Protocol summary

Summary
The aim of the present study is to compare the efficacy of short message text (interactive and non-interactive) on treatment adherence, severity of depression and spiritual health in patients with major depression. Study is an quasi experimental, non-blinded, single center, with control group. The study population is eligible depressed patients referred to Hajar Hospital’s Psychiatry Clinic in Shahrekord. Inclusion criteria are major depression according to diagnosis of a psychiatrist and DSM-IV-TR criteria, being literate, ability to work with cell phone and reading and writing text message and exclusion criteria are refusing to participate in the study and lack of cooperation during the intervention. The study sample consists of 90 eligible depressed patients. These patients will be allocated to three groups (30 in each groups): interactive short message, non-interactive short message, and without short message. In non-interactive message group, the patients would receive every day hopeful messages derived from traditions and elite, and tips about side effects, percussion, and medication reminder for 6 weeks. In the interactive message group, the same messages would be sent in an interactive form in a similar way. Spiritual well- being, depression severity, and treatment adherence of the patients would be assessed by Paloutzian and Ellison spiritual well-being scale, Beck Depression Inventory, and treatment adherence researcher-made questionnaire at beginning and the end of intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015091323998N1
Registration date: 2015-10-25, 1394/08/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-10-25, 1394/08/03
Registrant information
Name
Aeen Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4203 6001
Email address
aeen_mohammadi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-10-22, 1394/07/30
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial for comparison the effects of sending one-way short message, interactive short message and not sending any message on adherence to medication, depression, and spiritual health among patients with major depression
Public title
Efficacy of short message services on treatment adherence, severity of depression and spiritual health in depressed patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: major depression according to diagnosis of a psychiatrist and DSM-IV-TR criteria; being literate; being able to work with cell phone and reading and writing a text message Exclusion criteria: refusing to participate in the study and lack of cooperation during the intervention
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Participants are going to be non randomly allocated to three groups.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Keshvarz Blvd.,Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2015-07-11, 1394/04/20
Ethics committee reference number
IR.TUMS.REC.1394.357

Health conditions studied

1

Description of health condition studied
Depressive episode
ICD-10 code
F32.1
ICD-10 code description
Moderate depressive episode

2

Description of health condition studied
Depressive episode
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode

Primary outcomes

1

Description
Spiritual well- being
Timepoint
The beginning and end of the study
Method of measurement
Paloutzian and Ellison spiritual well-being scale

2

Description
Depression severity
Timepoint
The beginning and end of the study
Method of measurement
Beck Depression Inventory (21 question)

3

Description
Treatment adherence
Timepoint
The beginning and end of the study
Method of measurement
Treatment adherence self- made questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: The patients in control group will not be received any short messages.
Category
N/A

2

Description
Non- interactive message group: In this group the patients receive every day hopeful message derived from traditions and elite, and tips about side effects, percussion, and medication reminder for 6 weeks.
Category
Other

3

Description
Interactive message group: In this group the patients receive every day hopeful message derived traditions and elite, and tips about side effects, percussion, and medication reminder, to which should be answered by the patient using short message for 6 weeks.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar Hospital’s Psychiatry Clinic in Shahrekord
Full name of responsible person
Ms Najmeh Shahinfard
Street address
Hajar Hospital’s psychiatry clinic in Shahrekord
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
ِDr. Masud Yunesian
Street address
Keshavarz Blvd., Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
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
Virtual School, Tehran University of Medical Sciences
Full name of responsible person
Najme Shahinfard
Position
MSc student of E-learning in Medical Education
Other areas of specialty/work
Street address
Dolatshahi Alley, Naderi St., Keshavarz Blvd., Virtual School, Tehran University of Medical Sciences
City
Tehran
Postal code
1417653761
Phone
+98 21 8897 8088
Fax
Email
shahinfardn@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Aeen Mohammadi
Position
MD, MPH, Ph.D of Medical Education
Other areas of specialty/work
Street address
Dolatshahi Alley, Naderi St., Keshavarz Blvd., Virtual School, Tehran University of Medical Sciences
City
Tehran
Postal code
1417653761
Phone
+98 21 8897 8088
Fax
Email
aeen_mohammadi@tums.ac.ir
Web page address
http://tums.ac.ir/faculties/aeen_mohammadi

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Aeen Mohammadi
Position
Ph.D of Medical Education
Other areas of specialty/work
Street address
Dolatshahi Alley, Naderi St., Keshavarz Blvd., Virtual School, Tehran University of Medical Sciences
City
Tehran
Postal code
1417653761
Phone
+98 21 8897 8088
Fax
Email
aeen_mohammadi@tums.ac.ir
Web page address
http://tums.ac.ir/faculties/aeen_mohammadi

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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