Compare the Effectiveness of Group Therapy Combination of Acceptance and Commitment Therapy and Habit Reversal Training to Drug Therapy in Reducing Symptoms, Anxiety and Depression of Patients with Trichotillomania
Helping patients with trichotillomania by replacing cognitive therapy rather than drug therapy that has many side effects.
Design
Clinical trial with two intervention groups and a control group in which 30 patients will be assigned by random numbers table.
Settings and conduct
Volunteers participating in the study will be included in the various announcements distributed in the health centers of (Mashhad) and then (30 people) will be selected according to the inclusion criteria. Finally, they will be randomly divided into (three groups of 10 people). The interventions included the first group (receiving 10 sessions and each session for 100 minutes of group therapy combination of habit reversal training and acceptance and commitment treatment), the second group (receiving citalopram with a baseline of 40 mili gram per day, which reached 60 mili gram after 5 weeks and in general, this medication will last for 8 weeks) and the control group (receives only habit reversal training) in the (psychology clinic of the faculty of Educational Sciences of Ferdowsi University of Mashhad).
Participants/Inclusion and exclusion criteria
Inclusion criteria : people with trichotillomania who are between 18 and 50 years old and have at least elementary education.
Exclusion criteria : lack of willingness to cooperate, other mental illnesses and other medical or psychological treatments.
Intervention groups
The first intervention group participates in 10 sessions and each session for 100 minutes of the group therapy combination of habit reversal training and treatment based on acceptance and commitment, the second group will receive citalopram with a baseline of 40 mili gram, which will reach 60 mili gram after 5 week and the the control group receives only 5 sessions and each session is for 40 minutes habit reversal training.
Main outcome variables
Symptoms of trichotillomania, anxiety and depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181009041282N2
Registration date:2018-11-16, 1397/08/25
Registration timing:registered_while_recruiting
Last update:2018-11-16, 1397/08/25
Update count:0
Registration date
2018-11-16, 1397/08/25
Registrant information
Name
Maliheh Eshaghzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5222 6011
Email address
eshaghzadehm2@thums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2018-10-22, 1397/07/30
Actual recruitment end date
2019-01-20, 1397/10/30
Trial completion date
2019-01-20, 1397/10/30
Scientific title
Compare the Effectiveness of Group Therapy Combination of Acceptance and Commitment Therapy and Habit Reversal Training to Drug Therapy in Reducing Symptoms, Anxiety and Depression of Patients with Trichotillomania
Public title
Comparison of the Effectiveness of Habit Reversal Training and Acceptance and Commitment Therapy to Drug Therapy on Patients with Trichotillomania
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical and psychiatric diagnosis of trichotillomania, anxiety and depression
Obtaining a minimum score in the Massachusetts General Hospital (MGH) hair pulling scale, beck depression inventory and beck anxiety inventory.
Age 18 to 50 years old.
Having at least elementary education.
Discontinue psycho-drug treatment at least one month before entering the plan.
Participants do not suffer from psychotic diseases that interfere with this research.
Exclusion criteria:
Unwillingness to cooperate in research
People with other mental and neurological diseases
People who receive different medical or psychological treatments
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:
30
Randomization (investigator's opinion)
Randomized
Randomization description
First of all, 30 subjects who had inclusion criteria were selected and then assigned to two intervention groups and one control group using random block and Randomization.com site.
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 Torbat Heydarieh University of Medical Sciences
Street address
Razi street
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9516915169
Approval date
2016-05-09, 1395/02/20
Ethics committee reference number
IR.THUMS.REC.1395.17
Health conditions studied
1
Description of health condition studied
Trichotillomania
ICD-10 code
F63.3
ICD-10 code description
Trichotillomania
2
Description of health condition studied
Anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
3
Description of health condition studied
Depression
ICD-10 code
F32.9
ICD-10 code description
Major depressive disorder, single episode, unspecified
Primary outcomes
1
Description
Frequency and severity of hair pulling disorder symptoms
Timepoint
At the beginning of the study and after the intervention
Method of measurement
Via The Massachusetts General Hospital (MGH) Hair-Pulling Scale
2
Description
Depression
Timepoint
At the beginning of the study and after the intervention
Method of measurement
Via Beck Depression Inventory
3
Description
Anxiety
Timepoint
At the beginning of the study and after the intervention
Method of measurement
Via Beck Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first intervention group participates in 10 sessions and each session for 100 minutes of group therapy combination of habit reversal training and acceptance and commitment treatment. Acceptance and commitment therapy (ACT) encourages a person to accept what is beyond his control and commitment to social goals. In fact, ACT uses acceptance processes, mindfulness, and change in behavior and commitment to create psychological flexibility.
Category
Treatment - Other
2
Description
Intervention group: The second group receiving citalopram with a baseline of 40 mili gram per day, which reached 60 mili gram after 5 wee and in general, this medication will last for 8 weeks.
Category
Treatment - Drugs
3
Description
Control Group: The control group receives only 5 sessions and each session is for 40 minutes habit reversal training.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychology Clinic and Student Counseling Center of Ferdowsi University of Mashhad
Full name of responsible person
Samaneh Eshaghzadeh
Street address
Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 5000
Email
pr@um.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Ahmad Reza Bahrami
Street address
Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 2512
Email
ar-bahrami@um.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ferdowsi University of Mashhad
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
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Samaneh Eshaghzadeh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Razi street
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9516915169
Phone
+98 51 5222 6011
Email
s.eshaghzadeh0@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Samaneh Eshaghzadeh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Razi street
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9516915169
Phone
+98 51 5222 6011
Email
s.eshaghzadeh0@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Maliheh Eshaghzadeh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Razi street
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9516915169
Phone
+98 51 5222 6011
Email
m.eshaghzadeh93@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
Undecided - It is not yet known if there will be 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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available