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The effectiveness of Acceptance and Commitment Therapy (ACT) compared with Cognitive Behavior Therapy (CBT) on quality of life in patients with chronic low back pain

Protocol summary

Summary
The purpose of this study is to evaluate the impact of Acceptance and Commitment Therapy (ACT) compared with Cognitive Behavior Therapy (CBT) on quality of life in patients with chronic low back pain. For this purpose, according to chronic pain criteria and other inclusion criteria, such as having 18 to 50 years, do not using any treatment (other than medication) during the intervention period and willingness to participate in the study and finally, after diagnosis by pain specialist, 45 patients with chronic low back pain select by purposive sampling from patients referred to a pain clinic in Akhtar Hospital. Then, they are randomly (using lottery) assigned to the ACT (15 patients), CBT (15 patients) and control (15 patients) group. In acceptance and commitment therapy, in order to enhance quality of life in patient, focus on their psychological flexibility and commitment to the implementation of the value of their lives. The cognitive and behavioral therapy, in order to enhance the quality of life in patients, focus on the challenge with thoughts and exposure and in control group do not implement any intervention. Quality of Life Questionnaire conduct in the three groups at pretest and posttest, and finally, after the interventions, results of the groups compare with together.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014092615577N2
Registration date: 2014-12-25, 1393/10/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-25, 1393/10/04
Registrant information
Name
Soheila Ghomian
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 3627 0702
Email address
ghomian_s@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mental Health Research Center, Tehran Institute of Psychiatry
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Acceptance and Commitment Therapy (ACT) compared with Cognitive Behavior Therapy (CBT) on quality of life in patients with chronic low back pain
Public title
The comparison of ACT and CBT effectiveness on chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having criteria for chronic low back pain according to pain specialist diagnosis; having 18 to 50 years; do not using any treatment (other than medication) during the intervention period; willingness to participate in the study. Exclusion criteria: Not meet the listed conditions and comorbidity with mental disorders using the MCMI-III questionnaire.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Tehran Institute of Psychiatry,Iran University of Medical Sciences, No. 1, Mansouri martyr Street, Worship Street, Sattarkhan Street, Tehran, Iran.
City
Tehran
Postal code
Approval date
2014-09-22, 1393/06/31
Ethics committee reference number
24859

Health conditions studied

1

Description of health condition studied
Chronic back pain
ICD-10 code
M54.5
ICD-10 code description
Loin pain, Low back strain, Lumbago NOS

Primary outcomes

1

Description
Quality of life
Timepoint
Before the intervention, after the intervention
Method of measurement
Quality of life Questionnare

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Cognitive behavior therapy (CBT) for chronic pain is a 11 sessions (11 weeks) group therapy program. The sessions include: Session 1: Learning about chronic pain; Session 2: Theories of pain and abdominal breathing; Session 3: Progressive muscle relaxation and visual imagery; Session 4: Automatic thoughts and pain; Session 5: Cognitive restructuring; Session 6: Stress managing; Session 7: Scheduler activity; Session 8: Planning a pleasant activity; Session 9: Anger management; Session 10: Sleep Health; Session 11: The prevention of relapse and recurrence of pain
Category
Behavior

2

Description
Intervention group: ACT is a 8 week group therapy program, with sessions of 2 hours per week. Treatment sessions is based on ACT protocol for chronic pain. In general, the content of the sessions is as follows: Session 1: Meeting members with together and introducing treatment sessions; Session 2: Evaluating of potential values of clients, introducing the model of behavior and concept of behavior change and practice of mindfulness; Session 3: Clarificating of the concept of acceptance, determining the values and practice of mindfulness; Session 4: Clarificating the values and necessary goals to achieve them, clarificating the barriers to access them, introducing the committed behavior and practice of mindfulness; Session 5: Practicing the defusioin (detachment from painful thoughts and feelings) and practice of mindfulness; Session 6: Clarificating the committed behavior and practice of mindfulness; Session 7: Evaluating primary and secondary suffering, commitment and barriers to achieve the acceptance and practice of mindfulness; Session 8: Review the values, checking recurrence and goodbye.
Category
Behavior

3

Description
Control group: The control group receive routine medical treatment in hospital.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Akhtar Hospital Pain Clinic
Full name of responsible person
Dr. Masud Hashemi
Street address
Akhtar Hospital Pain Clinic, Sharifi Manesh Street, Rumi Poul, Shariati Street, Tehran, Iran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Mental Health Research Center, Iran University of Medical Sciences
Full name of responsible person
Dr.Vahid Shariat
Street address
Tehran Institute of Psychiatry, Iran University of Medical Sciences, No. 1, Mansouri martyr Street, Worship Street, Sattarkhan Street, Tehran, Iran
City
Tehran
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 Mental Health Research Center, Iran 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
Tehran Institute of Psychiatry
Full name of responsible person
Dr. Ali Asghar Asghar nejad
Position
PhD in Clinical Psychology/ Assistant Professor
Other areas of specialty/work
Street address
Tehran Institute of Psychiatry, Iran University of Medical Sciences, No. 1, Mansouri martyr Street, Worship Street, Sattarkhan Street, Tehran, Iran
City
Tehran
Postal code
Phone
00
Fax
Email
Asgharnejad.ali@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Soheila Ghomian
Position
PhD Student in Clinical Psychology
Other areas of specialty/work
Street address
Shahed University, In front of Shrine, Persian Gulf Freeway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 3627 0702
Fax
Email
Ghomian_s@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Soheila Ghomian
Position
PhD Student in clinical psychology
Other areas of specialty/work
Street address
Shahed University, In front of Shrine, Persian Gulf Freeway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 3627 0702
Fax
Email
Ghomian_s@yahoo. 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
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