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

Sponsor
University of Turku (Other)
Overall Status
Recruiting
CT.gov ID
NCT04223115
Collaborator
(none)
800
1
2
23.7
33.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Digitalized CBT with phone coaching
  • Other: Psychoeducation about depression
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 10, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in the Edinburgh Postnatal Depression Scale (EPDS) [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) [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) [Baseline and 11 weeks after randomization]

    To assess the change in depressive symptoms BDI-II will be used.

  3. Social Phobia Inventory (SPIN) [Baseline and 11 weeks after randomization]

    To assess the change in Social Phobia SPIN will be used

  4. Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ) [Baseline and 11 weeks after randomization]

    To assess the change in pregnancy related anxiety PRAQ will be used

  5. Perceived Stress Scale (PSS) [Baseline and 11 weeks after randomization]

    To assess the change in perceived stress PSS will be used

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Turku Turku Finland

Sponsors and Collaborators

  • University of Turku

Investigators

  • Principal Investigator: Andre Sourander, Professor, University of Turku, Research Center for Child Psychiatry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andre Sourander, Professor, Child Psychiatry, University of Turku
ClinicalTrials.gov Identifier:
NCT04223115
Other Study ID Numbers:
  • DEPMOM-2020
First Posted:
Jan 10, 2020
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Andre Sourander, Professor, Child Psychiatry, University of Turku
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2021