NCT02366429

Brief Summary

Randomized controlled trial evaluating an Internet-delivered Cognitive Behavioral Therapy (ICBT) adapted for pregnant women suffering from antenatal depression. The ICBT-program will be added to treatment as usual (TAU) and compared to TAU only. Participants (n=60) are recruited from all over Sweden (only Swedish citizens can participate) and are assessed and treated on a distance via a secure web platform and telephone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 5, 2016

Status Verified

September 1, 2016

Enrollment Period

1.1 years

First QC Date

February 12, 2015

Last Update Submit

September 2, 2016

Conditions

Antenatal Depression

Outcome Measures

Primary Outcomes (1)

  • Self-rated depression measured by Montgomery Asberg Depression Rating Scale

    Depression measured by Montgomery Asberg Depression Rating Scale (MADRS-S), a 9-item self-rated measure of change in depression severity. It also screens for suicidality.

    Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum

Secondary Outcomes (6)

  • Self-rated antenatal depression Edinburgh Postnatal Depression Scale

    Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum

  • Self-rated function Work and Social Adjustment Scale

    Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum

  • Self-rated Insomnia Insomnia Severity Index

    Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum

  • Self-rated function/quality of life Euroqol

    Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum

  • Self-rated anxiety and worry GAD-7

    Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum

  • +1 more secondary outcomes

Study Arms (2)

ICBT

EXPERIMENTAL

Internet-based CBT for antenatal depression

Behavioral: ICBT for antenatal depression

TAU

ACTIVE COMPARATOR

Treatment as usual provided at antenatal clinics and other health care instances

Other: TAU

Interventions

ICBT for antenatal depressionBEHAVIORAL

Participants receives active therapist support via the internet to go through a 10-week self-help treatment on a secure web platform

ICBT
TAUOTHER

Treatment as usual provided at antenatal clinics and other health care instances

TAU

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant female \> 18 years old at gestational week 11-28
  • verified moderate depression according to SCID-I with or without concomitant anxiety disorder
  • able to understand the Swedish language orally and in written
  • able to use the internet for the ICBT
  • currently in contact with an antenatal clinic to receive regular care

You may not qualify if:

  • known drug or alcohol abuse
  • serious somatic disorder or psychiatric disorder such as psychosis, bipolar disorder, severe personality disorder, autism or mental retardation and severe melancholic or psychotic depression,
  • having started or changed medication with SSRI, SNRI or mood-stabilizers within 3 weeks,
  • according to psychiatric assessment have a high suicide risk will be excluded from the study. These women will be helped to receive necessary psychiatric treatment as usual.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO

Stockholm, Sweden

Location

Related Publications (1)

  • Forsell E, Bendix M, Hollandare F, Szymanska von Schultz B, Nasiell J, Blomdahl-Wetterholm M, Eriksson C, Kvarned S, Lindau van der Linden J, Soderberg E, Jokinen J, Wide K, Kaldo V. Internet delivered cognitive behavior therapy for antenatal depression: A randomised controlled trial. J Affect Disord. 2017 Oct 15;221:56-64. doi: 10.1016/j.jad.2017.06.013. Epub 2017 Jun 13.

    PMID: 28628768DERIVED

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2015

First Posted

February 19, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

September 5, 2016

Record last verified: 2016-09

Locations

SE(1)