The effectiveness of Mindfulness-Based Stress Reduction on decreasing depression and Anxiety levels, and improving Quality of Life of the women with generalized anxiety disorder
This study has been conducted to investigate the effectiveness of Mindfulness-Based Stress Reduction on Quality of Life, stress, anxiety in Patients with generalized anxiety disorder. This research was conducted by using semi- experimental study with pretest-posttest design, using control group. So, from females with generalized anxiety disorder who appointed in Imam Hossein hospital in Tehran in 2013, 34 participants were selected and randomly assigned in two equal experimental and control groups. Experimental group experienced 8 weeks over120 minutes of Mindfulness-Based Stress Reduction therapy. data will gather by BDI, BAI, PWI-A, GAD-7 at pre interventoin phase and from treatment initiation to eight week after that. both groups will compare on Quality of Life, stress, anxiety at the end of eight week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014110819855N1
Registration date:2014-12-30, 1393/10/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-30, 1393/10/09
Registrant information
Name
Samira Masumian
Name of organization / entity
Tehran Psychiatry Institue
Country
Iran (Islamic Republic of)
Phone
+98 21 3349 6990
Email address
samira.masumian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2014-11-26, 1393/09/05
Expected recruitment end date
2015-03-22, 1394/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Mindfulness-Based Stress Reduction on decreasing depression and Anxiety levels, and improving Quality of Life of the women with generalized anxiety disorder
Public title
Effectiveness of Mindfulness-Based Stress Reduction therapy on patient with generalized anxiety disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Informed consent; age range of 18 - 40 years; being female Exclusion criteria: Underlying medical diseases and psychological disorders(Psychosis, demantia, cancer); receiving any other treatment (including psychotherapy)
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Hemat Highway, Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Approval date
2014-08-25, 1393/06/03
Ethics committee reference number
24477
Health conditions studied
1
Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstances (i.e. it is "free-floating"). The dominant symptoms are variable but include complaints of persistent nervousne
Primary outcomes
1
Description
Depression
Timepoint
pretest.posttest (at the end of 8 session)
Method of measurement
Beck inventory
2
Description
Anxiety
Timepoint
pretest.posttest (at the end of 8 session)
Method of measurement
Beck anxiety
3
Description
Generalized anxiety
Timepoint
pretest.posttest (at the end of 8 session)
Method of measurement
Generalized anxiety inventory
4
Description
Quality of life
Timepoint
pretest.posttest (at the end of 8 session)
Method of measurement
Quality of life inventory
Secondary outcomes
empty
Intervention groups
1
Description
WEEKS 1 and 2) Raisin exercise Body scans meditation, 6 days per week, 45 minutes a day. Sitting with awareness of breathing, 10 minutes per day. Mindfulness of breathing meditation. WEEKS 3 and 4) Alternate body scan with yoga (45 minutes) if possible, 6 days per week. Continue sitting with awareness of breathing, 15-20 minutes per day. Focusingon one unpleasant event each day and completing an unpleasant – events diary. Three-step breathing space. WEEKS 5 and 6) Full sitting meditation practice. Sit 30-45 minutes per day, alternating with yoga. Begin. walking meditation. Three-step breathing space, Three times a day and as needed. WEEK 7) Longer sitting meditation Practice 45 minutes per day using your own choice of methods, either alone or in combination. WEEK 8) Go back to using tapes. Do body scan at least twice this week. Reviewing the course as a whole. Continue the sitting and the yoga.
Category
Other
2
Description
They had no treatment and were in waiting list
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hosein Haspital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mental Health Research Center
Full name of responsible person
Seyed Vahid Shariat
Street address
Iran University of Medical Sciences, Hemat Highway, Tehran, Iran
City
Iran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mental Health Research Center
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
Tehran Psychiatry Institue
Full name of responsible person
Samira Masumian
Position
Student Of Phd
Other areas of specialty/work
Street address
Satarkhan, Tehran Psychiatry Institue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 3349 6990
Fax
Email
samira.masumian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Psychiatry Institue
Full name of responsible person
Samira Masumian
Position
Student Of Phd
Other areas of specialty/work
Street address
Satarkhan, Tehran Psychiatry Institue
City
Tehran
Postal code
Phone
+98 21 3349 6990
Fax
Email
samira.masumian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Psychiatry Institue
Full name of responsible person
Samira Masumian
Position
Student Of Phd
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)