1. Home
  2. Approved trials
  3. » فارسی

The effectiveness of Acceptance & Commitment Therapy on cognitive emotion regulation strategies, Anxiety, Depression, Headache Disability and Headache intensity in patients with Chronic Daily Headache

Protocol summary

Summary
The purpose of this study was to investigate the effects of Acceptance and Commitment Therapy on cognitive emotion regulation strategies, Anxiety, Depression, headache disability and headache intensity among patients with chronic daily headache. The study is one-centered, non-blinded, and two-grouped. The population of this study is comprised of all adults with chronic daily headache, referring to the neurology clinic of the Shahid Beheshti Hospital of Kashan City, during 2016. A total of 40 patients selected as the study sample and assigned into intervention and control groups by block randomization method (20 participants in each group). Inclusion criteria include having chronic daily headache according to the International Classification of Headache Disorders, 3rd edition; informed consent to participate in the study and having old above 18. Major exclusion criteria include unwillingness to continue participation; having a medical diagnosis of organic brain disorder or psy-chotic disorder, having a history of psychological treatment during the preceding six months. The intervention group was trained for eight 90-min weekly group sessions. Cognitive emotion regulation Questionnaire (CERQ), Depression anxiety stress scale (DASS-21), Diary scale for headache and Headache related disability inventory (HDI) have administered at pretreatment and post-treatment in both groups. By comparing the mean scores of the two groups, the effectiveness of Acceptance and Commitment Therapy on cognitive emotion regulation strategies, Anxiety, Depression, headache disability and headache intensity determines in patients with chronic daily headache.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017091236145N1
Registration date: 2017-11-20, 1396/08/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-20, 1396/08/29
Registrant information
Name
Hassan Khazraee
Name of organization / entity
Kashan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 2291 6590
Email address
khazraee-ha@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical science
Expected recruitment start date
2016-12-20, 1395/09/30
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Acceptance & Commitment Therapy on cognitive emotion regulation strategies, Anxiety, Depression, Headache Disability and Headache intensity in patients with Chronic Daily Headache
Public title
The effectiveness of Acceptance & Commitment Therapy on cognitive emotion regulation strategies, Anxiety, Depression, Headache Disability and Headache intensity in patients with Chronic Daily Headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: having chronic daily headache according to the International Classification of Headache Disorders, 3rd edition (beta version), and tending to participate in the study exclusion criteria included: having a medical diagnosis of organic brain disorder or psychotic disorder and having a history of psychological treatments during the preceding six months.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
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
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Qotb-e Ravandi Blvd
City
Kashan
Postal code
Approval date
2017-10-17, 1396/07/25
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.53

Health conditions studied

1

Description of health condition studied
Chronic Daily Headache
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
cognitive emotion regulation strategies
Timepoint
pretreatment and posttreatment
Method of measurement
cognitive emotion regulation strategies (CERQ)

2

Description
depression and anxiety
Timepoint
pretreatment and posttreatment
Method of measurement
DASS-21 scale

3

Description
headache disability
Timepoint
pretreatment and 2 months after treatment
Method of measurement
headache disability inventory (HDI)

4

Description
headache intensity
Timepoint
pretreatment and 2 months after treatment
Method of measurement
diary scale of headache

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group (Acceptance and Commitment Therapy): Completion of Cognitive emotion regulation Questionnaire (CERQ), Depression anxiety stress scale (DASS-21), Diary scale for headache and Headache related disability inventory (HDI) before intervention; going through 8 sessions of Acceptance and Commitment Therapy training one session a week; completion of Questionnaires after intervention.
Category
Behavior

2

Description
Control Group (No intervention): Completion of Cognitive emotion regulation Questionnaire (CERQ), Depression anxiety stress scale (DASS-21), Diary scale for headache and Headache related disability inventory (HDI) before intervention; no intervention; completion of Questionnaires after intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
neurology clinic of Shahid Beheshti Hospital of Kashan City
Full name of responsible person
Dr Reza Daneshvar Kakhki (neurologist)
Street address
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
research committee
Street address
Qotb-e 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
Kashan 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
Kashan university of medical science
Full name of responsible person
Dr zanjani
Position
PHD/ science Committee of clinical psychology
Other areas of specialty/work
Street address
Qotb-e Ravandi Blvd
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
z_zanjani2005@yahoo.com research@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan university of medical science
Full name of responsible person
Hassan Khazraee
Position
Master Degree
Other areas of specialty/work
Street address
Qotb-e Ravandi Blvd
City
Kashan
Postal code
1916658868
Phone
+98 21 2291 6590
Fax
Email
hassankhazraee@gmail.com Khazraee-ha@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan university of medical science
Full name of responsible person
Hassan Khazraee
Position
Master degree
Other areas of specialty/work
Street address
Qotb-e Ravandi Blvd
City
Kashan
Postal code
Phone
00
Fax
Email
hassankhazraee@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
Loading...