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Controlled trial of effectiveness of Acceptance and Commitment Therapy on depression, anxiety, risky decision making, craving and cessation in male smokers.

Protocol summary

Summary
(1) Objectives: This study aims at investigating the effectiveness of acceptance and commitment therapy on smoker's depression, anxiety, risky decision making, craving and cessation at Kashan. (2) Design: This is a pretest-posttest experimental study. The intervention also includes a six-weeks follow-up course.(3) Methods: A sample of 70 eligible male smokers will be recruited. That will be randomly allocated to either the experimental or the control groups. smokers in the experimental group will receive acceptance and commitment therapy while the smokers in the control group will receive Treatment As Usual(TAU) in smoking cessation clinics. Study instruments include the Beck Depression inventory, the Beck Anxiety Inventory, and Iowa gambling test, fagestrom and exhaled CO2 detector. These instruments will be completed before, immediately after, and one month after the intervention. (4) Inclusion Criterias: 1. Having an age of 18–40 years, 2.Having a degree in secondary education or higher, 3.nicotine dependence based on DSM 5 diagnostic criterias. (5 )exclusion criterias:1.Having a known-cause depression or anxiety following problems such as loss, marital conflicts and divorce, 2.Having a history of psychotic disorders, 3.Receiving psychotherapy or drug therapy during past six months, 4.Unwillingness to continue participating in the study , 5.Failing to participate in more than two sessions of the study intervention 6.Having a history of substance abuse disorders; (6)Intervention: The intervention of this study is acceptance and commitment therapy which includes eight 90-minute sessions. (7) Primary outcomes: The primary outcomes are depression, anxiety, risky decision making, craving and cessation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011932057N1
Registration date: 2017-06-19, 1396/03/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-19, 1396/03/29
Registrant information
Name
Mohamad Reza Davoudi
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 2999
Email address
davoudi-mr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Kashan University of Medical Sciences and Health Services
Expected recruitment start date
2017-02-03, 1395/11/15
Expected recruitment end date
2017-02-08, 1395/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Controlled trial of effectiveness of Acceptance and Commitment Therapy on depression, anxiety, risky decision making, craving and cessation in male smokers.
Public title
Effectiveness Of Acceptance and Commitment Therapy on male smokers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1.Having an age of 18–40 years, 2.Having a degree in secondary education or higher, 3.nicotine dependence based on DSM 5 diagnostic criteria exclusion criteria:1.Having a known-cause depression or anxiety following problems such as loss, marital conflicts and divorce, 2.Having a history of psychotic disorders, 3.Receiving psychotherapy or drug therapy during past six months, 4.Unwillingness to continue participating in the study , 5.Failing to participate in more than two sessions of the study intervention 6.Had a history of substance abuse disorders;
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: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The population consisted of all male smokers admitted to center treatment of drug abuse and smoking in Kargrnzhad psychiatric hospital. from all participation's that meets inclusion criteria,35 participants for each group selected by Random assignment will be done,that by the use of computer-generated random numbers. intervention duration is six weeks. one week after intervention, post-test data is collecting. six weeks later follow-up data was measured.pre-test data is done by the investigator prior to the intervention.intervention duration is six weeks. one week after intervention, post-test data is collecting. six weeks later follow-up data was measured.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of kashan University of Medical Sciences
Street address
Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd
City
kashan
Postal code
8715988141
Approval date
2016-12-08, 1395/09/18
Ethics committee reference number
ir.kaums.rec.1395.103

Health conditions studied

1

Description of health condition studied
nicotine dependence
ICD-10 code
F17
ICD-10 code description
Mental and behavioural disorders due to use of tobacco

2

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.

3

Description of health condition studied
anxiety
ICD-10 code
F49.1
ICD-10 code description
Anxiety NOS

Primary outcomes

1

Description
depression
Timepoint
Before intervention, After intervention, One month after intervention
Method of measurement
Beck depression inventory

2

Description
anxiety
Timepoint
Before intervention, After intervention, One month after intervention
Method of measurement
Beck Anxiety Inventory

3

Description
craving(nicotine dependence)
Timepoint
Before intervention, After intervention, One month after intervention
Method of measurement
fagestrom Craving scale

4

Description
Risky decision making
Timepoint
Before intervention, After intervention, One month after intervention
Method of measurement
Iowa gambling test

5

Description
smoking cessation
Timepoint
Before intervention, After intervention, One month after intervention
Method of measurement
Expiratory CO2 concentration

Secondary outcomes

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Intervention groups

1

Description
Intervention group: This study is conducted to determine the effectiveness of Acceptance and Commitment Therapy (ACT) on depression, anxiety, risky decision making, craving and cessation in male smokers . The aim of this approach is invites people to open up to unpleasant feelings, and learn not to overreact to them, and not avoiding situations where they are invoked. Its therapeutic effect is a positive spiral where feeling better leads to a better understanding of the truth and also experienced flexible life. this treatment is during the eight 90-minute sessions for two months.
Category
Behavior

2

Description
Control Group: This group will receive behavioral interventions for smoking cessation that approved by the Ministry of Health of Iran that is used for the smoking cessation centers and based on the psych-education and motivational interview.this protocol like intervention group during the eight 90-minute sessions for two months.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Kargarnejad Psychiatric Hospital
Full name of responsible person
MD.Fateme Sadat Ghoreyshi
Street address
Kargarnejad psychiatric Hospital, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Kashan University of Medical Sciences and Health Services
Full name of responsible person
Dr Qolam Ali Hamidi
Street address
Vice chancellor for research of Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd
City
kashan
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 of Kashan University of Medical Sciences and Health Services
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
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Mohammadreza Davoudi
Position
M.Sc candidate in clinical psychology
Other areas of specialty/work
Street address
Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd
City
kashan
Postal code
Phone
+98 31 5554 9111
Fax
Email
davoudi-mr@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Mohamad reza Davoudi
Position
M.Sc candidate in clinical psychology
Other areas of specialty/work
Street address
Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd
City
kashan
Postal code
Phone
+98 31 5554 9111
Fax
Email
davoudi-mr@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Maohamadreza davoudi
Position
M.Sc candidate in clinical psychology
Other areas of specialty/work
Street address
Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd
City
kashan
Postal code
Phone
+98 31 5554 9111
Fax
Email
davoudi-mr@kaums.ac.ir
Web page address

Sharing plan

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