Antenatal DepressionNCT02366429
ICBT for Antenatal Depression
A study testing ICBT for antenatal depression and TAU in people with Antenatal Depression, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Antenatal Depression
- What is being tested?
- ICBT for antenatal depression and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO
Stockholm
About this study
Official title: Psychological Treatment Via the Internet for Antenatal Depression
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.
Read the detailed description
In order to evaluate feasibility and effectiveness of an ICBT-program for antenatal depression that will be used in a larger clinical trial, the current RCT (n=60) will be performed and act as a pilot for the main study.
Participants will all be receiving the regular treatment (TAU) provided at their antenatal clinic and other health care instances. Half of them will be randomized to an add-on of a previously established 10-week long ICBT-program for depression in general, now adapted for pregnant women. The other half will receive TAU during 10 weeks and then freely decide if they want to participate in the pregnancy-adapted ICBT-program (only possible if 10 or more weeks left till estimated delivery date), start the regular ICBT-program for depression within 2-6 weeks post-partum, or decline ICBT-treatment. The participants in this study will be recruited from all over Sweden via internet, advertisements and information at antenatal clinics. A web-based screening questionnaire will form the basis for a first assessment and review of inclusion criteria, followed by a structured telephone interview where diagnoses (SCID-1 for depression, adjusted for DSM 5, and M.I.N.I. for other diagnoses and assessment of suicide risk) and suitability will be assessed, a CGI-rating will be performed, and the final decision on inclusion will be made.
Level of depression pre- and post-treatment will be assessed with MADRS-S filled out via the internet-treatment platform together with the other self-rating measures used in the main study. A questionnaire where the participants evaluate the content of the adapted ICBT-program and their own use and perceived benefit of the treatment methods will also be given at post-treatment and during treatment.
Structured telephone interview will be held at post-treatment, primarily to assess the content of TAU, to administer CGI and a standardized version for MADRS-S (designed to replace missing questionnaire data), and to make a qualitative evaluation of the participants view of the adapted ICBT-program.
The estimated effect of ICBT compared to TAU is 0.8 (Cohen's d) and with 60 participants and some attrition this will result in a statistical power of 80% for this initial, smaller RCT.
- Conditions
- Antenatal Depression
- Being tested
- ICBT for antenatal depression, TAU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICBT for antenatal depressionBehavioural
Participants receives active therapist support via the internet to go through a 10-week self-help treatment on a secure web platform
TAUOther
Treatment as usual provided at antenatal clinics and other health care instances
| Study group | Role | What they receive |
|---|---|---|
| ICBT | Experimental | Internet-based CBT for antenatal depression Receives: Behavioral: ICBT for antenatal depression |
| TAU | Active comparator | Treatment as usual provided at antenatal clinics and other health care instances Receives: Other: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Edinburgh Postnatal Depression Scale (EPDS; Cox, Holden \& Sagovsky, 1987)
Measured: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Self-rated function Work and Social Adjustment Scale
Work and Social Adjustment Scale (WSAS; Zahra et al., 2014)
Measured: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Self-rated Insomnia Insomnia Severity Index
Insomnia Severity Index (ISI; Bastien, Vallieres \& Morin, 2001)
Measured: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Self-rated function/quality of life Euroqol
Euroqol (EQ-5D ; Hinz et al., 2006),
Measured: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Self-rated anxiety and worry GAD-7
GAD-7(Beard, \& Björgvinsson, 2014)
Measured: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Expert rating of overall disease burden Clinical Global Impression - Severity scale
Clinical Global Impression - Severity scale (CGI-S; Guy, 2000)
Measured: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antenatal DepressionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viktor Kaldo, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366429
- Sponsor's protocol ID
- 20141959311
- Status last verified
- Sep 2016
- First submitted
- 12 Feb 2015
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28628768
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Treatment Via the Internet for Antenatal Depression
- ClinicalTrials.gov ID
- NCT02366429
- Acronym / sponsor ID
- 20141959311
- Conditions
- Antenatal Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In order to evaluate feasibility and effectiveness of an ICBT-program for antenatal depression that will be used in a larger clinical trial, the current RCT (n=60) will be performed and act as a pilot for the main study.
Participants will all be receiving the regular treatment (TAU) provided at their antenatal clinic and other health care instances. Half of them will be randomized to an add-on of a previously established 10-week long ICBT-program for depression in general, now adapted for pregnant women. The other half will receive TAU during 10 weeks and then freely decide if they want to participate in the pregnancy-adapted ICBT-program (only possible if 10 or more weeks left till estimated delivery date), start the regular ICBT-program for depression within 2-6 weeks post-partum, or decline ICBT-treatment. The participants in this study will be recruited from all over Sweden via internet, advertisements and information at antenatal clinics. A web-based screening questionnaire will form the basis for a first assessment and review of inclusion criteria, followed by a structured telephone interview where diagnoses (SCID-1 for depression, adjusted for DSM 5, and M.I.N.I. for other diagnoses and assessment of suicide risk) and suitability will be assessed, a CGI-rating will be performed, and the final decision on inclusion will be made.
Level of depression pre- and post-treatment will be assessed with MADRS-S filled out via the internet-treatment platform together with the other self-rating measures used in the main study. A questionnaire where the participants evaluate the content of the adapted ICBT-program and their own use and perceived benefit of the treatment methods will also be given at post-treatment and during treatment.
Structured telephone interview will be held at post-treatment, primarily to assess the content of TAU, to administer CGI and a standardized version for MADRS-S (designed to replace missing questionnaire data), and to make a qualitative evaluation of the participants view of the adapted ICBT-program.
The estimated effect of ICBT compared to TAU is 0.8 (Cohen's d) and with 60 participants and some attrition this will result in a statistical power of 80% for this initial, smaller RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICBT | Experimental | Behavioral: ICBT for antenatal depressionInternet-based CBT for antenatal depression |
| TAU | Active comparator | Other: TAUTreatment as usual provided at antenatal clinics and other health care instances |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICBT for antenatal depressionParticipants receives active therapist support via the internet to go through a 10-week self-help treatment on a secure web platform | Behavioural | ICBT |
| TAUTreatment as usual provided at antenatal clinics and other health care instances | Other | TAU |
Primary outcome
Self-rated depression measured by Montgomery Asberg Depression Rating Scale
Time frame: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
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.
6 secondary outcomes
Self-rated antenatal depression Edinburgh Postnatal Depression Scale
Time frame: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Self-rated function Work and Social Adjustment Scale
Time frame: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Self-rated Insomnia Insomnia Severity Index
Time frame: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Self-rated function/quality of life Euroqol
Time frame: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Self-rated anxiety and worry GAD-7
Time frame: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Expert rating of overall disease burden Clinical Global Impression - Severity scale
Time frame: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
- Derived from this study: PubMed 28628768Forsell 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.
- Related InfoLink provided by the sponsor.
Related trials for Antenatal Depression
Not yet recruiting
Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
Inflammation, Depression Disorder
Not yet recruiting
Healthy Adaptation to Pregnancy, Postpartum and Parenthood
Perinatal Mental Health, Gestational Weight Gain
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Not yet recruiting
Single Session Personalized Aperiodic Transcranial Alternating Current Stimulation (PandA-tACS) for Antenatal Depression
Antenatal Depression
Not yet recruiting
Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression
Depression During Pregnancy, Postpartum Depression (PPD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICBT for antenatal depression and TAU in people with Antenatal Depression, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-rated depression measured by Montgomery Asberg Depression Rating Scale (time frame: Change from baseline to post-treatment (after 10 weeks) and to 3-4 weeks post-partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02366429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2016.