Protocol summary

Study aim
The main purpose of this study was to compare the effectiveness of compassion-based emotion therapy package with compassion-based therapy on the quality of life of patients with primary headache symptoms.
Design
This research is a three-group quasi-experimental method with pre-test-post-test design and follow-up with a control group. The statistical population was all patients with symptoms of primary headache referred to the clinic of Khatam Al-Anbia Hospital in Tehran in the winter of 1399 in the ages of 18 to 45 years, from which 45 patients were purposefully selected. After purposeful selection of sample members, randomly selected individuals were divided into three groups of 15 people (in quasi-experimental research, at least 15 people are recommended for each group). After sampling, the subjects were divided into two experimental groups and one control group
Settings and conduct
The statistical population was all patients with symptoms of primary headache referred to the clinic of Khatam Al-Anbia Hospital in Tehran in the winter of 1399 in the ages of 18 to 45 years, from which 45 patients were purposefully selected. After purposeful selection of sample members, randomly selected individuals were divided into three groups of 15 people (in quasi-experimental research, at least 15 people are recommended for each group).
Participants/Inclusion and exclusion criteria
Inclusion criteria: informed consent for treatment, being in the age group of 18 to 45 years, high score in the quality of life scale, diagnosis of primary headache by a specialist and having a file, are not under parallel psychiatric and psychological treatments
Intervention groups
The first experimental group was the compassion-based emotion therapy group The second experimental group was the compassion-based treatment group The third control group
Main outcome variables
Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210901052355N1
Registration date: 2021-10-13, 1400/07/21
Registration timing: registered_while_recruiting

Last update: 2021-10-13, 1400/07/21
Update count: 0
Registration date
2021-10-13, 1400/07/21
Registrant information
Name
neda behvandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3500 2612
Email address
nedabehvandy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-19, 1400/06/28
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of compassion-based emotion-focused combination therapy package with compassion-based therapy on quality of life in patients with primary headache symptoms
Public title
Comparison of the effectiveness of compassion-based emotion-focused combination therapy package with compassion-based therapy on quality of life in patients with primary headache symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious satisfaction of the subjects and willingness to participate and continue to participate in treatment Being in the age group of 18 to 45 years according to the disability assessment questionnaire caused by headache Diagnosis of primary headache by a specialist and having a record Do not undergo parallel psychiatric and psychological treatments
Exclusion criteria:
Dissatisfaction and unwillingness to participate and continue to participate in treatment Do have secondary headaches Absence of three consecutive or non-consecutive sessions Undergo other psychiatric and psychological treatments.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
45 patients from the community of patients with primary headache symptoms of Khatam Al-Anbia Hospital will be purposefully selected based on sample adequacy (Sarmad, Hejazi and Bazargan, (1997) in experimental and quasi-experimental research recommend at least 15 to 20 people for each group). The assignment of both experimental groups, including compassion-based emotion therapy and compassion-based therapy, and the control group will be a simple random lottery. In this way, each sample person is given a special code and then the codes are poured into a bag or container and mixed. It then pulls out the codes one by one, writes down their number, and so on until the groups are completed. Then, for random and unpredictable allocation of 15 people in the first, second and third groups for two experimental groups and one control group, coin toss will be used.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is a three-way blind. In this study, three sample groups, treatment administrators and an evaluation group that analyzed the obtained data, were kept blind. In this study, the facilitator, participants, treatment executives, and the assessment team did not already have any knowledge or physical, telephone, or online contact with each other. In this study, three groups of samples are kept blind to each other and to the treatment. Also, the executors of the treatments and the information evaluation team are outside the treatment plan team
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University
Street address
University Blvd, Arqavanieh, Jey Street, Isfahan Azad University
City
Isfahan
Province
Isfehan
Postal code
۳۹۹۹۸-۸۱۵۵۱
Approval date
2020-06-10, 1399/03/21
Ethics committee reference number
IR.IAU.KHUISF.REC.1399.063

Health conditions studied

1

Description of health condition studied
Primary headache
ICD-10 code
G43؛ G44.2
ICD-10 code description
Migraine؛ Tension type headache؛ Cluster headache syndrome

Primary outcomes

1

Description
In the present study, the outcome variable is a quality of life score below 40 in the Quality of Ware & Sherbourne Questionnaire, which indicates a low quality of life.
Timepoint
Before the intervention and 80 days later (completion of the intervention) and then 60 days later (follow-up)
Method of measurement
The tool for measuring the outcome variable is the quality of Life Ware & Sherbourne Questionnaire. The quality of life variable is measured in three stages before the intervention, after the intervention (80 days after the start of the intervention) and in the follow-up stage (60 days after the end of the intervention). In the instrument of measuring the quality of life Ware & Sherbourne , the maximum scores are 100 and the minimum scores are zero. High scores mean high quality of life and low scores mean low quality of life.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1:Emotion-based therapy group is based on compassion. The experimental group or the first intervention received compassion-based emotion therapy therapy for 10 sessions one day a week for 60 minutes. The first group intervention based on the protocol developed by Behvandi, Khayatan and Golparvar (1399) based on the need-based inductive thematic analysis (theme) (based on the needs of patients with primary headache symptoms) and interviews with patients with symptoms Initial headache, then adaptation of needs to emotion-based and compassionate treatment texts, and finally obtaining specialized agreement and approval of initial executive preparation were prepared. The content of emotion-based therapy includes: 1. Creating awareness, regulation and emotional transformation as three principles of emotional change 2. Intervening in disturbances to deal with emotions and 3. Cultivating compassion and soothing system in patients with early headache symptoms Help
Category
Behavior

2

Description
Intervention group2: The treatment group is based on compassion. The experimental group or the second intervention received compassion-based treatment for 8 sessions one day a week for 60 minutes. Compassion therapy sessions were prepared based on the validated and tested protocol of Gilbert (2010). The content of compassion-based sessions includes: introduction to emotional regulation systems, familiarity with the conscious brain, familiarity with the characteristics of compassion and cognition of the compassionate person, compassionate reasoning and compassionate attention, compassionate visualization and compassionate sensory experience, compassionate feeling and compassionate behavior
Category
Behavior

3

Description
Control group: without receiving any treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam Al Anbia Hospital
Full name of responsible person
Felor Khayatan
Street address
University Blvd, Arqavanieh., Jey Street., Isfahan Azad University
City
Isfahan
Province
Isfehan
Postal code
۳۹۹۹۸-۸۱۵۵۱
Phone
+98 31 3500 2612
Email
NedaBehvandy@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Hadi Farhadi
Street address
University Blvd, Arqavanieh, Jey Street, Isfahan Azad University
City
Isfahan
Province
Isfehan
Postal code
۳۹۹۹۸-۸۱۵۵۱
Phone
+98 31 3500 2612
Email
FarhadiHadi@yahoo.com
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
Private
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
Isfahan Azad University
Full name of responsible person
Dr.Felor Khayatan
Position
Assistant Professor, Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University Blvd, Arqavanieh, Jey Street, Isfahan Azad University
City
Isfahan
Province
Isfehan
Postal code
۳۹۹۹۸-۸۱۵۵۱
Phone
+98 913 128 9531
Email
F.khayatan@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan Azad University
Full name of responsible person
Dr.Felor Khayatan
Position
Assistant، Professor Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Isfahan Azad University
City
Isfahan
Province
Isfehan
Postal code
۳۹۹۹۸-۸۱۵۵۱
Phone
+98 913 128 9531
Email
F.Khayatan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Felor Khayatan
Position
Assistant Professor, Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University Blvd, Arqavanieh, Jey Street, Isfahan Azad University
City
Isfahan
Province
Isfehan
Postal code
۳۹۹۹۸-۸۱۵۵۱
Phone
+98 31 3500 1226
Email
F.Khayatan@yahoo.com

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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Dissemination of information at the individual or private level: For each of the participants in the present study, the files related to that person and also the main outcome of the study in which the person participated are prepared as a personal file and if requested as a CD file or email Will be provided to them. Dissemination of information at the public level: The results of the present study will be published in the form of articles, lectures and other forms of public media in the form of identifiable information and maintaining the confidentiality and privacy of study participants
When the data will become available and for how long
Access to the data will start 4 months after the results are published and in 1400
To whom data/document is available
Anyone interested in psychological studies in the field of headache and its symptoms can benefit from the information published in this study. Researchers and students with studies related to the present study, if they need more information about the research process and more information about the results obtained, can be informed through the email address and phone number of the responsible author
Under which criteria data/document could be used
1.Researchers and researchers can refer to the present study by citing the source 2. Researchers and researchers can compare the treatments used in the present study with other studies by mentioning the reference or by referring to the reference as a new protocol
From where data/document is obtainable
Applicants can refer to the following e-mail address and contact numbers to receive the required documents or data. F.khayatan@yahoo.com; Nedabehvandy@gmail.com 09131289531 09902175301 09388481122 031- 35002612
What processes are involved for a request to access data/document
1. Sending an official e-mail or telephone call requesting a respectful and formal request on the subject of the research requesting the documents and the reason for the need for the documents 2. Receive valid details from the applicant for documents, including complete and valid personal details, valid email address, valid contact number to verify the validity of the request of the document applicant 3.Check emails and calls within 48 hours and if the request of the applicant is confirmed, send the documents while maintaining the privacy and confidentiality in the form of email, fax and post for the applicant
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