Protocol summary

Study aim
Evaluation of the efficacy of group psychoeducation through in_person meeting, on the symptoms and functional recovery of patients with bipolar disorder.
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, phase 2 on 34 patients. NCSS (Number Cruncher statistical system) software and block random method are used to randomize the study
Settings and conduct
34 patients with schizophrenia who referred to Ibn Sina Psychiatric Hospital in Shiraz in 2020-21will be included in the study. These people will then be randomly divided into groups receiving intervention and placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having bipolar disorder type 1or 2; tHave been in the remission phase for at least three months. Exclusion criteria: having concomitant psychiatric illness; Substance use; Intellectual disability; Simultaneous neurological disease
Intervention groups
Intervention group: In this group, face-to-face training sessions are held based on the Barcelona psychological training model (which includes 21 training sessions and the shortened course is 10 sessions). The number of members in each group will be between six and nine. Meetings will be held twice a week for 45-60 minutes at Ibn Sina Educational and Medical Center in Shiraz. Control group: In the control group, ten training sessions with the same structure described for the intervention group (Meetings twice a week for 45-60 minutes) in the field of prevention and public health for individuals.
Main outcome variables
Change in The 36-Item Short Form Survey (SF-36)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190726044339N2
Registration date: 2020-12-12, 1399/09/22
Registration timing: prospective

Last update: 2020-12-12, 1399/09/22
Update count: 0
Registration date
2020-12-12, 1399/09/22
Registrant information
Name
Seyed Hamdollah Mosavat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 4105
Email address
hamdi_88114@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-20, 1399/09/30
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of group psychoeducation through in_person meeting, on the symptoms and functional recovery of patients with bipolar disorder
Public title
Evaluation of the efficacy of group psychoeducation on the symptoms and functional recovery of patients with bipolar disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having bipolar disorder type 1or 2 Have been in the remission phase for at least three months Age range 18-50 years
Exclusion criteria:
Having other psychiatric disorder Substance use Intellectual disability Simultaneous neurological disease
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher will enrolled participants based on convenience sampling method. NCSS software (Number Cruncher Statistical System) and block randomization method will use for randomization the study. In the block randomization method, participants will categorize into 6 blocks (AABB, ABAB, BBAA, BABA, ABBA, BAAB), each block containing 4 participants. In this study, "A" will assign to the drug group and "B" to the placebo group, for example: in the "ABAB" block, the first person entered the drug group, the second person entered the placebo group, the third person entered the drug group, and the fourth person entered the placebo group. Thus, all eligible participants will randomly assigned to one of the study arms according to the randomization list.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who fills out the questionnaire and the person who teaches are two separate people. Therefore, the educator is not blind to the participants, but the person who records the consequences is blind to the study groups. Participants also do not know whether they are part of the intervention group or the control group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Ibn Sina Hospital; Hafez street
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2020-04-06, 1399/01/18
Ethics committee reference number
IR.SUMS.MED.REC.1399.024

Health conditions studied

1

Description of health condition studied
Bipolar disorder, currently in remission
ICD-10 code
F31.7
ICD-10 code description
Bipolar disorder, currently in remission

Primary outcomes

1

Description
Change in The 36-Item Short Form Health Survey (SF-36) score
Timepoint
Six months
Method of measurement
The 36-Item Short Form Health Survey (SF-36)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, face-to-face training sessions are held based on the Barcelona psychological training model (which includes 21 training sessions and the shortened course is 10 sessions). The number of members in each group will be between six and nine. Meetings will be held twice a week for 45-60 minutes at Ibn Sina Educational and Medical Center in Shiraz.
Category
Treatment - Other

2

Description
Control group: In the control group, ten training sessions with the same structure described for the intervention group (Meetings twice a week for 45-60 minutes) in the field of prevention and public health for individuals
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
bn Sina Psychiatric Hospital(Shiraz
Full name of responsible person
Amir Bazrafshan
Street address
Hafez street
City
Shiraz
Province
Fars
Postal code
71466 76549
Phone
+98 71 3228 9604
Email
bazrafshana@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amir Bazrafshan
Street address
Hafez street
City
Shiraz
Province
Fars
Postal code
71466 76549
Phone
+98 71 3228 9604
Email
bazrafshana@sums.ac.ir
Grant name
Vice Chancellor for Research, Shiraz University of Medical Sciences
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Narjes Saburian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sina Hospital, Hafez St.
City
Shiraz
Province
Fars
Postal code
7654971466
Phone
+98 71 3228 9601
Email
hamdi_88114@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Hamdollah Mosavat
Position
Resident
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sina Hospital, Hafez St.
City
Shiraz
Province
Fars
Postal code
7654971466
Phone
+98 917 840 1495
Email
hamdi_88114@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Hamdollah Mosavat
Position
Resident
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sina Hospital, Hafez St.
City
Shiraz
Province
Fars
Postal code
7654971466
Phone
+98 917 840 1495
Email
hamdi_88114@yahoo.com

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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