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The effectiveness of cognitive-behavioral group therapy on improving metacognitive beliefs, insight and adherence of treatment and reducing pressure in caregivers of patients with schizophrenia

Protocol summary

Study aim
Effect of cognitive-behavioral group therapy on improving metacognitive beliefs, insight, adherence therapy and reducing the stress of caring for schizophrenic patients
Design
A clinical trial with a control group, with parallel, non-random groups, on 36 patients. In this way, each new patient is placed in one of the research groups, respectively.
Settings and conduct
The present study will be performed in Shiraz Psychiatric Hospital. In the intervention group, the treatment program will be performed by an therapist in seven sessions. Each session begins with an initial discussion and question and then continues for an hour and a half on the topic of the same discussion session. And at the end of each session, summarized information about the same session is given to patients Will be located.
Participants/Inclusion and exclusion criteria
Inclusion: Having diagnostic criteria for schizophrenia disorde Age between 18 and 50 years Minimum secondary education Not receiving electroconvulsive therapy No entry: Mental retardation Brain Injury Serious thoughts of suicide The onset of the acute phase of the disease
Intervention groups
In the intervention group, the treatment program will be performed by an experienced group therapist in seven sessions (three times a week) based on a treatment protocol adapted from Robert Paul Lieberman's 16-session community return program. In order to investigate the effect of therapist's attention, the placebo group of therapist's attention will watch documentaries without psychological background for seven sessions and will discuss the subject of the film. The control group will also receive only their usual treatments, which include a visit to a psychiatrist
Main outcome variables
Reducing the pressure on caregivers, increasing the level of insight and adherence to treatment of schizophrenic patients, improving the patient's metacognitive beliefs

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210912052449N1
Registration date: 2022-01-11, 1400/10/21
Registration timing: retrospective

Last update: 2022-01-11, 1400/10/21
Update count: 0
Registration date
2022-01-11, 1400/10/21
Registrant information
Name
samad fereidooni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 9834 6905
Email address
psysamadf@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive-behavioral group therapy on improving metacognitive beliefs, insight and adherence of treatment and reducing pressure in caregivers of patients with schizophrenia
Public title
The effectiveness of cognitive-behavioral group therapy on patients with schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having diagnostic criteria for schizophrenia disorder, according to DSM 5 Age range between 18 and 50 years Having at least a middle school degree Not receiving electroconvulsive therapy (at least two months before and during hospitalization) Not receiving psychological treatments at the same time as entering the study or 3 months before entering the study Patient and family consent to participate in the study Living with a family member (at least three months before hospitalization)
Exclusion criteria:
Patients who are in the acute phase of the disease Patients who are active substance abusers Having serious suicidal thoughts Having any serious medical condition (to prevents further treatment) Mental retardation Brain damage More than one group absence session Comorbidity of substance dependence disorder Comorbidity of other psychiatric disorders
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
7134814336
Approval date
2021-12-05, 1400/09/14
Ethics committee reference number
IR.SUMS.REC.1400.673

Health conditions studied

1

Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia

Primary outcomes

1

Description
Metacognitive Beliefs Score in Adrienne Wells Metacognitive Beliefs Questionnaire
Timepoint
Assessment of metacognitive beliefs at the beginning of the study (before the intervention) and after the intervention and three months after the intervention
Method of measurement
Adrienne Wells Metacognitive Beliefs Questionnaire

2

Description
Insight level score based on Insight and Treatment Attitudes Questionnaire
Timepoint
Assessment of the patient's level of insight at the beginning of the study (before the intervention) and after the intervention and three months after the intervention
Method of measurement
Insight and Treatment Attitudes Questionnaire

3

Description
Score of adherence to treatment on the Medication Adherence Rating Scale
Timepoint
Assessment of patient adherence to treatment at the beginning of the study (before the intervention) and after the intervention and three months after the intervention
Method of measurement
Medication Adherence Rating Scale

4

Description
Care pressure level score based on Novak care pressure questionnaire
Timepoint
Assessment of the level of care pressure at the beginning of the study (before the intervention) and after the intervention and three months after the intervention
Method of measurement
Novak Care Pressure Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: In the intervention group, the treatment program will be performed by an experienced group therapist in seven sessions with 15 minutes of rest (three times a week) based on a treatment protocol adapted from Robert Paul Lieberman's 16-session community return program. This program is an "Independent and Social Life Skills" program developed by the Center for Psychiatric Rehabilitation Clinical Research at UCLA. Each session begins with an initial discussion and question and then continues for an hour and a half on the topic of the same discussion session. Topics discussed in each session include the following: Session 1: The nature of mental disorders, stigmatization and normalization, Session 2: Communication and expression skills, Session 3: Symptoms of the disorder and symptoms of recurrence, Session 4: Medication, Benefits and side effects, Session 5: Stress management skills, Session 6: Rehabilitation and self-care skills, Session 7: Preparation for discharge.
Category
Rehabilitation

2

Description
Intervention group 2: In order to evaluate the effect of the therapist's attention, the therapist's placebo group will watch documentaries without a psychological background for seven sessions in the presence of the therapist and will discuss the subject of the film.
Category
Rehabilitation

3

Description
Control group: The control group will also receive only their usual treatments, which include a visit to a psychiatrist.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Psychiatric Hospital
Full name of responsible person
Samad Fereidooni
Street address
Shiraz Psychiatric Hospital, Bajgah
City
Shiraz
Province
Fars
Postal code
7144113331
Phone
+98 71 3260 5701
Fax
+98 71 3627 7502
Email
psysamadf@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Razeghian Jahromi
Street address
Shiraz Psychiatric Hospital, Bajgah
City
Shiraz
Province
Fars
Postal code
7144193355
Phone
+98 71 3260 5678
Fax
+98 71 3627 7502
Email
psysamadf@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
40
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
Shiraz University of Medical Sciences
Full name of responsible person
Samad Fereidooni
Position
Non-faculty PhD
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shiraz Psychiatric Hospital, Bajgah
City
Shiraz
Province
Fars
Postal code
7144193355
Phone
+98 71 3260 5678
Fax
+98 71 3627 7502
Email
psysamadf@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Samad Fereidooni
Position
Non-faculty PhD
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shiraz Psychiatric Hospital, Bajgah
City
Shiraz
Province
Fars
Postal code
7144193355
Phone
+98 71 3260 5678
Email
psysamadf@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Samad Fereidooni
Position
Non-faculty PhD
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shiraz Psychiatric Hospital, Bajgah
City
Shiraz
Province
Fars
Postal code
7144193355
Phone
+98 71 3260 5678
Email
psysamadf@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
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
By identifying individuals, information will only be published in groups
When the data will become available and for how long
6 months after the end of the research
To whom data/document is available
The data will be available only for the Vice Chancellor for Research of Shiraz University of Medical Sciences
Under which criteria data/document could be used
Only treatment planning for study participants
From where data/document is obtainable
Principal Investigator
What processes are involved for a request to access data/document
After the individual application was approved by the Vice Chancellor for Research of Shiraz University of Medical Sciences
Comments
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