To evaluate the effect of an emotion regulation training intervention on social functioning of patients with psychiatric disorders
Design
intervention and control group, followed immediately after the intervention and three months later, A convenient sample of 60 patients with psychiatric disorder divided randomly into study and control group (30 patients in each). the selection of sample based on the following . only one center (psychiatric inpatient department of Tanta University Hospital. )
Settings and conduct
psychiatric inpatient department of Tanta University Hospital, with a capacity of 31 beds divided into two wards for men (17 beds) and two wards for women (14 beds). respect for all patients, right of autonomy .The intervention don't produce any harm or pain to the patients. fairness must be considered ;all the intervention group receive the same training exercises and numbers of session . The study subjects have the right to withdrawn from this study at any time without any negative impact on services they are currently receiving or will be received in the future.
Participants/Inclusion and exclusion criteria
Inclusion criteria:able to communicate relevantly, and agree to participate in the study
Diagnosis according to DSM-5 criteria
Exclusion criteria: Any evidence of organic brain disease, mental retardation, and or substance use disorder and acute stage of illness.
Intervention groups
The intervention group will divided into subgroups. Each subgroup ranged between 4 to 6 patients. intervention group will receive 10 training sessions (with a series of 12 training exercise) , each session lasting from (60-90) minutes; 3 times per week for a period of 4 weeks.the control will receive the routine care that provided in the hospital .
Main outcome variables
social functioning
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200402046920N1
Registration date:2020-04-09, 1399/01/21
Registration timing:prospective
Last update:2020-04-09, 1399/01/21
Update count:0
Registration date
2020-04-09, 1399/01/21
Registrant information
Name
Souzan Harfush
Name of organization / entity
Tanta university , Faculty of Nursing
Country
Egypt
Phone
+20 40 3331841
Email address
suzan.ahmed@nursing.tanta.edu.eg
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-30, 1399/02/11
Expected recruitment end date
2020-07-30, 1399/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of an Emotion Regulation Training intervention on Social Functioning of Patients with Psychiatric Disorders
Public title
Effect of an Emotion Regulation Training intervention on Social Functioning of Patients with Psychiatric Disorders
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Able to communicate relevantly
Agree to participate in the study
Diagnosis according to DSM-5 criteria for the psychiatric disorders
Exclusion criteria:
Any evidence of organic brain disease, mental retardation, and or substance use disorder
Acute stage of illness.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
• The control and study group will be assigned using simple randomization , by picking their codes up from a pool. The first two-selected codes will be assigned for the control group and the second two for the study group. The process was repeated till the required number obtained.
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 committe of faculty of medicine ,tanta university
Street address
Algeish street ,tanta,Algharibia, Egypt,faculty of medicine
City
Tanta
Postal code
31111
Approval date
2018-08-18, 1397/05/27
Ethics committee reference number
32502/08/18
Health conditions studied
1
Description of health condition studied
emotional disturbance( problems in identification ,understanding,and expression of emotion )
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
social functioning
Timepoint
before intervention ,immediately after intervention, and three months later
Method of measurement
using social functioning scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:• The intervention group divided into subgroups. Each subgroup ranged between 4 to 6 patients. • The emotion regulation training program will conducted through 10 training sessions with a series of 12 training exercise , each lasting from (60-90) minutes; 3 times per week for a period of 4 weeks. Session 1: The first and second exercise intended to help the subjects to recognize emotion • Understanding emotional words: expressing emotion by using emotion word cards (e.g., happy)• Learning emotional words: matching emotional word cards and emotional face cards.Session 2: the third and fourth exercises intended to help the subjects to identify emotion • Finding emotional words: choosing emotional word cards from emotional face cards that represent different emotions.• Identifying emotion by context: choose emotional word cards from a short film cartoon that represent certain emotions.Stage two: Emotion expression training : The aim of this stage was to help the patient to express emotions. This stage comprised four exercises that was conduct into three sessions.Session 3: The fifth and sixth exercise intended to help the subjects to express emotions • Making facial expression: the patients expressed emotions by emotional face cards.• Facial expression relay: Identifying one’s facial expression and passing it to the next person. This procedure was applied on all emotional face cards where each patient in the group will draw different facial expressions Session 4:- the seventh exercise was performed to help the patients to express emotion by using image. • Storytelling and watching a film and expressing emotion: The researcher asked the patients to write or draw their feelings after emotional storytelling and watching a film cartoon. Session 5: -The eighth exercise in this session was to help the patients to express emotion by using sentence. • Expressing emotion using written instructions: Each patient by turn was pick a card with a written instruction of certain emotional expression in a group.Stage three: Emotion application training. The aim of this stage was to help the patient to share their feelings, understand complex emotion and emotional inference. This stage comprised three exercises that conducted into two sessions.Session 6: - the nineth exercise was applied to help the patients to share their feelings:• Emotional mask: making emotional mask by drawing one’s feeling on a mask then wearing each emotional mask and expressing their feelings. Session 7: - the tenth and eleventh exercises were used to help the patients to understand complex emotion and emotion inference:• Making facial expressions by context: expressing feelings using written emotional sentences.• Exercising emotional inference: making up a story with emotional sentence cards.Stage four: Emotional control training. This stage conducted into 2 sessions ; the aim of this stage is to help the patient to develop self -awareness and cope with negative emotions. The researcher used the following learning strategies during the program: modeling, role play/ behavioral rehearsal, getting participant’s feedback (e.g. providing corrective feedback) and positive reinforcement (e.g. praising a client’s efforts).
Category
Treatment - Other
2
Description
Control group: will receive the routine care that provided in the hospital
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
psychiatric inpatient department of Tanta University Hospital
Full name of responsible person
Professor Mai Issa
Street address
Algeish street,Tanta, Algharibia ,Egypt
City
Tanta
Postal code
31111
Phone
+20 40 3336666
Email
maieissa@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tanta university
Full name of responsible person
Professor Magdy Abd elraof saba
Street address
Algeish street,
City
Tanta
Postal code
31111
Phone
+20 40 3317928
Email
tanta_unv@unv.tanta.edu.eg
Web page address
https://tanta.edu.eg
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tanta university
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
Tanta university , Faculty of Nursing
Full name of responsible person
Souzan Harfush
Position
Lecturer of psychiatric nursing
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Elgeish street, Faculty of nursing ,Tanta ,Egypt
City
Tanta
Province
Egypt , Algharbia
Postal code
31111
Phone
+20 40 3331841
Fax
Email
suzan.ahmed@nursing.tanta.edu.eg
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tanta university , Faculty of Nursing
Full name of responsible person
Souzan Harfush
Position
Lecturer of psychiatric nursing
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Elgeish street, Faculty of nursing ,Tanta ,Egypt
City
Tanta
Province
Egypt , Algharbia
Postal code
31111
Phone
+20 40 3331841
Fax
Email
suzan.ahmed@nursing.tanta.edu.eg
Person responsible for updating data
Contact
Name of organization / entity
Tanta university , Faculty of Nursing
Full name of responsible person
Souzan Harfush
Position
Lecturer of psychiatric nursing
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Elgeish street, Faculty of nursing ,Tanta ,Egypt
City
Tanta
Province
Egypt , Algharbia
Postal code
31111
Phone
+20 40 3331841
Fax
Email
suzan.ahmed@nursing.tanta.edu.eg
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no further information
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
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