Protocol summary

Study aim
Determining the effectiveness of therapy based on acceptance and commitment on reducing the symptoms of grief, coronavirus anxiety and improving the quality of life
Design
A Clinical Trial with a Control Group, Randomized using a table of random numbers, on 38 Patients. No blinding was done.
Settings and conduct
After receiving the code of ethics from the ethics committee of Shahid Beheshti University of Medical Sciences, the sample people are selected based on the entry and exit criteria in the city of Tehran, the psychology clinic of Taleghani Hospital in Tehran, and then after the initial interview according to SCID and declaring their willingness to participate in the meetings, they will be given explanations about the research and written consent will be obtained from them and they will be assured that the participation in the study is voluntary and the participants can leave the study at any time.
Participants/Inclusion and exclusion criteria
The criteria for entering the patient into the research include: Bereaved people who lost one of their loved ones due to corona and at least 3 months have passed since their death. to mourn naturally), be 18 years old or older The criteria for excluding patients from the study include: the presence of concurrent mental disorders such as bipolar disorders and related disorders, schizophrenia spectrum disorders and other psychotic disorders, addictive disorders and substance-related disorders, organic brain disorders based on the family and patient reports.
Intervention groups
Intervention group: ten 120-minute group therapy sessions based on acceptance and commitment will be implemented based on Steven Hayes's theory presented in the book. Therapy Based on Acceptance and commitment Presentation. Control group: no treatment
Main outcome variables
symptoms grief, coronavirus anxiety, Quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230219057460N1
Registration date: 2023-03-02, 1401/12/11
Registration timing: prospective

Last update: 2023-03-02, 1401/12/11
Update count: 0
Registration date
2023-03-02, 1401/12/11
Registrant information
Name
emad alkasir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 6662
Email address
emadalkasir@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-30, 1402/02/10
Expected recruitment end date
2023-11-01, 1402/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Acceptance and Commitment Therapy On reducing grief symptoms, coronavirus anxiety and improving the quality of life
Public title
The Effectiveness of Acceptance and Commitment Therapy On reducing grief symptoms, coronavirus anxiety and improving the quality of life
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Bereaved people who have lost a loved one and at least 3 months have passed since their death Be 18 years old or older
Exclusion criteria:
The presence of concurrent mental disorders such as bipolar disorders and related disorders, schizophrenia spectrum disorders and other psychotic disorders, addictive disorders and substance-related disorders Organic brain disorder based on the report of the family and the patient herself
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 38
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be simple randomization. The randomization unit is individual. At first, the names of the participants will be collected as a set of numbers, without any particular pattern or order, and completely randomly generated in advance, and these numbers will be used to categorize different groups, in such a way that the even numbers in the group Intervention and individual numbers will be placed in the control group.Even numbers in the intervention group and individual numbers will be in the control group.
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
Research Ethics Committees of School of Medicine - Shahid Beheshti University of Medical Sciences
Street address
Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2021-08-03, 1400/05/12
Ethics committee reference number
IR.SBMU.MSP.REC.1400.260

Health conditions studied

1

Description of health condition studied
coronavirus anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

Primary outcomes

1

Description
Corona anxiety score in the Corona Anxiety Questionnaire
Timepoint
At the beginning of the study (before the start of the intervention), after the end of the intervention
Method of measurement
Corona Anxiety Questionnaire Alipour et al (2019)

2

Description
Grief score on the Complex Grief Scale (ICG)
Timepoint
At the beginning of the study (before the start of the intervention), after the end of the intervention
Method of measurement
Grief Questionnaire of Prigerson and Maciejewski (1995)

3

Description
Quality of life score in the short form of the World Health Organization Quality of Life Scale (WHOQOL-BRIEF)
Timepoint
At the beginning of the study (before the start of the intervention), after the end of the intervention
Method of measurement
Purba et al. quality of life questionnaire(2018)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The experimental group will receive 10 sessions of 2 hours (120 minutes) during 10 weekly sessions. Session 1 :Assessment and Evaluation: recognize and identify the type of grief, comorbidity and Definition of Grief, Stages of Grief, Grief resolved to unresolved grief Understanding Acceptance and Commitment Therapy, the obligation to accept and carry out assignments and participate in group and individual Session 2: Pain, suffering, struggle and avoidance, Acceptance, Review coping strategies and control Creative Hopelessness, Explain and discuss the impact of control• explain the willingness Session 3: discuss the nature of automatic thoughts Creative Hopelessness, Exercise prayer, Do not think of exercise (chocolate donut metaphor)How the mind works, chatter, machine words, pop up mind Acceptance thoughts, versus Avoidance. Session 4: Talk about the experience of emotions, Emotional appeals emotions Bdaynd, creative Hopelessness (control)Happiness trap, Marriage Practices, Relationships between emotions, Talk about anger Presentation given mindfulness training (as a substitute for emotional control), practice of mindful breathing, Acceptance of emotions versus avoidance (rejection) Session 5-7: mindfulness training completed, Exercise: Walk quietly, Practice: tea, Practice: mindful Eating Introduction to Cognitive defusion Practice: The word "milk "The pronunciation of poetry readings It is very slow to tell With different voices to tell Bad News Radio. Session 8-10: Complete discussion, willingness, Introduction values, evaluate the values, the selection of values, Targets, Commitment, completion of discussion and follow up
Category
Treatment - Other

2

Description
Control group: No Treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Abbas Masjedi Arani
Street address
Iran, Tehran Velenjak St. Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
taleghanihospital@sbmu.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Vice President of Research and Technology of the University,Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 23871
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Masjedi Arani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 23871
Email
a.masjediarani@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Bakhtiyari
Position
Full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 23871
Email
maryam_.bakhtiyari@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Emad Alkasir
Position
Phd.Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 23871
Email
emadalkasir@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The main report of the clinical study will be published in related articles
When the data will become available and for how long
Starting an access period 6 months after publishing results
To whom data/document is available
Only for scientific scholars and academic researchers
Under which criteria data/document could be used
Only in line with the analysis and research related to the original title of this article
From where data/document is obtainable
Contact Mr. Emad Al Kathir through the following email address: EMADalkasir@yahoo.com
What processes are involved for a request to access data/document
The documentation will be sent to the email address at least two months after submitting the request by email.
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