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The Effectiveness of Group Therapy Based on Acceptance and Commitment on Cognitive Flexibility, Suicide Ideation, Depression and Hopelessness in Soldiers

Protocol summary

Study aim
The Aim of Study Will be to Investigate the Effectiveness of Group Therapy Based on Acceptance and Commitment on Cognitive Flexibility, Suicide Ideation, Depression and Hopelessness in Soldiers
Design
In an Experimental Study With a Pretest -Posttest Control Group Design, 30 Depressed Soldiers Will be Selected Through Convenience Sampling Method.
Settings and conduct
The Province Mashhad Will be Assign to Two Experimental and Control Groups, Each Contain 15 Individuals.
Participants/Inclusion and exclusion criteria
The inclusion criteria: Aged between 18 to 40 years, having at least a high school diploma, Willingness to participate in the study and being randomly into one of the study groups, Earning a score of 17 or above on the Beck Depression Inventory - Second Edition,,Completing the agreement form. The exclusion criteria: Having physical and mental diseases, Receiving intrudent pharmacological and non pharmacological treatments, Patients with any serious psychological disorders (including psychotic disorders or active substance abuse),Education less than fifth elementary
Intervention groups
Experimental Group: The Intervention group will attend Acceptance and Commitment Group Therapy Sessions for 8 Weeks (8 sessions of two hour). In General, the Treatment Plan for this Group Will be to at Assess Previous Session Homework, Teaching a New Technique and Giving Homework for Future Session. Control group:The control group simultaneously (8 two-hour sessions for 8 weeks) will continue usual care plan of the group.
Main outcome variables
Increase Cognitive Flexibility, Decrease Ideating Thoughts, Hopelessness and Depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180218038786N2
Registration date: 2019-08-30, 1398/06/08
Registration timing: retrospective

Last update: 2019-08-30, 1398/06/08
Update count: 0
Registration date
2019-08-30, 1398/06/08
Registrant information
Name
Zahra Robati
Name of organization / entity
Semnan University
Country
Iran (Islamic Republic of)
Phone
+98 23 3362 4250
Email address
robati.zahra@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-08, 1398/04/17
Expected recruitment end date
2019-08-01, 1398/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Group Therapy Based on Acceptance and Commitment on Cognitive Flexibility, Suicide Ideation, Depression and Hopelessness in Soldiers
Public title
The effect of Group Therapy Based on Acceptance and Commitment on Cognitive Flexibility, Suicide Ideation, Depression and Hopelessness in Soldiers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 18 to 40 years Having at least a high school diploma Willingness to participate in the study being randomly into one of the study groups Completing the agreement form Earning a score of 17 or above on the Beck Depression Inventory - Second Edition
Exclusion criteria:
Having with any serious psychological disorders (including psychotic disorders or active substance abuse) Receiving intrudent pharmacological and non pharmacological treatments Education less than fifth elementary
Age
From 18 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation method will be simple random. Hiding the assignment using a computer is that the computer creates random numbers between zero and one. If the random number is less than 0/005, the individual will be assigned to the test group, and if the random number is greater than 0/005, the individual will be entered into the control group. In this process, people who enter the study list will not be aware of how the treatment is allocated before the intervention.
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
Vice chancellor for research, Hakim Sabzevari University
Street address
Tohid Shahr, Hakim Sabzevari University
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Approval date
2019-07-24, 1398/05/02
Ethics committee reference number
IR.HSU.REC.1398.016

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F06.31
ICD-10 code description
Mood disorder due to known physiological condition with depressive features

Primary outcomes

1

Description
Cognitive Flexibility Score in Cognitive Flexibility Inventory
Timepoint
Measurement of Cognitive Flexibility before Intervention and 60 Days after the Onset of Acceptance and Commitment Group Therapy.
Method of measurement
Cognitive Flexibility Inventory

2

Description
Suicide Ideation Score in Suicide Ideation Scale
Timepoint
Measurement of Suicide Ideation before Intervention and 60 Days after the Onset of Acceptance and Commitment Group Therapy.
Method of measurement
Beck Suicide Ideation Scale

3

Description
Beck Hopelessness Score in Hopelessness Scale
Timepoint
Measurement of Hopelessness before Intervention and 60 Days after the Onset of Acceptance and Commitment Group Therapy.
Method of measurement
Beck Hopelessness Scale

4

Description
Depression Score in Beck Depression Inventory-II
Timepoint
Measurement of Depression before Intervention and 60 Days after the Onset of Acceptance and Commitment Group Therapy.
Method of measurement
Beck Depression Inventory-II

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The Intervention group will attend Acceptance and Commitment Group Therapy Sessions for 8 Weeks (8 sessions of two hour). In General, the Treatment Plan for this Group Will be to at Assess Previous Session Homework, Teaching a New Technique and Giving Homework for Future Session.
Category
Behavior

2

Description
Control group: The control group simultaneously (8 two-hour sessions for 8 weeks) will continue usual care plan of the group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Samen Province
Full name of responsible person
Zahra Robati
Street address
Kalantari Hwy
City
Mashhad
Province
Razavi Khorasan
Postal code
9194864361
Phone
+98 51 3892 4330
Fax
+98 51 3892 4330
Email
robati.zahra@yahoo.con
Web page address
https://samen.cfu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Hakim Sabzevari University
Full name of responsible person
Ahmad Farzaneh
Street address
Tohid Shahr, Hakim Sabzevari University
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4441 0104
Fax
+98 51 4401 2607
Email
Research@hsu.ac.ir
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, Hakim Sabzevari University
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
Semnan University
Full name of responsible person
Zahra Robati
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mahdishahr- Darband
City
Semnan
Province
Semnan
Postal code
3564111556
Phone
+98 23 3362 4250
Fax
+98 23 3362 6888
Email
robati.zahra@yahoo.com
Web page address
http://www.semnan.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shareh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tohid Shahr Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617666666
Phone
+98 51 4441 9050
Fax
+98 51 4441 4244
Email
hsharreh@yahoo.com.au
Web page address
http://www.hsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Semnan University
Full name of responsible person
Zahra Robati
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mahdishahr- Darband
City
Semnan
Province
Semnan
Postal code
3564111556
Phone
+98 23 3362 4250
Fax
+98 23 3362 6888
Email
robati.zahra@yahoo.com
Web page address
http://www.semnan.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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