Comparison of the Effectiveness of Compassion Focused Therapy (CFT) and Acceptance and Commitment Therapy (ACT) in Patients with Generalized Social Anxiety Disorder
The purpose of this study is comparison the effectiveness of Compassion Focused Therapy (CFT) and Acceptance and Commitment Therapy (ACT) in patients with Generalized Social Anxiety Disorder (SAD). The present research is randomized controlled trial study with pre-test, post-test and follow-up along with a control group. 48 patients with SAD was randomly allocated to one of the 3 groups: CFT, ACT and control group. 12 weekly sessions individual intervention based on CFT for one group and 12 weekly sessions individual intervention based on ACT for another group will run. the control group did not receive any treatment. At the beginning of the research, after 12 weeks and after a follow-up period of 8 weeks, research variables will be evaluated.
After the necessary coordination with Tehran Psychiatric Institute's authorities and considering the individuality of the treatments, each member of the sample was randomly assigned to a group through flipping a coin.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Suffering social anxiety disorder; Age range 20-40; Consent to participate in the research; The minimum Diploma education.
Exclusion Criteria: Suffering other psychiatric disorders; Suffering severe levels of personality disorders; Severe physical illnesses; The initiation of treatment with psychiatric drugs within the last 3 months or change of drug dose during that time.
Intervention groups
The CFT group received 12 individual treatment sessions based on the Boersma et al protocol (2014).
The ACT group received 12 individual treatment sessions based on the Eifert and Forsyth protocol (2005).
The control group did not receive any treatment.
Main outcome variables
social anxiety symptoms; self-criticism; psychological flexibility; quality of life; mindfulness; self-compassion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180607040000N1
Registration date:2018-06-18, 1397/03/28
Registration timing:retrospective
Last update:2018-06-18, 1397/03/28
Update count:0
Registration date
2018-06-18, 1397/03/28
Registrant information
Name
Komeil Zahedi Tajrishi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1657
Email address
zahedi.komeil@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-11, 1396/09/20
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
2017-12-11, 1396/09/20
Actual recruitment end date
2018-01-10, 1396/10/20
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Compassion Focused Therapy (CFT) and Acceptance and Commitment Therapy (ACT) in Patients with Generalized Social Anxiety Disorder
Public title
Effect of Compassion Focused Therapy (CFT) and Acceptance and Commitment Therapy (ACT) on Social Anxiety Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering social anxiety disorder based on DSM5 diagnostic criteria (in case of other psychiatric diagnoses, SAD diagnosis should have been clearly identified as the primary diagnosis)
Age between 20-40 years
Consent to participate in the research and completing the treatment sessions
The minimum Diploma education
Exclusion criteria:
Suffering other psychiatric disorders of the first axis that are an obstacle to the treatment of Social Anxiety Disorder (e.g. Psychotic disorders, Bipolar disorder with psychotic features )
Suffering severe levels of personality disorders with serious communication problems including Schizotypal, Schizoid, Paranoid, Borderline, Antisocial, and Avoidant personality disorders
Suffering severe physical illnesses such as Cancer and AIDS, whose physical illness should be prioritized for treatment
The initiation of treatment with psychiatric drugs within the last 3 months or change of drug dose during that time.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Considering the individuality of the treatments, each member of the sample assigned to a group with simple randomization and through flipping a coin.
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
Ethics committee of Iran University of Medical Sciences
Street address
Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1333813444
Approval date
2017-12-08, 1396/09/17
Ethics committee reference number
IR.IUMS.REC 1396.9211521214
Health conditions studied
1
Description of health condition studied
Social Anxiety Disorder
ICD-10 code
F40.11
ICD-10 code description
Social phobia, generalized
Primary outcomes
1
Description
Social Anxiety Symptom
Timepoint
Before intervention, After intervention, After a follow-up period of 8 weeks
Method of measurement
Liebowitz Social Anxiety Scale (LSAS)
2
Description
Quality of Life
Timepoint
Before intervention, After intervention, After a follow-up period of 8 weeks
Method of measurement
World Health Organization Questionnaire of the Quality of Life (WHOQOL-BREF)
3
Description
Psychological Flexibility
Timepoint
Before intervention, After intervention, After a follow-up period of 8 weeks
Method of measurement
Acceptance and Action Questionnaire-second version (AAQ-II)
4
Description
Self Compassion
Timepoint
Before intervention, After intervention, After a follow-up period of 8 weeks
Method of measurement
Self-Compassion Scale (SCS)
5
Description
Self-Criticism
Timepoint
Before intervention, After intervention, After a follow-up period of 8 weeks
Method of measurement
Level of Self-Criticism Scale (LOSC)
6
Description
Mindfulness
Timepoint
Before intervention, After intervention, After a follow-up period of 8 weeks
Method of measurement
Ryan and Brown's Mindful Attention Awareness Scale (MAAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (1st): Compassion Focused Therapy (CFT) group that received 12 individual treatment sessions of one hour based on the protocol used in the study of Boersma et al. (2014).
Category
Behavior
2
Description
Intervention group (2nd): Acceptance and Commitment Therapy (ACT) group that received 12 individual treatment sessions of one hour based on the Eifert and Forsyth protocol (2005).
Category
Behavior
3
Description
Control group: did not receive any treatment interventions and were merely put on the waiting list.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Behavioral Sciences and Mental Health Clinic
Full name of responsible person
Komeil Zahedi Tajrishi
Street address
School of Behavioral Sciences and Mental Health, Mansou of Behavioral Sciences and Mental Health, Mansouri St, Niyayesh St, Sattarkhan St, Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1515
Email
zahedi.komeil@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Banafsheh Gharraee
Street address
School of Behavioral Sciences and Mental Health, Mansouri St, Niyayesh St, Sattarkhan St, Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1657
Email
gharraee.b@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Komeil Zahedi Tajrishi
Position
Ph.D student in clinical psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Behavioral Sciences and Mental Health, Mansouri St, Niyayesh St, Sattarkhan St, Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1657
Email
zahedi.komeil@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Komeil Zahedi Tajrishi
Position
Ph.D student of clinical psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Behavioral Sciences and Mental Health, Mansouri St, Niyayesh St, Sattarkhan St, Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1657
Email
zahedi.komeil@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Komeil Zahedi Tajrishi
Position
Ph.D student of clinical psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Behavioral Sciences and Mental Health, Mansouri St, Niyayesh St, Sattarkhan St, Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1657
Email
zahedi.komeil@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available