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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

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

NCT ID

NCT04223115

First Posted

January 7, 2020

Last Updated

April 28, 2023

Sponsor

University of Turku

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

Studies a U.S. FDA-regulated Device Product

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