The effect of short-term behavioral activation intervention on the symptoms of patients with depression-mixed anxiety
Design
The clinical trial will have a control group, one-way blind, randomized, on 30 patients, assigned to the intervention or control group by Randomization in the two groups.
Settings and conduct
With a daily lottery between two couples and an individual lottery in Alborz psychiatric clinics, if any of the individual or couple samples are selected on that day to be included in the study. And then 8 sessions of individual behavior therapy counseling are held over the phone for at least one hour and twice a week.
Participants/Inclusion and exclusion criteria
Entry requirements: 1) Having Depression with Anxiety Based on the First Screening with the Hamilton Depression and Anxiety Questionnaire. 2) No symptoms or psychotic disorder 3) Ability to communicate by telephone and understand Persian language.
No entry conditions: 1) Non-cooperation during the study 2) Non-participation in more than two non-pup sessions or in two consecutive sessions
Intervention groups
Each patient in the intervention group will receive 8 sessions of individual behavioral therapy counseling over the phone, lasting at least one hour and twice a week. The control group will receive routine care.
Main outcome variables
Achieving the effect of short-term behavioral activation on the symptoms of patients with depression - mixed anxiety.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151003024312N6
Registration date:2021-09-13, 1400/06/22
Registration timing:registered_while_recruiting
Last update:2021-09-13, 1400/06/22
Update count:0
Registration date
2021-09-13, 1400/06/22
Registrant information
Name
Fataneh Ghadirian Baharanchi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4311
Email address
ghadirian.fataneh@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effects of Brief Behavioral Activation (BA) Therapy on Symptoms of Patients with Mixed Depression and Anxiety
Public title
Investigating the Effects of Brief Behavioral Activation (BA) Therapy on Symptoms of Patients with Mixed Depression and Anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having both depressive and anxiety disorders according the primary screening by Hamilton anxiety and depression questionnaires
Exclusion criteria:
Not having psychiatric symptoms or disorder (According to the medical history and socidemographic questionnaire)
Not having Post Traumatic Stress Syndome aor Disorder and substance abuse (According to the medical history and socidemographic questionnaire)
Not having severe stressful and disabaling physical problems
Not happening stressful events during the 6 months ago
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The only statistical analyzer of the codes assigned to the groups will be uninformed to eliminate bias in the analysis.
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
Shahid Beheshti University of Medical Sciences_ Next to Taleghani Hospital _Yaman Street - Shahid Chamran Highway_ Tehran.
City
Tehran
Province
Alborz
Postal code
1985717443
Approval date
2021-06-29, 1400/04/08
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.077
Health conditions studied
1
Description of health condition studied
Mixed Depression and Anxiety
ICD-10 code
F43.23
ICD-10 code description
Adjustment disorder with mixed anxiety and depressed mood
Primary outcomes
1
Description
Depression score at Hamilton questionnaire
Timepoint
Before, Immediately after and one month after the intervention
Method of measurement
Hamilton Depression Inventory
2
Description
Anxiety score at Hmilton questionnaire
Timepoint
Before, Immediately after and one month after the intervention
Method of measurement
Hamilton Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group:" Interventions will be done individually. Each patient will receive 8 sessions of individual behavior therapy counseling over the phone, lasting at least one hour and twice a week.
Category
Rehabilitation
2
Description
"Control group: "This group receives routine care as directed by the clinic physician.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatric Clinic of Imam Hossein Hospital, Karaj
Full name of responsible person
Fataneh Ghadirian
Street address
School of Nursing and Midwifery_ Intersection of Niyayesh St_ Valie-asr St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 26 3419 3172
Email
ghadirian@sbmu.ac.ir
Web page address
https://isid.research.ac.ir/Fataneh_Ghadirian
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fataneh ghadirian
Street address
School of Nursing and Midwifery_ Intersection of Niyayesh St_ Valie-asr St
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5369
Email
ghadirian@sbmu.ac.ir
Web page address
https://isid.research.ac.ir/Fataneh_Ghadirian
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fataneh Ghadirian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery_ Intersection of Niyayesh St_ Valie-asr St
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5363
Email
ghadirian@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fataneh ghadirian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery_ Intersection of Niyayesh St_ Valie-asr St
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5363
Fax
Email
ghadirian@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahsa sadat hayati deruyi
Position
Master of Psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kahrizak Charity Sanatorium of Alborz Province: End of Golestanak St. - Beginning of Saheb Al-Zaman St_ Mohammadshahr .
City
Tehran
Province
Alborz
Postal code
3185946781
Phone
+98 26 3630 9171
Email
mahiideruyi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After removing the ID codes, all of the data can be shared.
When the data will become available and for how long
Access date begins from the 6 months after the last published paper.
To whom data/document is available
Scientific researchers and university scholars and also researchers in industry.
Under which criteria data/document could be used
Only for scientific researches development and also planning for evidence-based care.
From where data/document is obtainable
Fataneh Ghadirian
E-mail: ghadirian@sbmu.a.c.ir
What processes are involved for a request to access data/document
It needs the approval of ethics committee of the Nursing and Midwifery School.