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A Randomized Controlled Study of Digitalized Cognitive Behavioral Intervention for Antenatal Depression

Primary Purpose

Depression, Antenatal Depression

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Digitalized CBT with phone coaching
Psychoeducation about depression
Sponsored by
University of Turku
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring digital intervention, cognitive behavioral therapy, antenatal depression

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of TurkuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Digitalized CBT intervention with phone coaching

Psychoeducation about depression

Arm Description

Participants receive weekly sessions of internet-based CBT, including telephone coaching

Participants receive psychoeducative material about depression in digitalized form.

Outcomes

Primary Outcome Measures

Change in the Edinburgh Postnatal Depression Scale (EPDS)
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

Change in the General Anxiety Disorder 7-item scale (GAD-7)
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.
Change in the Beck Depression Inventory II (BDI-II)
To assess the change in depressive symptoms BDI-II will be used.
Social Phobia Inventory (SPIN)
To assess the change in Social Phobia SPIN will be used
Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ)
To assess the change in pregnancy related anxiety PRAQ will be used
Perceived Stress Scale (PSS)
To assess the change in perceived stress PSS will be used

Full Information

First Posted
January 7, 2020
Last Updated
April 28, 2023
Sponsor
University of Turku
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1. Study Identification

Unique Protocol Identification Number
NCT04223115
Brief Title
A Randomized Controlled Study of Digitalized Cognitive Behavioral Intervention for Antenatal Depression
Official Title
Randomized Controlled Trial of Digitalized Cognitive Behavioral Therapy With Telephone Coaching for Mothers Suffering From Depression During Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turku

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Antenatal Depression
Keywords
digital intervention, cognitive behavioral therapy, antenatal depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digitalized CBT intervention with phone coaching
Arm Type
Experimental
Arm Description
Participants receive weekly sessions of internet-based CBT, including telephone coaching
Arm Title
Psychoeducation about depression
Arm Type
Active Comparator
Arm Description
Participants receive psychoeducative material about depression in digitalized form.
Intervention Type
Behavioral
Intervention Name(s)
Digitalized CBT with phone coaching
Intervention Description
Digitally delivered CBT intervention with weekly phone coaching
Intervention Type
Other
Intervention Name(s)
Psychoeducation about depression
Intervention Description
Psychoeducational material about depression in a digitalized form
Primary Outcome Measure Information:
Title
Change in the Edinburgh Postnatal Depression Scale (EPDS)
Description
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.
Time Frame
Baseline and 11 weeks after randomization
Secondary Outcome Measure Information:
Title
Change in the General Anxiety Disorder 7-item scale (GAD-7)
Description
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.
Time Frame
Baseline and 11 weeks after randomization
Title
Change in the Beck Depression Inventory II (BDI-II)
Description
To assess the change in depressive symptoms BDI-II will be used.
Time Frame
Baseline and 11 weeks after randomization
Title
Social Phobia Inventory (SPIN)
Description
To assess the change in Social Phobia SPIN will be used
Time Frame
Baseline and 11 weeks after randomization
Title
Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ)
Description
To assess the change in pregnancy related anxiety PRAQ will be used
Time Frame
Baseline and 11 weeks after randomization
Title
Perceived Stress Scale (PSS)
Description
To assess the change in perceived stress PSS will be used
Time Frame
Baseline and 11 weeks after randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mari Berglund
Phone
+358 504427185
Email
mari.berglund@utu.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Bianca Arrhenius
Email
bianca.p.arrhenius@utu.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre Sourander, Professor
Organizational Affiliation
University of Turku, Research Center for Child Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Turku
City
Turku
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mari Berglund
Phone
+358 504427185
Email
mari.berglund@utu.fi

12. IPD Sharing Statement

Plan to Share IPD
No

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A Randomized Controlled Study of Digitalized Cognitive Behavioral Intervention for Antenatal Depression

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