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Comparison of efficacy of internet- based cognitive behavior therapy alone versus combination CBT with well-being therapy for improvement of depressive symptoms of pregnant women

Protocol summary

Study aim
Determination of the effect of internet-based cognitive behavior therapy (iCBT) alone vs a combination of iCBT with Well being therapy (WBT) on depressive symptoms of pregnant women
Design
A clinical trial with randomized, four parallel groups on 408 patients. R software version 3,6,1 will be used for randomization
Settings and conduct
In a multicluster randomized clinical trial of equality type, 408 pregnant women with depressive symptoms are divided into four groups of psychotherapy models (iCBT with reminder sessions - iCBT without reminder sessions - iCBT combination with iWBT without reminder sessions - iCBT and iWBT combination therapy with reminder sessions). The content of four types of treatment is prepared online in 8 sessions. The validity of the content will be confirmed by the research team. Reminder groups will receive a reminder dose during pregnancy monthly until the end of pregnancy, and at postpartum every two months until the first year of birth. Outcomes of this study are Edinburgh Depression, Psychiatric Symptoms (BSI-18), Specific Pregnancy Stress (NuPDQ), Psychological well-being, Maternal-Child Postnatal Attachment, Ages and Stages Questionnaire (ASQ).
Participants/Inclusion and exclusion criteria
Inclusion: Gestational age less than 30 weeks, Edinburgh depression score higher than 10 for low-risk pregnancies and higher than 7 for high-risk pregnancies, access to computers and the Internet, Educational level higher than primary school, consent to enter treatment Exclusion: Current substance abuse or dependence, currently using depressant drugs, recently receiving psychotherapy (<6 months), having a severe psychiatric, having suicidal ideations.
Intervention groups
Group 1: Only iCBT Group 2: Combined iCBT with WBT Group 3: iCBT with reminder doses. Group 4: Combined iCBT and iWBT with reminder doses.
Main outcome variables
Symptoms of depression and anxiety

General information

Reason for update
Acronym
ICBT: Internet-based Cognitive behavior therapy IWBT: Internet-base well-being treatment
IRCT registration information
IRCT registration number: IRCT20110228005931N12
Registration date: 2022-06-05, 1401/03/15
Registration timing: prospective

Last update: 2022-06-05, 1401/03/15
Update count: 0
Registration date
2022-06-05, 1401/03/15
Registrant information
Name
Mahbobeh Faramarzi
Name of organization / entity
Babol University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1329 4456
Email address
m.faramarzi@mubabol.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2026-03-21, 1405/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of internet- based cognitive behavior therapy alone versus combination CBT with well-being therapy for improvement of depressive symptoms of pregnant women
Public title
Effect of Internet cognitive-behavioral psychotherapy with psychological well-being on depression of pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age of less than 30 weeks Edinburgh depression score higher than 10 for low-risk pregnancies and higher than 7 for high-risk pregnancies Access to computers and the Internet Educational level higher than primary school Consent to enter treatment
Exclusion criteria:
Current substance abuse or dependence Current use of antidepressant drugs, or recent psychotherapy for depression/anxiety (<4 weeks) Women with severe depression disorders who require medical treatment Severe psychiatric disorders or suicidal ideations Childbirth before the end of the treatment period
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 408
Randomization (investigator's opinion)
Randomized
Randomization description
After checking inclusion and exclusion criteria, participants are allocated randomly into four groups by permuted block randomization method. The block size is 4 and each block of each intervention group will be repeated once. Then, will be generated 102 blocks with 4 sizes and a total of 408 sequences using the statistical program in R software environment version 3,6,1. The participants will be assigned to four groups of the study by a randomly generated list.
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
Ethic Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
47745-47176
Approval date
2021-10-06, 1400/07/14
Ethics committee reference number
IR.MUBABOL.HRI.REC.1400.084

Health conditions studied

1

Description of health condition studied
Depressive Disorder
ICD-10 code
F32.9
ICD-10 code description
Depression NOS

Primary outcomes

1

Description
Depression
Timepoint
Before intervention, immediately after intervention, follow-ups 6 and 12 months after intervention
Method of measurement
Edinburgh Postnatal Depression Inventory

2

Description
Anxiety
Timepoint
Before intervention, immediately after intervention, follow-ups 6 and 12 months after intervention
Method of measurement
Brief Symptoms Inventory (BSI-18)

Secondary outcomes

1

Description
Pregnancy stress
Timepoint
Before the intervention, at end of the intervention, and follow- ups of 1 and 6 months after the end of intervention
Method of measurement
Revised Prenatal Distress Questionnaire (NuPDQ)

2

Description
Mother and child attachment
Timepoint
After the birth of a child at 4 and 12 months
Method of measurement
Mother-child attachment questionnaire

3

Description
Child development
Timepoint
After the birth of a child at 4, and 12 months
Method of measurement
Ages and Stages Questionnaire (ASQ)

4

Description
Psychological well-being
Timepoint
Before the intervention, at end of the intervention, and follow- ups of 1 and 6 months after the end of intervention
Method of measurement
Ryff psychological well-being questionnaire

Intervention groups

1

Description
Intervention group 1: Participants in this group receive online cognitive behavioral therapy in 8 sessions of 90 minutes, once a week.
Category
Treatment - Other

2

Description
Intervention group 2: Participants in this group receive combined online cognitive-behavioral therapy with psychological well-being in 8 sessions of 90 minutes, once a week.
Category
Treatment - Other

3

Description
Intervention group 3: Participants in this group receive Internet cognitive behavioral therapy in 8 sessions of 90 minutes, once a week, with reminder sessions.
Category
Treatment - Other

4

Description
Fourth intervention group: Participants in this group receive combined online cognitive-behavioral therapy with psychological well-being in 8 sessions of 90 minutes, once a week, with reminder sessions.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rouhani and Yahya Nejad Educational and Medical Center and private offices in Babol
Full name of responsible person
D.zahra basirat
Street address
Ayatollah Rouhani Hospital, Ganjafrouz Avenue, Babol, Mazandaran Province, Iran.
City
Babol
Province
Mazandaran
Postal code
4731713119
Phone
+98 911 111 2979
Fax
+98 11 3223 8301
Email
zahra_basirat@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 1219 9592
Email
rezaghadimi@yahoo.com
Grant name
Research Project
Grant code / Reference number
724133475
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 1219 9592
Email
Mahbob330@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Farzan kheirkhah
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 1219 9592
Email
drfarzankh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran City Babol Province Mazandaran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 1219 9592
Email
mahbob330@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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