Protocol summary

Summary
Objective: This study sought to assess the effect of “group cognitive therapy” for raising hope among tuberculosis patients hospitalized in Masih Daneshvari Hospital. Method: The inclusion criteria: diagnosis of tuberculosis, male gender, minimum age of 18 yrs., complete consciousness, no substance abuse and no history of psychiatric drug consumption. The study population included all male tuberculosis patients hospitalized in Masih Daneshvari Hospital during May 2012-May 2013. Sampling method: All patients with tuberculosis (24 patients) who had inclusion criteria were selected and then they were divided to experimental and control groups by simple randomized method. This applicable study had a pre-test and post-test design and the test and control groups were compared. Hope was measured in the test group before and after the intervention (cognitive therapy in 12 sessions of 60 min each) and in the control group (twice, no intervention) using Snyder’s Hope Scale. Results: Group cognitive therapy in the experimental group significantly raised hope (motivation and determination to find a solution) in comparison to the control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013111515405N1
Registration date: 2014-01-13, 1392/10/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-01-13, 1392/10/23
Registrant information
Name
Mitra Safa
Name of organization / entity
Massih Daneshvari Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2607
Email address
m.safa@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Massih Daneshvari Hospital
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of group cognitive therapy for raising hope in two groups of male tuberculosis patients
Public title
Effect of group cognitive therapy for raising hope in two groups of male tuberculosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: minimum age of 18 yrs.; male gender; definite diagnosis of tuberculosis; no substance abuse and no history of psychiatric drug consumption; presenting informed consent; complete consciousness Exclusion criteria: being under 18 yrs; female gender; no definite diagnosis of tuberculosis; substance abuse and history of psychiatric drug consumption; willing to quit the project; no consciousness
Age
From 18 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
N/A
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
Massih Daneshvari Hospital
Street address
Massih Daneshvari Hospital- Darabad Street- Niavaran- Tehran
City
Tehran
Postal code
19569-44413
Approval date
2011-12-22, 1390/10/01
Ethics committee reference number
C-90-860

Health conditions studied

1

Description of health condition studied
tuberculosis disease
ICD-10 code
A15
ICD-10 code description
A15-A16 infection of mycobacterium tuberculosis

Primary outcomes

1

Description
Hopefulness level changes
Timepoint
1 month
Method of measurement
Snyder Hopefulness Scale

Secondary outcomes

empty

Intervention groups

1

Description
Group cognitive therapy
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Massih Daneshvari Hospital
Full name of responsible person
Mitra Safa
Street address
Masih Daneshvari Hospital, Darabad Street, Niavaran, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Massih Daneshvari Hospital
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
Masih Daneshvari Hospital
Full name of responsible person
Mitra Safa
Position
psychiatry/ psychiarist
Other areas of specialty/work
Street address
Masih Daneshvari Hospital- Darabad Street-Niavaran-Tehran
City
Tehran
Postal code
Phone
+98 21 2712 2607
Fax
Email
anahita86@yahoo.com; m.safa@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Massih daneshvari Hospital
Full name of responsible person
Mitra Safa
Position
psychiatry
Other areas of specialty/work
Street address
Massih Daneshvari Hospital- Darabad- Niavaran- Tehran
City
Tehran
Postal code
Phone
+98 21 2712 2607
Fax
Email
anahita86@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Massih Daneshvari Hospital
Full name of responsible person
Mitra Safa
Position
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 27122607
Fax
Email
anahita86@yahoo.com;m.safa@sbmu.ac.ir
Web page address

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
empty
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