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Trial record 1 of 2 for:    Antenatal Depression | Finland
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A Randomized Controlled Study of Digitalized Cognitive Behavioral Intervention for Antenatal Depression

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ClinicalTrials.gov Identifier: NCT04223115
Recruitment Status : Recruiting
First Posted : January 10, 2020
Last Update Posted : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
Andre Sourander, University of Turku

Brief Summary:
The main objective of the current research project is to evaluate the effectiveness of the digitalized cognitive behavioral therapy program including telephone coaching for antenatal depressive symptoms. The participants are screened from the general population of pregnant women, as a part of the routine maternity health care check-ups. Mothers with depressive symptoms will be randomized into intervention group receiving guided digitalized treatment program or control group receiving education material about depression in digital form.

Condition or disease Intervention/treatment Phase
Depression Antenatal Depression Behavioral: Digitalized CBT with phone coaching Other: Psychoeducation about depression Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Digitalized Cognitive Behavioral Therapy With Telephone Coaching for Mothers Suffering From Depression During Pregnancy
Actual Study Start Date : June 10, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Digitalized CBT intervention with phone coaching
Participants receive weekly sessions of internet-based CBT, including telephone coaching
Behavioral: Digitalized CBT with phone coaching
Digitally delivered CBT intervention with weekly phone coaching

Active Comparator: Psychoeducation about depression
Participants receive psychoeducative material about depression in digitalized form.
Other: Psychoeducation about depression
Psychoeducational material about depression in a digitalized form




Primary Outcome Measures :
  1. Change in the Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: Baseline and 11 weeks after randomization ]
    EPDS is a ten-item self-report questionnaire originally developed to screen for postpartum depression. The respondents are asked about the symptoms of depression. The total score ranges from 0 to 30.


Secondary Outcome Measures :
  1. Change in the General Anxiety Disorder 7-item scale (GAD-7) [ Time Frame: Baseline and 11 weeks after randomization ]
    To assess the change in anxiety symptoms from baseline to follow-up, we will use the Generalized Anxiety Disorder 7-item Scale (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006), which is a brief screening measure including seven items asking about anxiety symptoms experienced in the previous two weeks.

  2. Change in the Beck Depression Inventory II (BDI-II) [ Time Frame: Baseline and 11 weeks after randomization ]
    To assess the change in depressive symptoms BDI-II will be used.

  3. Social Phobia Inventory (SPIN) [ Time Frame: Baseline and 11 weeks after randomization ]
    To assess the change in Social Phobia SPIN will be used

  4. Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ) [ Time Frame: Baseline and 11 weeks after randomization ]
    To assess the change in pregnancy related anxiety PRAQ will be used

  5. Perceived Stress Scale (PSS) [ Time Frame: Baseline and 11 weeks after randomization ]
    To assess the change in perceived stress PSS will be used



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • fluent in written and spoken Finnish or Swedish
  • access to computer or mobile phone with internet
  • between 12 and 22 weeks pregnant
  • screening and baseline score on the EPDS ≥10 points

Exclusion Criteria:

  • lifetime history of psychotic disorder (e.g. schizophrenia, schizoaffective disorder, bipolar disorder, psychotic depression)
  • active suicidal ideation
  • severe substance abuse or dependence
  • actively ongoing psychotherapy
  • participates in another intervention study aiming at treating the symptoms of antenatal depression
  • multiple pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04223115


Contacts
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Contact: Miika Vuori, PhD +358 50 472 8192 miika.vuori@utu.fi

Locations
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Finland
University of Turku Recruiting
Turku, Finland
Contact: Miika Vuori, PhD    +358 50 472 8192    miika.vuori@utu.fi   
Sponsors and Collaborators
University of Turku
Investigators
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Principal Investigator: Andre Sourander, Professor University of Turku, Research Center for Child Psychiatry
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Responsible Party: Andre Sourander, Professor, Child Psychiatry, University of Turku
ClinicalTrials.gov Identifier: NCT04223115    
Other Study ID Numbers: DEPMOM-2020
First Posted: January 10, 2020    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andre Sourander, University of Turku:
digital intervention
cognitive behavioral therapy
antenatal depression
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders