Protocol summary

Summary
1-Objectives: To study the effectiveness of the Acceptance and Commitment Therapy (ACT) techniques in lessening draftees’ depression and honing their quality of life and psychological resilience. 2-Design: The present study, as a two-month follow-up with two experimental groups and waiting lists, was a randomized controlled clinical trial with pre and post-test execution modes. 3-Methodology: The Beck Depression Inventory (BDI) was administered to 419 draftees, and 124 draftees received scores higher than the cut-off point (14 and above). In addition, 11 draftees were excluded from the study due to the lack of inclusion criteria. Also, of the remaining 113 draftees, 40 of them were randomly selected and assigned to two groups (n=20) and waiting list (n=20). 4-Participants: draftees suffering from the symptoms of depression. 5-interventions: To this end, six sessions of the Acceptance and Commitment Therapy (ACT) techniques were administered to the draftees (one personal session and five group sessions). 6-The main outcome variables: symptoms of depression, psychological resilience, quality of life 6-main outcome measures (variables): symptoms of depression, psychological resilience, quality of life

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016112731138N1
Registration date: 2017-02-15, 1395/11/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-15, 1395/11/27
Registrant information
Name
HamidReza Shekari
Name of organization / entity
AJA Medical University
Country
Iran (Islamic Republic of)
Phone
+98 83 3838 3215
Email address
hamidreza.shekari35@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research, Aja University Of Medical Sciences
Expected recruitment start date
2015-04-09, 1394/01/20
Expected recruitment end date
2015-05-18, 1394/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness Of Group Training Techniques Acceptance And Commitment Therapy (ACT) On Depressive Symptoms, Quality Of Life And Psychological Flexibility Soldiers
Public title
Acceptance And Commitment Therapy Effectiveness Of On Depression, Quality Of Life And Psychological Flexibility Soldiers
Purpose
Treatment
Inclusion/Exclusion criteria
The Inclusion Criteria: To be in the 18-25 age range؛ a minimum education of 7th grade and a maximum of 12th grade؛ physical ability to participate in the study؛ receiving a score higher than the cut-off point (14 and above) on the Beck Depression Inventory (BDI). The Exclusion Criteria: The draftees who were seeking conscription medical exemptions؛ those who were on the transfer list؛ those who had three months left from their military service؛ those who were addicted to narcotics؛ those who were on medication or psychological treatment (the last item was determined through interviews and checking the medical records of draftees in the battalion).
Age
From 18 years old to 25 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

2

Registry name
-
Secondary trial Id
-
Registration date
empty

3

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical University AJA Ethics Committee
Street address
Street Etemadzadeh, Fatemi Street, Tehran
City
Tehran
Postal code
Approval date
2015-03-16, 1393/12/25
Ethics committee reference number
IR.AJAUMS.REC.1395.25

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
f32.0
ICD-10 code description
Two Or Three Of The Above Symptoms Are Usually Present. The Patient Is Usually Distressed By These But Will Probably Be Able To Continue With Most Activities.

Primary outcomes

1

Description
Symptoms Of Depression
Timepoint
A week prior to the intervention, after the last session of the intervention (45 days after the first session), two months after the last session
Method of measurement
21-Question Beck Depression Inventory Form

Secondary outcomes

1

Description
Psychological Flexibility
Timepoint
A week prior to the intervention, after the last session of the intervention (45 days after the first session), two months after the last session
Method of measurement
The Second Version Of The Questionnaire Of 10 Questions, Accepting External Action

2

Description
Quality Of Life
Timepoint
A week prior to the intervention, after the last session of the intervention (45 days after the first session), two months after the last session
Method of measurement
36-Item Quality Of Life Questionnaire (SF-36)

Intervention groups

1

Description
Acceptance and Commitment Therapy is a mental therapeutics third wave of cognitive-behavioral therapy in individual and group meetings and number of meetings held with a range of 4 to 12 sessions. Given that our soldiers environments with patients with mental disorders face and being outdoors widely according to the mission and specific circumstances of the individual is prone to psychological disorders, In this environment the use of training group psychotherapy can be effective in terms of time and cost. In this study experimental groups of 6 training sessions per protocol Acceptance and Commitment Therapy techniques, just a week sessions (total 45 days), the first session (individual and 30-60 minutes), 5 the next meeting (group and 60-120 minutes) run respectively. Therapist and clinical supervisor in the workshop under the supervision of the treatment period has passed.
Category
Prevention

2

Description
By the end of the two-month follow-up, no intervention was administered to the waiting list. After the two-month follow-up period, six sessions of the Acceptance and Commitment Therapy (ACT) techniques were administered to the waiting list for observing the ethical issues.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical University Aja
Full name of responsible person
Doctor Pervez Dabbaghi
Street address
Department Of Psychology, Medical School Medical University AJA, Etemadzadeh street, Fatemi Avenue, Tehran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor For Research, Aja University Of Medical Sciences
Full name of responsible person
Doctor Kamran Azma
Street address
Vice Chancellor For Research And Technology, Etemadzadeh Street, Fatemi Av, Tehran.
City
Tehran
Grant name
111230
Grant code / Reference number
1103001001/2184
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research, Aja 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
Baqiyatallah University Of Medical Sciences
Full name of responsible person
Doctor Behnaz Dowran
Position
PhD In Psychology
Other areas of specialty/work
Street address
Department Of Psychology, Faculty Of Medicine, Baqiyatallah University Of Medical Sciences, Mulla Sadra Avenue, Tehran
City
Tehran
Postal code
Phone
+98 912 418 6389
Fax
+98 912 418 6389
Email
dowranb@hotmail.com
Web page address
www.bmsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Medical University Aja
Full name of responsible person
doctor Parviz Dabbaghi
Position
Doctor Of Clinical Psychology
Other areas of specialty/work
Street address
Department Of Psychology, Faculty Of Medicine, Etemadzadeh Street, Fatemi Av, Tehran.
City
Tehran
Postal code
Phone
+98 912 287 6554
Fax
+98 912 287 6554
Email
dabaghi_44@yahoo.com
Web page address
Aja University Of Medical Science

Person responsible for updating data

Contact
Name of organization / entity
Medical University Aja
Full name of responsible person
HamidReza Shekari
Position
Master Of Clinical Psychology
Other areas of specialty/work
Street address
Unit 67, 5th Floor, Block A3, Complex 1, Town General Najafi, Kermanshah.
City
Kermanshah
Postal code
6719681847
Phone
+98 83 3838 3215
Fax
+98 83 3838 3215
Email
hamidreza.shekari35@gmail.com
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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