Protocol summary

Study aim
The effectiveness of acceptance and commitment therapy on prolonged grief bereavement disorder
Design
A quasi-experimental study, with a control group, non-random, was conducted on 30 patients, 15 of them were in the control group.
Settings and conduct
After selecting the participants, according to the entry criteria, the pre-test was performed using Gross's emotion regulation questionnaire and Neff's self-compassion and Gillanders' cognitive fusion in both groups. Then, intervention sessions were conducted on the experimental group with a treatment protocol based on acceptance and commitment during eight 75 minute sessions on a weekly basis at the Health Horizon Clinic in Ghaemshahr with the presence of a trained therapist. During this period, there was no intervention on the control group. After the end of the intervention sessions, the post-test was immediately performed on both groups, and in this way, the data needed to investigate the research hypotheses were collected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: receiving a diagnosis of prolonged grief disorder based on the prolonged grief questionnaire of Prigerson et al. (2021) and a clinical interview. Exclusion criteria: having severe accompanying disorders, including personality disorders
Intervention groups
The intervention group includes people with prolonged grief disorder who receive acceptance and commitment therapy. The intervention group includes people with prolonged grief disorder who do not receive acceptance and commitment therapy.
Main outcome variables
In this research, the variables of emotion regulation, cognitive fusion and self-compassion are considered as outcome variables.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240602061981N1
Registration date: 2024-08-05, 1403/05/15
Registration timing: retrospective

Last update: 2024-08-05, 1403/05/15
Update count: 0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
Asghar Noruzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3303 2891
Email address
asg.noruzi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2023-12-10, 1402/09/19
Actual recruitment start date
2023-10-07, 1402/07/15
Actual recruitment end date
2023-12-10, 1402/09/19
Trial completion date
2024-01-30, 1402/11/10
Scientific title
The Effectiveness of Acceptance and Commitment Therapy on Emotion Regulation, Cognitive Fusion and Self-Compassion of People with Prolonged Grief Disorder
Public title
The Effectiveness of Acceptance and Commitment Therapy on Prolonged Grief Disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
This includes receiving a diagnosis of long-term grief disorder based on the long-term grief questionnaire of Prigerson et al. (2021) and a structured clinical interview by the criteria of the revised text of the Diagnostic and Statistical Manual of Mental Disorders; Being between 19 and 50 years old; don't receive medication at the time of diagnosis and during the research period; No history of substance abuse or substance dependence Inefficiency of other psychological interventions
Exclusion criteria:
Having severe co-occurring disorders including major depressive disorder, personality disorders, bipolar disorders. Having some kind of medical condition that makes the person seek immediate treatment Patients with features of psychosis, mania or hypomania, or borderline personality disorders (because these patients have emotional instability and the process of evaluating their mood will be difficult).
Age
From 19 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sari Azad university
Street address
Ghaemshahr- Shanzdeh Metri Street- Marmar Alley - Marvarid Building- 3rd floor
City
sari
Province
Mazandaran
Postal code
4765983551
Approval date
2023-11-14, 1402/08/23
Ethics committee reference number
IR.IAU.SARI.REC.1402.234

Health conditions studied

1

Description of health condition studied
prolonged grief disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)

Primary outcomes

1

Description
prolonged grief disorder
Timepoint
The study variables were measured before the intervention and after the intervention.
Method of measurement
prolonged grief disorder score in the lprolonged griefquestionnaire of Prigerson et al. (2021)

Secondary outcomes

1

Description
Emotion regulation score
Timepoint
The variables of this study were measured before and after the intervention.
Method of measurement
The emotion regulation score in John and Gross's 10 question emotion regulation questionnaire.

2

Description
self-compassion
Timepoint
The variables of this study were measured before and after the intervention.
Method of measurement
the self-compassion score in Self-Compassion Scale-Long Form by Neff et al (2003).

3

Description
cognitive fusion
Timepoint
The variables of this study were measured before and after the intervention.
Method of measurement
the cognitive fusion score in Gillanders' 12 question cognitive fusion questionnaire (2010).

Intervention groups

1

Description
Intervention group: In the intervention group, acceptance and commitment therapy was performed. Acceptance and commitment therapy is one of the treatments of the third wave of behavioral therapy, which was introduced by Steven Hayes and his colleagues in the early 1980s and is known as ACT, and is rooted in a deep philosophy called functional contextualism, which is theoretically based on The theory is a framework of mental relations that explains how the human mind creates suffering and the useless methods of dealing with it, as well as alternative contextual approaches for these areas. This therapy focuses on the six aspects of acceptance, commitment in action, self as context, cognitive fusion, values, and presence in the present moment and seeks to improve psychological flexibility. The number of treatment sessions of this intervention can consist of 6 sessions and affect disorders such as major depressive disorder, anxiety disorders and trauma-related disorders.
Category
Rehabilitation

2

Description
Control group: No treatment protocol was performed in this group. In this group of people suffering from prolonged grief disorder, they completed emotion regulation, self-compassion and cognitive fusion questionnaires in the pre-test and after 8 weeks, they repeated the previous questionnaires again. In these 8 weeks, no intervention has been done on this group.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiassr hospital
Full name of responsible person
khalili
Street address
Sari St. - Qaemshahr Valiasr Hospital
City
Qaemshahr
Province
Mazandaran
Postal code
4761893837
Phone
+98 11 4203 2035
Email
daraeimahdiye@gmail.com

2

Recruitment center
Name of recruitment center
Ofogh salamat clinic
Full name of responsible person
roghaye eslamnia
Street address
Sari St., corner of Almania Alley, Hakim Building, 3rd floor
City
qaemshahr
Province
Mazandaran
Postal code
4765983551
Phone
+98 11 4225 1527
Email
daraeimahdiye@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Asghar noruzi
Street address
Sari-Qaran Street-Qo Medical Complex-Unit 17
City
sari
Province
Mazandaran
Postal code
4765983551
Phone
+98 11 4242 3903
Email
asg.noruzi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
Proportion provided by this source
2
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
mahdiye daraei
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Qaemshahr - Shanzdeh Meter Street - Marmar Alley - Marwarid Building - 3rd floor
City
Qaemshar
Province
Mazandaran
Postal code
4765983551
Phone
+98 11 4225 1527
Email
daraeimahdiye@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
asghar noruzi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Sari-Qaran Street-Qo Medical Complex-Unit 17
City
sari
Province
Mazandaran
Postal code
4765983551
Phone
009891133310585
Email
asg.noruzi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
mahdiye daraei
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Qaemshahr - Shanzdeh Meter Street - Marmar Alley - Marwarid Building - 3rd floor
City
Qaemshahr
Province
Mazandaran
Postal code
4765983551
Phone
+98 11 4225 1527
Email
daraeimahdiye@gmail.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
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Title and more details about the data/document
Questionnaires completed by the control group and the demographic information can be shared and presented.
When the data will become available and for how long
Access can start 6 months after the results are published.
To whom data/document is available
The data is accessible only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
People requesting study data can use the data if they want to use this documentation for future studies to compare with other disorders or other psychological variables or other therapeutic interventions. Also, their studies should have a code of ethics or if they are from an organization, there should be a necessary license.
From where data/document is obtainable
They can through the journal in which this article is published or through email daraeimahdiye@gmai.com to access the data.
What processes are involved for a request to access data/document
After applying through the given email, they should send their proposal and code of ethics as well as their program and wait for a response.
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