Comparison of the efficacy of Cognitive-Behavioral Therapy for Perfectionism (CBT-P) versus Unified Protocol for Transdiagnostic Treatment (UP) in the individuals with clinical perfectionism and anxiety and depressive disorders
The purpose of this study is comparison of efficacy of Cognitive-Behavioral Therapy for Perfectionism (CBT-P), Unified Protocol for Transdiagnostic Treatment (UP), and waitlist control group in reduction in symptoms of depression and anxiety and transdiagnostic factors in the individuals with anxiety and depressive disorders and with clinical perfectionism too.
Design
First, by using sample size determination formula and with predicting the drop out of participants during the research process, 90 eligible individuals are randomly allocated to two treatment and one control conditions
Settings and conduct
The study is conducted in the psychology ward of Taleghani Hospital of Tehran and Shahid Beheshti University Counseling Center. Both treatments are administered individually and by one therapist (due to the similarity of both therapeutic approaches and the control of the therapist effect).
Participants/Inclusion and exclusion criteria
Age over 18 years; Diagnosis of at least one of anxiety disorders or depression; High perfectionism; No severe or moderate suicidality; Absence of psychosis; No substance or drug abuse; No drug treatment or other psychotherapies simultaneously.
Intervention groups
A group treated with cognitive-behavioral perfectionism; a group treated with the UP model of transdiagnostic treatment; the waiting list group did not receive intervention until the end of the treatment sessions.
Main outcome variables
Level of Perfectionism; General Severity of Anxiety; General Severity of Depression; Severity of Social Anxiety; Severity of panic; strategies of Emotion Regulation; Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190713044191N1
Registration date:2019-09-15, 1398/06/24
Registration timing:retrospective
Last update:2019-09-15, 1398/06/24
Update count:0
Registration date
2019-09-15, 1398/06/24
Registrant information
Name
Mohammad Mahmoodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3727 3568
Email address
mahmoodi_m13@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-22, 1396/02/02
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
2017-04-22, 1396/02/02
Actual recruitment end date
2017-07-23, 1396/05/01
Trial completion date
2018-11-03, 1397/08/12
Scientific title
Comparison of the efficacy of Cognitive-Behavioral Therapy for Perfectionism (CBT-P) versus Unified Protocol for Transdiagnostic Treatment (UP) in the individuals with clinical perfectionism and anxiety and depressive disorders
Public title
Comparison of the efficacy of Cognitive-Behavioral Therapy for Perfectionism (CBT-P) versus Unified Protocol for Transdiagnostic Treatment (UP) in the individuals with emotional disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
To have elevated perfectionism, defined by a score greater than 24.7 on the Concern over Mistakes (CM) subscale of the Frost Multidimensional Perfectionism Scale
A score greater than18 on the depression (D) and greater than16 on the anxiety (A), subscales of the DAS Scale
Diagnosis of one of anxiety disorders or depression at least, based on diagnostic criterias in DSM-5
Exclusion criteria:
self-harm behaviors
moderate or severe suicidality
psychosis
drug or substance abuse
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
64
Randomization (investigator's opinion)
Randomized
Randomization description
After baseline assessment, participants are randomly allocated
to treatment or control conditions. Randomisation is conducted
using randomised number lists generated by Saghaei's (2004)
Random Allocation Software Version 1.0
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 Shahid Beheshti University of Medical Sciences
Street address
Third Floor, Faculty of Medicine, next toTaleghani Hospital, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
193954719
Approval date
2017-01-31, 1395/11/12
Ethics committee reference number
IR.SBMU.MSP.REC.1395.439
Health conditions studied
1
Description of health condition studied
Major depressive disorder, single episode
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
2
Description of health condition studied
Major depressive disorder, recurrent
ICD-10 code
F33
ICD-10 code description
Major depressive disorder, recurrent
3
Description of health condition studied
Persistent mood disorders
ICD-10 code
F34
ICD-10 code description
Persistent mood [affective] disorders
4
Description of health condition studied
Social phobia
ICD-10 code
F40.1
ICD-10 code description
Social phobias
5
Description of health condition studied
Panic disorder
ICD-10 code
F41.0
ICD-10 code description
Panic disorder
6
Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
7
Description of health condition studied
Mixed anxiety and depressive disorder
ICD-10 code
F41.2
ICD-10 code description
Mixed anxiety and depressive disorder
8
Description of health condition studied
Other mixed anxiety disorders
ICD-10 code
F41.3
ICD-10 code description
Other mixed anxiety disorders
Primary outcomes
1
Description
The general severity of anxiety
Timepoint
At baseline, at the end of treatment, and 3 months after treatment
Method of measurement
Beck Anxiety Inventory
2
Description
The general severity of depression
Timepoint
At baseline, at the end of treatment, and 3 months after treatment
Method of measurement
Beck Depression Inventory
3
Description
The severity of social anxiety
Timepoint
At baseline, at the end of treatment, and 3 months after treatment
Method of measurement
Connor Social Phobia Inventory (SPIN)
4
Description
The severity of Panic
Timepoint
At baseline, at the end of treatment, and 3 months after treatment
Method of measurement
Anxiety Sensitivity Inventory (ASI)
5
Description
The level of perfectionism
Timepoint
At baseline, at the end of treatment, and 3 months after treatment
Method of measurement
The Frost Multidimensional Perfectionism Scale (FMPS)
6
Description
Emotion regulation strategies
Timepoint
At baseline, at the end of treatment, and 3 months after treatment
Method of measurement
Growth Emotion Regulation Questionnaire (ERQ)
7
Description
Quality of Life
Timepoint
At baseline, at the end of treatment, and 3 months after treatment
Method of measurement
WHO Quality of Life Questionnaire (WHOQOL)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Cognitive Behavioral Treatment of Perfectionism (CBT-P): It consists of 12 therapeutic sessions that have been developed step by step based on the protocol proposed by Egan et al, (2014). sessions are held individually and once a week and each session lasts one hour.
Category
Treatment - Other
2
Description
Intervention group 2: Unified Transdiagnostic Treatment (UP): It consists of 12 therapeutic sessions that have been developed step by step based on the protocol proposed by Barlow et al, (2011). sessions are held individually and once a week and each session lasts one hour.