Comparison effectiveness of web-based unified transdiagnostic treatment versus diagnosis-specific internet psychotherapies for improvement of psychological distress in women with threatened abortion
To compare the effect of two types of psychotherapies on the anxiety of women with threatened abortion
Design
A non-inferiority, non-blind clinical trial with two parallel groups of 116 patients. Random assignment is a block method in which a list of random sequences is generated through the site and provided to a person outside the research team for concealment.
Settings and conduct
This study will be conducted on 116 pregnant women with threatened اabortion referring to hospitals affiliated with Babol University of Medical Sciences and Obstetrics private offices. Women under the threat of abortion are randomly divided into two groups. 58 individuals will receive web-based unified transdiagnostic treatment and 58 individuals will receive web-based disorder-specific treatment. All patients will complete the Edinburgh Depression postnatal Edinburgh Scale (EPDS), BSI-18, Yale-Brown Obsession, and Gasnefsky Emotion Regulation Questionnaire before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women with threatened abortion, gestational age 5-12 weeks, Educational level above primary school, access to the internet, having been diagnosed as one of the mental disorders including depression, anxiety, or obsession compulsion. Exclusion criteria: vaginal bleeding except for the threat of abortion like inevitable abortion, pregnancy through assisted reproductive technology, patients without Baseline ultrasound, diagnosis of severe mental disorder at risk of suicide, receiving other psychotherapy, lack of informed consent.
Intervention groups
Intervention group 1: Participants will receive web-based unified transdiagnostic treatment.
Intervention group 2: Participants will receive diagnosis-specific internet psychotherapies.
The duration of the treatment in both groups is 8 internet sessions of 45 minutes.
Main outcome variables
Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110228005931N13
Registration date:2023-04-13, 1402/01/24
Registration timing:registered_while_recruiting
Last update:2023-04-13, 1402/01/24
Update count:0
Registration date
2023-04-13, 1402/01/24
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
Recruitment complete
Funding source
Expected recruitment start date
2023-04-03, 1402/01/14
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effectiveness of web-based unified transdiagnostic treatment versus diagnosis-specific internet psychotherapies for improvement of psychological distress in women with threatened abortion
Public title
Comparing the effectiveness of web-based unified transdiagnostic treatment with specific diagnosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Education above elementary
Vaginal bleeding related to pregnancy between 5 and 12 weeks
Taking progesterone due to the threat of abortion
Internet access
Having diagnostic criteria for disorders, including depression (MDD, depression NOS), anxiety disorders (Panic disorder, Generalized anxiety disorder, Agoraphobia, Specific phobia, Social phobia, and anxiety NOS) and Obsessive-compulsive disorders based on the DSM-5 Clinical Structured Interview
Exclusion criteria:
Patients with vaginal bleeding for reasons other than threatened abortion
Patients who became pregnant through assisted reproductive technology
Patients diagnosed as missed abortion or inevitable miscarriage and ectopic pregnancy on admission
Patients without baseline ultrasound
Severe psychiatric disorders and suicidal ideation
Receiving other psychotherapy at the same time as this study
Lack of informed consent
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:
116
Randomization (investigator's opinion)
Randomized
Randomization description
One hundred sixteen eligible participants will allocate randomly two groups (58 individuals) by permuted block randomization method. Group A (unified transdiagnostic treatment) and group B (diagnosis-specific) including three subgroups of depression, anxiety, and obsession will be received. The size of each block will be considered 12 using the statistical program on (seadenvelope.com). In each block, 6 times group A and 6 times group B (2 repetitions of each disorder) will be considered and produce a total of 116 sequences. In order to comply with the concealment sequence, the random list is given to a hospital staff member outside the research team who sends the codes to the principal investigator.
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
47176-47745
Approval date
2023-01-09, 1401/10/19
Ethics committee reference number
IR.MUBABOL.REC.1401.158
Health conditions studied
1
Description of health condition studied
Depression Disorders
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Anxiety Disorders
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Obsession Compulsive Disorders
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Depression
Timepoint
Before intervention, after intervention (8 weeks after beginning), fallow-up of 3 month after end of intervention
Method of measurement
Edinburgh Postnatal Depression Inventor
Secondary outcomes
1
Description
Anxiety
Timepoint
Before the intervention, after intervention (8 weeks after beginning), fallow-up of 3 months after the end of the intervention
Method of measurement
Brief Symptoms Inventory (BSI-18)
2
Description
Obsession- compulsion
Timepoint
Before the intervention, after intervention (8 weeks after beginning), follow-up of 3 months after the end of the intervention
Method of measurement
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
3
Description
Emotion regulation
Timepoint
Before intervention, after intervention (8 weeks after beginning), fallow-up of 3 month after end of intervention
Method of measurement
Cognitive emotion regulation questionnaire (CERQ)
Intervention groups
1
Description
Intervention group 1: Participants will receive web-based unified transdiagnostic treatment with a duration of 8 weeks, each session 45 minutes. The Unified protocol for transdiagnostic treatment of the emotional disorder(UP) is an emotion-focused cognitive-behavioral intervention that consists of five modules or "core" components based on elements of cognitive behavioral therapy (CBT) with proven effectiveness that address negative emotions and reactivity. It targets the negative aspects of emotions, which include learning to observe emotional experience; cognitive evaluation in creating and maintaining emotional responses, identifying behaviors affected by emotion, awareness of internal and external triggers of emotion, and learning how to prepare a hierarchy of fear and avoidance.
Category
Treatment - Other
2
Description
Intervention group 2: Participants will receive web-based diagnosis-specific internet psychotherapies including Internet-based cognitive behavior therapy for three disorders (depression, anxiety, and obsession-compulsion disorders) with a duration of 8 weeks, each session of 45 minutes. Specific strategies used in the protocols include the specific strategies used in the protocols included specific treatment of obsessions (types of obsessions, change of mind, confrontation and response prevention, hierarchy of anxiety, and prevention of relapse), depression: (identification and cognitive re-evaluation, negative automatic thoughts and basic beliefs, exercises to test negative beliefs, identifying schemas and changing them) and anxiety (identification and cognitive re-evaluation, cognitive errors, effective and ineffective coping strategies, behavior change, relaxation sessions).