad Ave, 700
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice chancellor for research
Street address
Tehran, 16 Azar, Poursina, 31
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Mental Health Research Center
Full name of responsible person
Fatemeh Zargar
Position
Ph.D in clinical Psychology
Other areas of specialty/work
Street address
Isfahan, Hossein Abad Ave, 700
City
Isfahan
Postal code
Phone
+98 31 1625 8748
Fax
Email
fatemehzargar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mental Health Research Center
Full name of responsible person
Fatemeh Zargar
Position
Ph.D. in clinical psychology
Other areas of specialty/work
Street address
Isfahan, Hossein Abad Ave, 700
City
Isfahan
Postal code
Phone
+98 31 1625 8748
Fax
Email
fatemehzargar@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mental Health Research Center
Full name of responsible person
Fatemeh Zargar
Position
Ph.D. in clinical psychology
Other areas of specialty/work
Street address
Isfahan, Hossein Abad Ave, 700
City
Isfahan
Postal code
Phone
+98 31 1625 8748
Fax
Email
fatemehzargar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)