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The Effectiveness of Transdiagnostic based Emotional efficacy on the Faulty Cognitive-affective system, Psychological syndrome and Sleep Quality of Nurses with Anxiety Signs

Protocol summary

Study aim
determination effectiveness of Transdiagnostic based Emotional efficacy on the Faulty Cognitive-affective system, Psychological syndrome and Sleep Quality of Nurses with Anxiety Signs
Design
Selection of 140 nurses with inclusion criteria based on purposive sampling, those with an anxiety score above 16 based on Beck Anxiety form were divided into two groups of 25 with quota sampling method,The treatment group will receive eight 90-minute sessions and a two-month follow-up.
Settings and conduct
The nurses in Chamran and Versaul hospitals who have an anxiety score above 16 are divided into intervention and control groups of 25 persons, which the intervention group receives treatment after two months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 25-45 years; Minimum2 years nursing experience; Minimum bachelor's degree; Working in clinical shift nurses; Satisfaction Exclusion criteria: Psychiatric drug use; experiencing stressors ... History of receiving similar intervention; incomplete response to questionnaires; severe mood disorder such as severe depression
Intervention groups
Emotional efficacy-based therapy, is a combination of acceptance and commitment therapy, dialectical behavior therapy, and cognitive behavioral therapy On defective cognitive system (emotional schema, distress tolerance, uncertainty intolerance, experiential avoidance), psychological syndrome (anxiety, stress, depression, health anxiety, nursing stress) and sleep quality of nursesIn this studywith Anxiety Signs.
Main outcome variables
Outcome variables included psychological symptoms (depression, stress anxiety, health anxiety, nursing stress), impaired cognitive emotional system (experience avoidance, distress tolerance, uncertainty intolerance, emotional schemas), sleep quality, emotional efficacy،anxiety.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191014045096N1
Registration date: 2019-11-28, 1398/09/07
Registration timing: prospective

Last update: 2019-11-28, 1398/09/07
Update count: 0
Registration date
2019-11-28, 1398/09/07
Registrant information
Name
Masoumeh Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3272 4277
Email address
mebrahimi1354@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-31, 1398/10/10
Expected recruitment end date
2020-04-29, 1399/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Transdiagnostic based Emotional efficacy on the Faulty Cognitive-affective system, Psychological syndrome and Sleep Quality of Nurses with Anxiety Signs
Public title
Effect of treatment based Emotional efficacy on the Faulty Cognitive-affective system, Psychological syndrome and Sleep Quality of Nurses with Anxiety Signs
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
At least 2 years of nursing experience Minimum bachelor's degree Clinical staff(Nurses with shifts in circulation) Study consent Age 25-45 years
Exclusion criteria:
Psychiatric drug use Experience stressors(Deceased first class relatives, accidental, divorce)And.. History of receiving similar intervention Incomplete response to questionnaires Physical complications such as limb fractures,Chronic diseases affecting behavior such as tuberculosis Affecting mood disorderSuch as thyroid, diabetes Severe mood disorder, such as severe depression, controlled by medication use
Age
From 25 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, among the nurses working in Ferdowsi hospitals, 140 people who meet the inclusion criteria will be selected by purposeful sampling. Then among them, 50 nurses with moderate to severe anxiety (receiving a score above 16 based on Beck's anxiety form) will be enrolled in the available method and will be randomly divided into two groups of 25, using random cards, The experimental group received the intervention (Emotionally Effective Therapy) during eight 90-minute sessions a week for two months and two months post-treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Two-way curve In terms of group breakdown statistics, (participants, researcher, outcome assessor), both participants and researchers or outcome assessors were unaware of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Vice Chancellor for Technology Research, Birjand University of Medical Sciences, Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2019-10-14, 1398/07/22
Ethics committee reference number
IR.BUMS.REC.1398.224

Health conditions studied

1

Description of health condition studied
Anxiety Syndrome, Defective Affective Cognitive System, Anxiety Symptoms
ICD-10 code
F41.8
ICD-10 code description
Other specified anxiety disorders

Primary outcomes

1

Description
Anxiety score above 16 based on Beck Anxiety Inventory
Timepoint
At the beginning of the study before intervention
Method of measurement
Beck Anxiety Inventory

Secondary outcomes

1

Description
Depression, Anxiety, Stress
Timepoint
Before the intervention, after the end of the intervention and two months follow up
Method of measurement
Depression, Anxiety and Stress Questionnaire DASS-21

2

Description
Health anxiety
Timepoint
Before intervention, after intervention and two months follow up
Method of measurement
Health Anxiety Questionnaire

3

Description
Nursing Stress
Timepoint
Before intervention, after intervention (after eight weeks), two-month follow-up
Method of measurement
Nursing Stress Questionnaire

4

Description
sleep quality
Timepoint
Before the intervention, after the end of the intervention (after eight weeks), two months follow-up
Method of measurement
Pittsburgh Sleep Quality Questionnaire

5

Description
Experience Avoiding
Timepoint
Before intervention, after intervention and two months follow up
Method of measurement
Acceptance and Practice Questionnaire

6

Description
Intolerance of uncertainty
Timepoint
Before intervention, after intervention and 2 months follow up
Method of measurement
Uncertainty Intolerance Questionnaire

7

Description
Distress Tolerance
Timepoint
Before intervention, after intervention, two-month follow-up
Method of measurement
Emotional distress tolerance questionnaire

8

Description
Emotional Schemas
Timepoint
Before intervention, after intervention, two-month follow-up
Method of measurement
Emotional Schema Questionnaire

9

Description
Emotional efficiency
Timepoint
Before intervention, after intervention, two-month follow-up
Method of measurement
Emotional Efficacy Questionnaire

Intervention groups

1

Description
The intervention group will receive emotional efficacy-based metacognitive therapy within two months, consisting of eight weekly sessions of a 90-minute session conducted by a doctor of psychology, followed by a follow-up follow-up of 2 months.
Category
Behavior

2

Description
Control group: The control group does not receive any treatment (inadequate) but after a follow-up follow up a training session will be held.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Mohsen Imantbaleh
Street address
Imam Khomeini Street, Shahid Chamran Hospital
City
Ferdows
Province
South Khorasan
Postal code
9771766559
Phone
+98 56 3272 2801
Email
hsp.chamran@bums.ac.ir

2

Recruitment center
Name of recruitment center
Hazrat Rasoul Hospital
Full name of responsible person
Mehdi Ariafar
Street address
Reza Boulevard, Hazrat Rasool Hospital
City
Ferdows
Province
South Khorasan
Postal code
9771998809
Email
Ferdows.rasoul@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tuba Kazemi
Street address
Vice Chancellor for Technology Research, Birjand University of Medical Sciences, Ghaffari Ave. Open in Google Translate
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 21 3239 5000
Email
public_r@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Islamic Azad University
Full name of responsible person
Masoumeh Ebrahimi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Basij Street, Basij 6, No. 22
City
Ferdows
Province
South Khorasan
Postal code
9771874756
Phone
+98 56 3272 4277
Email
Mebrahimi1354@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoumeh Ebrahimi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Basij
City
Ferdows
Province
South Khorasan
Postal code
9771874756
Phone
+98 56 3272 4277
Email
Mebrahimi1354@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoumeh Ebrahimi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Basij Street, Basij 6, No. 22
City
Ferdows
Province
South Khorasan
Postal code
9771874756
Phone
+98 56 3272 4277
Email
Mebrahimi1354@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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