Objectives: The effect of Metacognitive therapy (MCT) in positive and negative symptoms, function and quality of life of patients with schizophrenia
Design: Non randomized, non placebo controlled, single center.
Setting and conduct: Consent is collected from each patient participating in the research projec. Diagnosis is confirmed with The Structured Clinical Interview for DSM-IV (SCID). The first phase of the baseline assessment performed by the tools [Insight scale (IS) / Positive and Negative Syndrome Scale (PANSS) / Psychotic Symptom Rating Scales (PSYRATS) / Global Assessment of Functioning (GAF) / Quality of Life Inventory (QOLI) / Peters et aL Delusions Inventory (PDI)]. Post intervension assessment with basic assessment tools and treatment satisfaction questionnaire will be done within two weeks after end of intervention. The initial follow up assessments at 3 months post intervention and secondary follow up 6 months after the intervention will be done. All assessments before and after therapeutic intervention, as well as MCT is performed by a psychiatric assistant.
Participants: Five patients diagnosed with schizophrenia will be selected from Rozbeh hospital outpatient clients.
Inclusion criteria: Age 18 to 45 years; Diagnosis of schizophrenia according to DSM 5; Be educated at least secondary school; Patient have positive signs; Medicinal changed over the past month and in the last two months have Electroconvulsive therapy (ECT); The patient's condition is stable and no acute psychosis.
Exclusion criteria: Borderline intellectual function, mental retardation; Dependence on drugs or alcohol; Neurological disease; Formal thought disorder, Hostility and extreme aggression; In case of worsening of symptoms or need to change medication or dosage
Intervention: The treatment will be done for at least four weeks; two sessions per week (number of sessions is at least 8 and up to 16 sessions). Each session lasting an hour. Meta cognitive therapy is performed individually in the hospital. The treatment plan will be done based on the treatment protocol provided by Professor Stephen Moritz and Professor Todd Woodward.
Main outcome measures: Positive symptoms, negative symptoms, delusions dimensions, quality of life, function, insight into illness.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110330678N1
Registration date:2017-01-15, 1395/10/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-01-15, 1395/10/26
Registrant information
Name
Zahra Bahramy bidoni
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 9151
Email address
bahramy-z@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice Chancellor of Tehran University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of metacognitive therapy in patient with schizophrenia
Public title
The effect of metacognitive therapy in patient with schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18 to 45 years; diagnosis of schizophrenia according to The Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 is approved by the psychiatrist's interview; Be educated at least secondary school (8 years); The patient has positive symptoms (symptoms are moderate to high in the initial tests); no change in medication over the past month and in the last two months has not received ECT; patient's condition is stable and no acute psychosis
Exclusion criteria: Borderline intellectual functioning or mental retardation based on the history and interviews; Drug or alcohol; Severe neurological disease (epilepsy, Parkinson's, dementia, Multiple sclerosis and any movement disorder); Forms of thought disorder, Hostility and extreme aggression; In case of worsening of symptoms or need to change the medication
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences Ethics Committee
Street address
Tehran University of Medical Sciences, Ghods street, Keshavarz Blvd., Tehran
City
tehran
Postal code
Approval date
2015-12-05, 1394/09/14
Ethics committee reference number
IR.TUMS.REC.1394.1337
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Positive symptoms
Timepoint
Before the intervention, after intervention, three months and six months after intervention
Method of measurement
PANSS and PSYRATS scale
2
Description
Negative symptoms
Timepoint
Before the intervention, after intervention, three months and six months after intervention
Method of measurement
PANSS scale
3
Description
Dimensions of delusions and hallucinations
Timepoint
Before the intervention, after intervention, three months and six months after intervention
Method of measurement
PDI questionnaire
4
Description
Insight
Timepoint
Before the intervention, after intervention, three months and six months after intervention
Method of measurement
BIS scale
5
Description
Quality of life
Timepoint
Before the intervention, after intervention, three months and six months after intervention
Method of measurement
QOLI questionnaire
6
Description
Global Functioning
Timepoint
Before the intervention, after intervention, three months and six months after intervention
Method of measurement
Global Assessment of Functioning
Secondary outcomes
1
Description
Satisfaction with treatment
Timepoint
After the intervention, three months and six months after intervention
Method of measurement
Treatment Satisfaction Questionnaire
Intervention groups
1
Description
The treatment will be done for at least four weeks; two sessions per week (number of sessions is at least 8 and up to 16 sessions). Each session lasting an hour. Meta cognitive therapy is performed individually in the hospital. The treatment plan will be done based on the treatment protocol provided by Professor Stephen Moritz and Professor Todd Woodward.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rozbeh hospital
Full name of responsible person
Zahra bahramy bidoni
Street address
Rozbeh hospital, Southern karegar street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Masud Yunesian
Street address
Tehran University of Medical Science, Ghods street, Keshavarz Blvd., Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Zahra Bahramy bidoni
Position
Psychiatric resident
Other areas of specialty/work
Street address
Rozbeh hospital, Southern karegar street, Tehran
City
Tehran
Postal code
Phone
+98 21 5541 9151
Fax
Email
bahramy-z@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Abolfazl mohammadi
Position
PHD of clinical psychology
Other areas of specialty/work
Street address
Rozbeh hospital, Southern karegar street, Tehran
City
Tehran
Postal code
Phone
+98 21 5541 9151
Fax
Email
a-mohammadi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Zahra Bahramy bidoni
Position
Psychiatric resident
Other areas of specialty/work
Street address
Rozbeh hospital, Southern karegar street, Tehran
City
Tehran
Postal code
Phone
+98 21 5541 9151
Fax
Email
bahramy-z@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)