Determining the effect of well-being therapy on depression, anxiety, self-management in women with type 2 diabetes
Design
A Randomized, Controlled, Double-Blind, Parallel-Group Clinical Trial
Settings and conduct
Therapy is provided at Mashhad Diabetes Center. Samples are selected according to the inclusion criteria and are divided into control and intervention groups. Depression, anxiety and self-management inventory are completed as pretest. The inventories are completed again after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: gender: female; age limit: minimum 35 and maximum 65 years old; scores of higher than 19 on the Beck Depression Inventory (BDI); scores of higher than 16 on the Beck Anxiety Inventory (BAI). Exclusion criteria: exhibiting signs and symptoms of severe mental disorders including personality disorder; receiving other psychological and pharmacological treatments at the time of the research; taking psychiatric medications.
Intervention groups
Intervention group: the well-being therapy program for diabetic patients is composed of 12 sessions of 90 minutes held once a week for three months. Early sessions (1-2): preparing the group, building relationships, and introducing the logic of treatment. Middle session (2-6): identifying existing barriers and removing irrelevant beliefs with the aim of self-observation of care seekers to achieve psychological well-being Last sessions (6-12): introducing multi dimensions of cognitive behavioral model.
Main outcome variables
Self Management; depression; anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191115045451N1
Registration date:2019-12-17, 1398/09/26
Registration timing:retrospective
Last update:2019-12-17, 1398/09/26
Update count:0
Registration date
2019-12-17, 1398/09/26
Registrant information
Name
amin zafaralahyari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3890 6149
Email address
a.zafaralahyari@iautj.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-19, 1398/07/27
Expected recruitment end date
2019-11-19, 1398/08/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cognitive-Behavioral Intervention on Depression, Anxiety and Self-Management in Patients with Diabetes
Public title
The effect of cognitive-behavioral therapy on diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gender: female
Age: Minimum 35 and maximum 65 years old
Depression score of higher than 19 in the 21-item Beck Depression Inventory (BDI-21)
Anxiety score of higher than 16 in the 21-item Beck Anxiety Inventory (BAI-21)
Minimum level of Education: high school diploma
Exclusion criteria:
Evidence of severe mental disorder (including personality disorder),
Other simultaneous psychological and medicinal treatments
Psychiatric medications.
Age
From 35 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blocking is used to make balance amongst the samples of each group under examination. This feature might be useful when meso-level analysis is needed during sampling process, so that each group is callocatedthe same amount of samples. In this design randomizing shall take place based on permuted blocking. Thus, paitients will be grouped in 15 blocks, each comprisingtwopeople from the experimental group and two people from the control group.Finally, group 1 will be treated using cognitive behavioral therapy (CBT) and the control group shall receive notreatment.
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
National Committee on Ethics in Biomedical Research
Street address
Boulevard َamouzegar 17
City
Mashhad
Province
Razavi Khorasan
Postal code
9189895163
Approval date
2019-08-13, 1398/05/22
Ethics committee reference number
IR.IAU.MSHD.REC.1398.083
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Diabetes
Primary outcomes
1
Description
Depression
Timepoint
At the beginning of the study, both experimental and control groups will be measured before and after the intervention.
Method of measurement
Beck Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The cbt program for diabetic patients is composed of 12 sessions of 90 minutes held once a week for three months.Early sessions (1-2): Preparing the group, building relationships, and introducing the logic of treatment. Clinical interview, getting identification data, information about feelings, current distress, previous distress, defining the curriculum process, defining the structure and conditions of cbt, including the number of sessions, duration of sessions, interval between sessionsMiddle session (2-6): Identifying existing barriers and removing irrelevant beliefs with the aim of self-observation of care seekers to achieve psychological cbt the role of lack of positive emotions, giving the first home workout, explaining the concept of optimal experiences, describing thoughts and behaviors that are detrimental to cbt, explaining the concept of self-therapy, explaining problem solving, self-acceptance and its role in mental relaxation Last sessions (6-12):Introduction and explanation of cognitive errors and Modifying maladaptive behavior patterns, Teaching the implementation of behavioral activation technique Anger management training and anti-anxiety management strategy.
Category
N/A
2
Description
Control group:This group receives routine caring actions like glycemic control, medical advice, and prescription of medication from the physician of Diabetes Center. However, it does not receive cbt therapy intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Diabetes Center
Full name of responsible person
Dr. Reza Mohamadi
Street address
9th Vakilabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9189895163
Phone
+98 51 3604 0083
Fax
+98 51 3604 0083
Email
ramin.arminn@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr, Hamid Shahabi
Street address
No. 2, Behvarz 9, Dr. Hesabi 4, Jam Junc., Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
9576174814
Phone
+98 51 5251 0222
Fax
+98 51 3890 6149
Email
ramin.arminn@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
Public or private sector
Private
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
Amin Zafaralahyari
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 2, Behvarz 9, Dr. Hesabi 4, Jam Junc., Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9189895163
Phone
+98 51 3890 6149
Fax
+98 51 3890 6149
Email
ramin.arminn@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Hossein Biyazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 2, Behvarz 9, Dr. Hesabi 4, Jam Junc., Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
9189895163
Phone
+98 51 3890 6149
Fax
+98 51 3890 6149
Email
ramin.arminn@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amin Zafaralahyari
Position
University Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 2, Behvarz 9, Dr. Hesabi 4, Jam Junc., Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
9189895163
Phone
+98 51 3890 6149
Fax
+98 51 3890 6149
Email
ramin.arminn@gmail.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
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