1. Home
  2. Approved trials
  3. » فارسی

Comparison Effectiveness of Treatment Based on Acceptance and Commitment, Compassion-Based Therapy and Combination Therapy on Depression, Anxiety, Chronic Pain, Quality of Life, Ineffective Attitudes, Compliance Therapy and Clinical Syndrome in Patients with Systemic Lupus

Protocol summary

Study aim
Comparison of the effectiveness of group therapy based on acceptance and commitment, compassion and combination on depression, anxiety (clinical symptoms), chronic pain, quality of life, dysfunctional attitudes and follow-up treatment of patients with systemic lupus
Design
Clinical trials with control groups, with parallel groups, are not blind, randomized, and have been performed on 100 patients.
Settings and conduct
Samples used by people referred to Hafez Hospital in Shiraz and Dr. Aflaki's Rheumatology Clinic. In order to conduct training and psychological interventions, it was done using the sessions of the investigator's counseling and psychotherapy clinic. The present research method was quasi-experimental and its design was pre-experimental-post-experimental and quarterly follow-up with the control group. After determining the research sample, by examining the general characteristics of the subjects, according to the stratified sampling method, four groups of 20 people were separated from the study population.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range 25 to 40 years old; at least 6 months and a maximum of 2 years from the time of diagnosis; not having another physical illness other than lupus; not taking psychiatric drugs; the motivation to participate in the program during the initial interview; no participation in other psychological courses at the same time.
Intervention groups
Research groups have learned the third wave of psychological therapies, including acceptance-based therapy and commitment and compassion-based therapy, to reduce the psychological effects of depression, anxiety, chronic pain, dysfunctional attitudes, and their adherence to specific therapies.
Main outcome variables
Depression; anxiety; chronic pain; quality of life; dysfunctional attitudes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200215046500N1
Registration date: 2020-05-05, 1399/02/16
Registration timing: retrospective

Last update: 2020-05-05, 1399/02/16
Update count: 0
Registration date
2020-05-05, 1399/02/16
Registrant information
Name
Ali Mohammad Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3272 5447
Email address
ramin3677s@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2020-03-19, 1398/12/29
Trial completion date
2020-03-19, 1398/12/29
Scientific title
Comparison Effectiveness of Treatment Based on Acceptance and Commitment, Compassion-Based Therapy and Combination Therapy on Depression, Anxiety, Chronic Pain, Quality of Life, Ineffective Attitudes, Compliance Therapy and Clinical Syndrome in Patients with Systemic Lupus
Public title
Comparison Effectiveness of Treatment Based on Acceptance and Commitment, Compassion-Based Therapy and Combination Therapy on Depression, Anxiety
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
At least 6 months and a maximum of 2 years have elapsed since the diagnosis Lack of physical illness other than lupus Do not use psychiatric medications Having the motivation to participate in the program during the initial interview Lack of simultaneous participation in other psychological courses
Exclusion criteria:
Absence of more than two sessions There are physical problems that prevent the patient from attending treatment sessions
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 750
Actual sample size reached: 80
Randomization (investigator's opinion)
Not 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
Islamic Azad university-shahrekord Branch
Street address
Unit 3-Second Floor -- Mani Building - facing Karim Khani Citadel -- Jomhouri Boulevard-Shiraz
City
Shiraz
Province
Fars
Postal code
7144914118
Approval date
2020-02-05, 1398/11/16
Ethics committee reference number
IR.IAU.SHK.REC.1399.002

Health conditions studied

1

Description of health condition studied
Systemic lupus
ICD-10 code
M32.0
ICD-10 code description
Drug-induced systemic lupus erythematosus

Primary outcomes

1

Description
The percentage of people with a Beck questionnaire score above 15.
Timepoint
Measurement period before the start of the intervention and three months after the start of treatment
Method of measurement
Beck Depression Questionnaire

2

Description
The percentage of people with a Zong anxiety score above 44.
Timepoint
Measurement period before the start of the intervention and three months after the start of treatment
Method of measurement
Zong Anxiety Questionnaire

3

Description
The percentage of people with chronic pain scores above 30.
Timepoint
Measurement period before the start of the intervention and three months after the start of treatment
Method of measurement
Revised Chronic Pain Questionnaire

4

Description
The percentage of people whose quality of life score is below 15.
Timepoint
Measurement period before the start of the intervention and three months after the start of treatment
Method of measurement
World Health Organization Quality of Life Questionnaire

5

Description
The percentage of people whose scores of dysfunction are higher than 54.
Timepoint
Measurement period before the start of the intervention and three months after the start of treatment
Method of measurement
Weizmann & Beck's Ineffective Attitudes Questionnaire

6

Description
The percentage of people whose treatment adherence score is less than 25.
Timepoint
Measurement period before the start of the intervention and three months after the start of treatment
Method of measurement
Treatment Follow-up Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: in 12 sessions of group therapy based on two treatment approaches, compassion-based therapy and treatment based on acceptance and commitment on a weekly basis, two 90-minute sessions (treatment based on acceptance and commitment) and 120 minutes (treatment-based therapy). They performed at the Counseling and Psychotherapy Center. In the group meetings, after motivating the treatment and the sense of trust between the members of the group, the rules and techniques of treatment methods were taught.
Category
Treatment - Other

2

Description
Second intervention group: The experimental treatment group participated in 16 90-minute combination therapy sessions twice a week in the secret counseling center. The members of the group also learned verbal aikido skills after motivating them.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez Hospital in Shiraz
Full name of responsible person
Dr. Elham Aflaki
Street address
Chamran Boulevard-Hafez Hospital
City
Shiraz
Province
Fars
Postal code
3478671946
Phone
+98 71 3647 9592
Email
ramin3677s@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Raaz Counseling Center
Full name of responsible person
Mehrnaz Mazarei
Street address
Unit 3-Second Floor, Mani Building, facing Karim Khani Citadel, Jomhouri Boulevard
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3230 5410
Email
amr1034352@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mehrnaz Mazarei
Proportion provided by this source
50
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Arsanjan Azad University
Full name of responsible person
Ali Mohammad Rezaie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Unit 3-Second Floor -- Mani Building - facing Karim Khani Citadel -- Jomhouri Boulevard-Shiraz
City
shiraz
Province
Fars
Postal code
7144914118
Phone
+98 71 3228 6128
Email
ramin3677s@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Raaz Counseling and Psychotherapy Center
Full name of responsible person
Alimohammad Rezaie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Unit 3-Second Floor -- Mani Building - facing Karim Khani Citadel -- Jomhouri Boulevard-Shiraz
City
Shiraz
Province
Fars
Postal code
7144914118
Phone
+98 71 3231 9565
Email
ramin3677s@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Raz Counseling and Psychotherapy Center
Full name of responsible person
Alimohammad Rezaie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Unit 3-Second Floor -- Mani Building - facing Karim Khani Citadel -- Jomhouri Boulevard-Shiraz
City
shiraz
Province
Fars
Postal code
7144914118
Phone
+98 71 3228 6128
Email
ramin3677s@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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only a part of the data, such as information about the main consequence or the like, can be shared.
When the data will become available and for how long
Start of access period from 1399
To whom data/document is available
Data will only be available to researchers working at academic and scientific institutions
Under which criteria data/document could be used
Only general data for guidance
From where data/document is obtainable
I am Dr. Ali Mohammad Rezaei-Secret Counseling Center-Shiraz, Ordibehesht St., Nab Coffee Building 09178843677
What processes are involved for a request to access data/document
The applicant must send his / her request to my e-mail with a complete explanation of why and what to do RAMIN3677S@YAHOO.COM
Comments
Loading...