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Core and Psychological Indicators of Chronic Pain, Coping Strategies and Treatment Adherence in the Effectiveness of Acceptance and Commitment Therapy(ACT) and Dialectical Behavior Therapy(DBT) Interventions with and without exercise activities in Substance Dependent Patients with chronic pain

Protocol summary

Study aim
The effect of acceptance and commitment therapy (ACT) and dialectical behavior therapy (DBT) with and without exercise on the essential indicators of pain, catastrophic pain, depression, pain consequences, improvement of coping strategies, patience, pain acceptance, craving and desire to treat substance-dependent men with chronic pain.
Design
In a regular random method, we select three centers: Hayat Dobareh, Taban and Omid from the addiction treatment centers of Zahedan city and take the sample in a targeted manner and using a random table, place the people in 4 intervention groups and one control group.
Settings and conduct
Using tests and clinical interviews, patients are selected and then placed in the centers under the interventions of ACT, DBT and exercise for two months, then the test is performed and two months after the end of the interventions, we measure the effectiveness.
Participants/Inclusion and exclusion criteria
Entry criteria: Being a man, completing detoxification, having pain for 6 months, literacy, age 18 to 55 years, not taking psychotropic drugs and drugs that help control chronic pain, obtaining written consent. Exit criteria: Dissatisfaction, absence of more than two sessions and discontinuation of addiction treatment, creating physical problems during the period that require hospitalization.
Intervention groups
To control chronic pain in this study, we used two intervention groups with ACT(with and without exercise), two intervention groups with DBT(with and without exercise) and a control group that did not receive any intervention.
Main outcome variables
After the study, we expect chronic pain control and a desire to treat patients to improve.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210111050000N1
Registration date: 2021-04-02, 1400/01/13
Registration timing: prospective

Last update: 2021-04-02, 1400/01/13
Update count: 0
Registration date
2021-04-02, 1400/01/13
Registrant information
Name
Abbasali Oveisi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 0323
Email address
abbasali.ovisi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-07, 1400/01/18
Expected recruitment end date
2021-04-15, 1400/01/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Core and Psychological Indicators of Chronic Pain, Coping Strategies and Treatment Adherence in the Effectiveness of Acceptance and Commitment Therapy(ACT) and Dialectical Behavior Therapy(DBT) Interventions with and without exercise activities in Substance Dependent Patients with chronic pain
Public title
The effect of ACT and DBT with and without exercise on the core and psychological indicators of chronic pain and improving adherence to substance abuse
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
They complete the detoxification treatment and stay at the beginning of the maintenance treatment period. Lack of chronic pain due to an obvious problem such as infection or bone fracture and ... No serious psychiatric illness (diagnosis by DSM-5 diagnostic interview) Obtaining a score in the Chronic Pain Diagnosis Questionnaire and confirming the chronic pain by the treating physician They complete the detoxification treatment and stay at the beginning of the maintenance treatment period Do not take psychotropic drugs during interventions Failure to attend other sessions of psychotherapy and the Association of Anonymous Addicts
Exclusion criteria:
Dissatisfaction with continuing to participate in treatment sessions Absence from more than two sessions and discontinuation of addiction treatment Creating physical problems during the period that require hospitalization
Age
From 18 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
From the list of addiction treatment centers for men in Zahedan, select two centers in a cluster method and after a diagnostic interview and test and determine patients suffering from chronic pain,Using a random number table, they were placed in four groups of 15 interventions (ACT with exercise and ACT without exercise) and (DBT with exercise and DBT without exercise) and a group of 15 controls and after performing the pre-test, they were exposed to the effects of variables. We are independent.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Etics committee of Birjand Univercity
Street address
between 6 and 8, Qalanbor Blvd, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816647446
Approval date
2021-02-08, 1399/11/20
Ethics committee reference number
IR.BIRJAND.REC.1399.004

Health conditions studied

1

Description of health condition studied
chronic pain
ICD-10 code
G89.4
ICD-10 code description
Chronic pain syndrome

Primary outcomes

1

Description
Reduce chronic pain
Timepoint
Before the intervention and immediately after the intervention and 2 months after the intervention
Method of measurement
Chronic Pain Case Test.; Asghari Moghadam (1995)

Secondary outcomes

1

Description
Catastrophic reduction of chronic pain
Timepoint
Before the intervention and immediately after the intervention and 2 months after the intervention
Method of measurement
Pain Catastrophe Questionnaire (Sullivan, Bishop and Pewick, 1995)

2

Description
Depression
Timepoint
Before the intervention and immediately after the intervention and 2 months after the intervention
Method of measurement
Center for Epidemiological Studies Short Depression Scale(CES-D)

3

Description
Pain coping strategies
Timepoint
Before the intervention and immediately after the intervention and 2 months after the intervention
Method of measurement
Coping Strategies Questionnaire

4

Description
Chronic Pain Acceptance
Timepoint
Before the intervention and immediately after the intervention and 2 months after the intervention
Method of measurement
Chronic Pain Acceptance Questionnaire

5

Description
Reduce cravings
Timepoint
Before the intervention and immediately after the intervention and 2 months after the intervention
Method of measurement
Craving test (Franken, Hendrix and Vandenbrink, 2002)

6

Description
Readiness to change and adhere to treatment
Timepoint
Before the intervention and immediately after the intervention and 2 months after the intervention
Method of measurement
Scale Stage of Readiness for Change and the Desire to Treat Addiction

Intervention groups

1

Description
Intervention group 1: People who receive acceptance and commitment therapy (ACT) with exercise
Category
Treatment - Other

2

Description
Intervention group 2: People who receive acceptance and commitment therapy (ACT) without exercise
Category
Treatment - Other

3

Description
Intervention group 3: People who receive dialectical behavior therapy (DBT) with exercise.
Category
Treatment - Other

4

Description
Intervention group 4: People who receive dialectical behavior therapy (DBT) without exercise.
Category
Treatment - Other

5

Description
Control group:People who do not receive any intervention
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Residential treatment center Hayate Pack
Full name of responsible person
Arbab Omed
Street address
No. 25., Khorramshahr St.
City
زاهدان
Province
Sistan-va-Balouchestan
Postal code
9817717866
Phone
+98 54 3344 0323
Email
Iranhamoon92@yahoo.com

2

Recruitment center
Name of recruitment center
Residential treatment center Taban
Full name of responsible person
Vosoughi-Mehr Younes
Street address
No. 5., Azadi St
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813653174
Phone
+98 54 3344 0323
Email
abbasaliovisi@yahoo.com

3

Recruitment center
Name of recruitment center
Residential treatment center Omid
Full name of responsible person
shohli-bor Amanolahe
Street address
No, 3.,Tabatabai St.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9796644648
Phone
+98 54 3344 0323
Email
abbasali.ovisi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Aliabadi
Street address
Ayatollah Ghaffari Blvd
City
Birjand
Province
South Khorasan
Postal code
9717411111
Phone
+98 56 3244 9152
Fax
+98 56 3234 5591
Email
info@iaubir.ac.ir
Web page address
http://www.iaubir.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad 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
Islamic Azad University
Full name of responsible person
Abbasali Oveisi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Between 6 and 8.; Qalanbar Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816647446
Phone
+98 54 3344 0323
Email
abbasali.ovisi@gmail.com
Web page address
http://www.iaubir.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Abbasali Oveisi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Between 6 and 8.; Qalanbar Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816647446
Phone
+98 54 3344 0323
Email
abbasali.ovisi@gmail.com
Web page address
http://www.iaubir.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Abbasali oveisi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Between 6 and 8, Qalanbor Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816647446
Phone
+98 54 3344 0323
Email
abbasali.ovisi@gmail.com
Web page address
http://www.iaubir.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After studying, it will be possible to access information related to the main outcome of the research.
When the data will become available and for how long
One year after the results are published
To whom data/document is available
Students, professors, researchers and clinicians
Under which criteria data/document could be used
Data should be requested with the aim of improving the level of research or clinical interventions.
From where data/document is obtainable
postal code 9816647446,No.,6, Qalanbar Blv, Zahedan city abbasali.ovisi@gmail.com
What processes are involved for a request to access data/document
The request will be sent by e-mail and will be answered within one month after receiving the request.
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