Comparing the effect of mindfulness-based cognitive behavioral therapy and hypiran on depression and quality of life of patients with major depressive disorder
The aim of this study is to comparing the effect of mindfulness-based cognitive behavioral therapy (MBCT) and hypiran on depression and quality of life of patients with major depressive disorder.
Design
Clinical trials with control group, community based
and pragmatic with parallel groups, non-randomized
Settings and conduct
In this study, 55 patients suffering from moderate or severe underlying depression will enroll into the study, based on psychiatrist's diagnosis using the convenience sampling method, from the psychiatric department of Hajar Hospital and Hazrat Rasoul Clinic in Shahrekord.
Participants/Inclusion and exclusion criteria
Inclusion criteria: suffering from moderate or severe underlying depression, based on psychiatrist's diagnosis, education level of at least elementary school and age over 10 years old; and patients having organic brain disorders and mental retardation and having other underlying psychiatric disorders will not enrolled in the study.
Intervention groups
Patients will divide into four groups. All groups will receive fluoxetine, as a standard treatment, at a dose of 20-60 mg. In addition, Group 1, will receive 8 sessions of MBCT and second group, 60 drops of herbal Hypiran drop per day for 2 months based on the brochure will receive. Each ml of Hypiran drop (Poursina, Iran) contains 0.25 mg of hypericin (hydroalcoholic extract of the tea plant).
The third group, in addition to standard medication will receive 8 sessions of MBCT treatment and 60 drops of Hypiran per day for 2 months and fourth group (control group) will underwent the standard medication alone.
Main outcome variables
Changes in the symptoms of depression; Changes in quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110514006480N17
Registration date:2018-10-13, 1397/07/21
Registration timing:registered_while_recruiting
Last update:2018-10-13, 1397/07/21
Update count:0
Registration date
2018-10-13, 1397/07/21
Registrant information
Name
Mohammad Taghi Moradi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 9509
Email address
mtmoradi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of mindfulness-based cognitive behavioral therapy and hypiran on depression and quality of life of patients with major depressive disorder
Public title
Effect of mindfulness-based cognitive behavioral therapy on patients with major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate or severe underlying depression, based on psychiatrist's diagnosis
Education level of at least elementary school
Age over 10 years old
Exclusion criteria:
Having organic brain disorders and mental retardation
Having other underlying psychiatric disorders
Age
From 10 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
55
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Shahrekord University of Medical Sciences
Street address
Vice Chancellor for research, Shahrekord University of Medical Sciences, Kashani Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2017-04-24, 1396/02/04
Ethics committee reference number
IR.SKUMS.REC.1396.38
Health conditions studied
1
Description of health condition studied
Major depressive disorder (moderate )
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate
2
Description of health condition studied
Major depressive disorder (severe)
ICD-10 code
F32.2
ICD-10 code description
Major depressive disorder, single episode, severe without psychotic features
Primary outcomes
1
Description
Depression status
Timepoint
Before the intervention, two months after starting treatment
Method of measurement
The Beck questionnaire
2
Description
Quality of life status
Timepoint
Before the intervention, two months after starting treatment
Method of measurement
SF-36 quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: They will receive oral fluoxetine, as a standard treatment, at a dose of 20-60 mg, for 2 months.
Category
Treatment - Drugs
2
Description
Intervention group 1: They will receive 8 sessions of mindfulness-based cognitive behavioral therapy (MBCT) in addition to oral fluoxetine (20-60 mg, for 2 months).The overall structure of the MBCT program was 2- to 2.5-hour sessions over an eight week period. A structured program of homework including 45 minutes of daily practice, formal exercises, and in some days unofficial mind-boggling exercises was also used, and sometimes the individual recorded his/her observations of his/her own daily experiences.
Category
Treatment - Other
3
Description
Intervention group 2: In addition to fluoxetine (20-60 mg, for 2 months), they will receive 60 drops of herbal Hypiran drop per day for 2 months based on the brochure. Each ml of Hypiran drop (Poursina, Iran) contains 0.25 mg of hypericin (hydroalcoholic extract of the tea plant).
Category
Treatment - Drugs
4
Description
Intervention group 3: In addition to fluoxetine (20-60 mg, for 2 months), they will receive 8 sessions of MBCT treatment and 60 drops of Hypiran per day for 2 months. The overall structure of the MBCT program was 2- to 2.5-hour sessions over an eight week period. A structured program of homework including 45 minutes of daily practice, formal exercises, and in some days unofficial mind-boggling exercises was also used, and sometimes the individual recorded his/her observations of his/her own daily experiences.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Doctor Seyed-Kamal Solati
Street address
Psychiatry Department, Hajar Hospital, Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۸۵۴۶۳۳
Phone
+98 38 3222 5505
Fax
+98 38 3224 3715
Email
kamal_solati@yahoo.com
2
Recruitment center
Name of recruitment center
Shahrekord specialized clinic of Hazrate Rasoul (SA)
Full name of responsible person
Seyed Kamal Solati
Street address
Specialized clinic of Hazrate Rasoul (SA), Molavi four-way, Shahrekord