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Comparing the effectiveness of online group compassion-based therapy and acceptance and commitment therapy on the psychological symptoms of patients with peptic ulcer

Protocol summary

Study aim
Comparing the effectiveness of online group compassion-based therapy and acceptance and commitment therapy on the psychological symptoms of patients with peptic ulcer
Design
A clinical trial with a control group, with parallel groups including two intervention groups and one group without treatment, without blinding, randomized, on 45 patients, random number generator software was used for randomization.
Settings and conduct
The recent clinical trial was conducted at an open-label university medical center using the available sampling method. The study objectives were explained to the participants, who will be screened for inclusion criteria. Those meeting the criteria will be randomly assigned to one of three groups, each comprising 15 people. The first group will receive 6 sessions of acceptance and commitment psychotherapy, the second group will receive 6 sessions of psychotherapy based on self compassion, and the third group will not receive any treatment. Scales will be completed before and after the treatment.
Participants/Inclusion and exclusion criteria
Having peptic ulcer diagnosed by a gastroenterologist, Age between 18 and 60 years, At least having a diploma degree, Ability to use smartphones, Not having neurological disorders.
Intervention groups
Psychotherapy based on compassion and commitment in 6 sessions of 90 minutes in groups and online. Psychotherapy based on self-compassion in 6 sessions of 90 minutes in a group and online. The control group did not receive the intervention.
Main outcome variables
Severity of depressive symptoms, Severity of anxiety symptoms, The amount of quality of life, The amount of stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220316054306N3
Registration date: 2024-08-25, 1403/06/04
Registration timing: registered_while_recruiting

Last update: 2024-08-25, 1403/06/04
Update count: 0
Registration date
2024-08-25, 1403/06/04
Registrant information
Name
Shahab Lotfinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 23871
Email address
lotfiniashahab@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-18, 1403/03/29
Expected recruitment end date
2024-09-19, 1403/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of online group compassion-based therapy and acceptance and commitment therapy on the psychological symptoms of patients with peptic ulcer
Public title
Effectiveness of compassion-based therapy and acceptance and commitment therapy on the psychological symptoms of peptic ulcer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having peptic ulcer diagnosed by a gastroenterologist Age between 18 and 60 years At least having diploma degree Ability to use smartphones
Exclusion criteria:
having neurological disorders
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: 45
Randomization (investigator's opinion)
Randomized
Randomization description
All the people who entered the study were given a code, then these codes were entered into the Randomly assign online software (https://www.graphpad.com/quickcalcs/randomize1.cfm) and the software randomly assigned each code to a 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
Ethic committee of Shahid Beheshti University of Medical Science
Street address
Bldg No.2 Shahid Beheshti University of Medical science, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2024-06-18, 1403/03/29
Ethics committee reference number
IR.SBMU.MSP.REC.1403.159

Health conditions studied

1

Description of health condition studied
Peptic ulcer
ICD-10 code
K27
ICD-10 code description
Peptic ulcer, site unspecified

Primary outcomes

1

Description
Severity of depressive symptoms
Timepoint
Before and after intervention
Method of measurement
Based on the score obtained in Depression Anxiety Stress Scales

2

Description
Severity of anxiety symptoms
Timepoint
Before and after intervention
Method of measurement
Depression Anxiety Stress Scales

3

Description
Severity of stress
Timepoint
Before and after intervention
Method of measurement
Depression Anxiety Stress Scales

4

Description
The amount of quality of life
Timepoint
Before and after intervention
Method of measurement
Based on the score obtained in the World Health Organization Quality of Life Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Psychotherapy sessions based on acceptance and commitment: The sessions will be conducted online and consist of 6 sessions, each lasting 90 minutes. First session: Establishing communication and introducing participants to the intervention topic. Second session: Discussing the temporary and ineffectiveness of methods using metaphors. Third session: Identifying ineffective strategies and accepting painful personal events. Fourth session: Explaining the avoidance of painful experiences and raising awareness about their consequences. Fifth session: Examining the interconnected relationship between behavior, emotions, and cognition. Sixth session: Explaining the concepts of role and context, introducing the concept of values, and creating motivation for change and commitment to action.
Category
Treatment - Other

2

Description
Intervention group: Self-compassion-based psychotherapy group meetings will be conducted online in six 90-minute sessions. The first session will focus on introducing the concept of compassion and its importance in life. In the second session, participants will be taught ways to enhance positive experiences, increase awareness of positive experiences, create positive experiences through mental visualization, and learn about compassionate behaviors. The third session will involve training in identifying negative self-evaluations and their impact on compassion. During the fourth session, participants will receive training on recognizing how and to what extent they practice compassion. The fifth session will focus on cultivating self-compassion through conscious attention. In the final session, participants will receive training on transforming negative self-compassion by engaging in behaviors that counteract those negative feelings.
Category
Treatment - Other

3

Description
Control group: Control group: Waiting list. Patients in this group do not receive any therapy.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Shahab lotfinia
Street address
Ayatollah Taleghani Hospital, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
taleghanihospital@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
‪Dr Afshin Zarghi
Street address
No.2 Shahid Beheshti University of Medical science, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
Intl_office@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
Amir Sam Kianimoghadam
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No.2 Shahid Beheshti University of Medical science, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
kianimoghadam@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahab
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.2 Shahid Beheshti University of Medical science, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
lotfiniashahab@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahab
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.2 Shahid Beheshti University of Medical science, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
lotfiniashahab@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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