Antenatal DepressionNCT05533138
Internet CBT for Antenatal Depression
A study testing Therapist Guided Internet-CBT for antenatal depression, Therapist Guided Internet-CBT for antenatal depression and perinatal extra support. and Diagnostic assessment by telephone, video or face-to face - Allocation by chance in people with Antenatal Depression, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Pregnant women in pregnancy week 8-29 screening positive for antenatal depression will be randomized to either choose or to be allotted by chance to different forms of diagnostic assessment; i.e. telephone, video or face-to-face assessment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Antenatal Depression
- What is being tested?
- Therapist Guided Internet-CBT for antenatal depression, Therapist Guided Internet-CBT for antenatal depression and perinatal extra support. and Diagnostic assessment by telephone, video or face-to face - Allocation by chance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 1 siteSweden
- Study dates
- 25 Feb 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate major depression
- Pregnant at treatment start
- Regular contact with maternity mental health clinic
- > 18 years old
- Being able to start the treatment earliest in gestational week 8 and latest in gestational week 30
- Stable medication for depression and/or other psychiatric conditions for at least 3 weeks.
- Being able to participate in the treatment during the treatment time and having access to and being able to use the internet and mobile phone during the treatment time
- Being able to understand the Swedish language orally and in writing
Who cannot join
- Montgomery-Åsberg Depression Rating Scale-Self report version (MADRS-S) score below 15 (symptoms of depression to low) or above 35 (severe depression)
- High risk of self harm or suicide (based on semi-structured clinical suicide risk assessment)
- Psychiatric comorbidity, disability, somatic disorder, or pregnancy complications that prevent treatment participation or that can be negatively affected or compose a risk for the fetus by treatment participation
- Ongoing psychological treatment with similar content
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Psychiatry Southwest, Department of CL Psychiatry & Internetpsychiatry
Stockholm, 141 86
Marie Bendix, PhD, +46 73 637 0864, marie.bendix@ki.se
About this study
Official title: Guided-internet Cognitive Behavioral Therapy for Antenatal Depression - Treatment Effects, Assessment Modalities and Extra Support.
Pregnant women in pregnancy week 8-29 screening positive for antenatal depression will be randomized to either choose or to be allotted by chance to different forms of diagnostic assessment; i.e. telephone, video or face-to-face assessment.
Those diagnosed with mild to moderate major depression will then be randomized to treatment with therapist-guided Internet-delivered Cognitive Behavioral Therapy (ICBT) adapted for women suffering from antenatal depression or to the same treatment with addition of up to three contacts with extra support by a midwife or experienced perinatal mental health nurse.
The primary aim is to assess whether extrasupport in addition to internet-guided pregnancy adapted ICBT decreases depressive symptoms more than internet-guided pregnancy adapted ICBT only. Secondary aims include effects of extrasupport and assessment mode on treatment satisfaction, fidelity and credibility.
- Conditions
- Antenatal Depression
- Being tested
- Therapist Guided Internet-CBT for antenatal depression, Therapist Guided Internet-CBT for antenatal depression and perinatal extra support., Diagnostic assessment by telephone, video or face-to face - Allocation by chance, Diagnostic assessment by telephone, video or face-to face - Allocation by choice
- Keywords
- Cognitive behavior therapy, Internet treatment, Self-help treatment, Perinatal support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist Guided Internet-CBT for antenatal depressionBehavioural
A 10 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression adapted for antenatal depression.
Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.Behavioural
A 10 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression adapted for antenatal depression. Additionally, up to three supportive contacts with a midwife or perinatal mental health nurse to support ICBT treatment and adress general pregnancy related health problems.
Diagnostic assessment by telephone, video or face-to face - Allocation by chanceBehavioural
Structured diagnostic perinatal psychiatric assessment of women screening positive for antenatal depression (pregnancy week 8-29) by telephone, video or in a face-to-face meeting. Assessment form allocation by chance.
Diagnostic assessment by telephone, video or face-to face - Allocation by choiceBehavioural
Structured diagnostic perinatal psychiatric assessment of women screening positive for antenatal depression (pregnancy week 8-29) by telephone, video or in a face-to-face meeting. Assessment form allocation based on patient preference.
| Study group | Role | What they receive |
|---|---|---|
| Assessment form allocated by chance & guided ICBT for antenatal depression | Active comparator | Patients are randomized to assessment modality (telephone, video or face-to-face visit) of a perinatal psychiatric semi-structured assessment \& and are randomised to treatment with internet-CBT for antenatal depression without extra-support (10 weeks) Receives: Behavioral: Therapist Guided Internet-CBT for antenatal depression; Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by chance |
| Assessment form allocated by choice & guided ICBT for antenatal depression | Active comparator | Patients choose assessment modality (telephone, video or face-to-face visit) of a perinatal psychiatric semi-structured assessment \& are randomised to treatment with internet-CBT for antenatal depression without extra-support (10 weeks) Receives: Behavioral: Therapist Guided Internet-CBT for antenatal depression; Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by choice |
| Assessment form allocated by chance & guided ICBT for antenatal depression with extra support | Experimental | Patients are randomized to assessment modality (telephone, video or face-to-face visit) of a perinatal psychiatric semi-structured assessment \& and are randomised to treatment with internet-CBT for antenatal depression with extra-support Receives: Behavioral: Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.; Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by chance |
| Assessment form allocated by choice & guided ICBT for antenatal depression with extra support | Experimental | Patients choose assessment modality (telephone, video or face-to-face visit) of a perinatal psychiatric semi-structured assessment \& are randomised to treatment with internet-CBT for antenatal depression with extra-support (10 weeks) Receives: Behavioral: Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.; Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery Asberg Depression Rating Scale, self-rating version (MADRS-S)
A 9-item self-rated measure of depression severity that also screens for suicidality (Montgomery \& Asberg, 1979). Scores range from 0 to 54 points with 13-19 points indicating mild depression, 20-34 points indicating moderate depression and 35-54 points indicating severe depression
Measured: Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Secondary outcomes (15)
Change in Edinburgh Postnatal Depression Scale (EPDS)
Self-rated measure of antenatal depression (Cox, Holden \& Sagovsky, 1987) used for screening of perinatal depression and also as a severity measure. Scores range from 0 to 30 with 13 or more points being the cut off for depression during pregnancy. This scale is validated for Swedish pregnant women (Rubertsson et al., 2011).
Measured: Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Remission of major depression (DSM-5)
Diagnostic assessment of major depression assessed by clinician in the same way as before treatment with the depression module of the SCID-I diagnostic interview based on DSM-5 (Spitzer et al., 1992).
Measured: Post-treatment (10 weeks)
Remission of major depression (DSM-5)
Diagnostic assessment of major depression assessed by clinician in the same way as before treatment with the depression module of the SCID-I diagnostic interview based on DSM-5 (Spitzer et al., 1992).
Measured: 8-10 weeks postpartum.
Change in Generalized Anxiety Disorder-7 (GAD-7)
7-item self-assessment measure of symptoms of anxiety and worry (Spitzer et al., 2006). Scores range from 0 to 21 points with 10 points and above indicating clinical levels.
Measured: Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum
Change in self-rated Insomnia Severity Index (ISI)
7-item, self-rated questionnaire measuring perceived severity of insomnia symptoms (Bastien, Vallières \& Morin, 2001). Validated as an outcome measure for insomnia research. The scale includes seven items, scored on a 0-4 scale, that are summed to a range of 0-28. The score can be divided into four categories: no clinical insomnia (0-7), subthreshold insomnia (8-14), clinical insomnia of moderate severity (15-21) and severe clinical insomnia (22-28) (Sarsour et al., 2010).
Measured: Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Change in Work and Social Adjustment Scale (WSAS)
Self-rated measure of level of impairment caused by a condition (Mundt et al. 2002). In this study two versions are used asking about impairment due to depression and due to pregnancy. Scores range from 0 to 40 with scores below 10 points indicating sub clinical impairment and scores above 20 indicating moderately severe impairment or worse.
Measured: Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Change in Euroqol (EQ-5D-5L)
Self-assessed, health related, quality of life questionnaire. 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (Hinz et al., 2014).
Measured: Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum
Change in Prenatal Attachment Inventory (PAI)
Self-rated measurement of attachment and mentalisation from the mother to the unborn child (Muller 1993; Pallant et al., 2014). 21-items scored on a 1-4 scale.
Measured: Screening to post-treatment (10 weeks)
Change in Experience of close relationships (ENR)
Self-reported measurement of adult attachment style (Brennon et al., 1998; Fraley et al., 2000; Strand \& Ståhl, 2008). 36 items scored on a 1-7 scale.
Measured: Screening to 8-10 weeks post-partum
Change in Valentine Scale
7 item self-rated scale for measurement of satisfaction with the partner relationship (Burman et al., 2018). Range 0-21 with higher values indicating higher partner relationship satisfaction.
Measured: Screening to 8-10 weeks post-partum
Change in Fear of birth scale (FOBS)
Self-assessment of fear and worry in relation to the approaching birth using two visual analogue scales (VAS)(Haines et al., 2015) with higher levels indicating increased fear and worry. Also used to assess fear and worry in relation to completed birth after delivery.
Measured: Screening to post-treatment (after 10 weeks) and to 8-10 weeks post-partum
Change in Multidimensional Scale of Perceived Social Support (MSPSS)
Measures self-rated perceived social support (Zimet et al., 1988; Ekbäck et al., 2013). 12 items rated on a seven-point Likert-type response format (1 = very strongly disagree; 7 = very strongly agree). Range 12 to 84, with higher scores indicating higher perceived social support.
Measured: Screening to 8-10 weeks post-partum
Change in Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Measures healthcare consumption and productivity loss in patients with a psychiatric disorder (Bouwmans et al., 2013).
Measured: Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Change in Clinical Global Impression Severity Scale (CGI-S)
7-item observer-rated scale that measures illness severity (CGI-S) (Guy 1976)
Measured: Post-assessment and post treatment (after week 10).
Change in Clinical Global clinical global improvement (CGI-I)
7-item observer-rated scale that measures global improvement (CGI-I) (Guy 1976).
Measured: Post-assessment and post treatment (after week 10).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start25 Feb 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
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
- Sequential
- Model description
- Multiple Assignment Randomized Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 415 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Marie Bendix, Karolinska Institutet
- Investigators
- Marie Bendix, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533138
- Sponsor's protocol ID
- 2020-06049
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2022
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided-internet Cognitive Behavioral Therapy for Antenatal Depression - Treatment Effects, Assessment Modalities and Extra Support.
- ClinicalTrials.gov ID
- NCT05533138
- Acronym / sponsor ID
- 2020-06049
- Conditions
- Antenatal Depression
- Keywords
- Cognitive behavior therapy, Internet treatment, Self-help treatment, Perinatal support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 415 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Sep 2022 (actual)
- 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.
Pregnant women in pregnancy week 8-29 screening positive for antenatal depression will be randomized to either choose or to be allotted by chance to different forms of diagnostic assessment; i.e. telephone, video or face-to-face assessment.
Those diagnosed with mild to moderate major depression will then be randomized to treatment with therapist-guided Internet-delivered Cognitive Behavioral Therapy (ICBT) adapted for women suffering from antenatal depression or to the same treatment with addition of up to three contacts with extra support by a midwife or experienced perinatal mental health nurse.
The primary aim is to assess whether extrasupport in addition to internet-guided pregnancy adapted ICBT decreases depressive symptoms more than internet-guided pregnancy adapted ICBT only. Secondary aims include effects of extrasupport and assessment mode on treatment satisfaction, fidelity and credibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Multiple Assignment Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Assessment form allocated by chance & guided ICBT for antenatal depression | Active comparator | Behavioral: Therapist Guided Internet-CBT for antenatal depression, Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by chancePatients are randomized to assessment modality (telephone, video or face-to-face visit) of a perinatal psychiatric semi-structured assessment \& and are randomised to treatment with internet-CBT for antenatal depression without extra-support (10 weeks) |
| Assessment form allocated by choice & guided ICBT for antenatal depression | Active comparator | Behavioral: Therapist Guided Internet-CBT for antenatal depression, Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by choicePatients choose assessment modality (telephone, video or face-to-face visit) of a perinatal psychiatric semi-structured assessment \& are randomised to treatment with internet-CBT for antenatal depression without extra-support (10 weeks) |
| Assessment form allocated by chance & guided ICBT for antenatal depression with extra support | Experimental | Behavioral: Therapist Guided Internet-CBT for antenatal depression and perinatal extra support., Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by chancePatients are randomized to assessment modality (telephone, video or face-to-face visit) of a perinatal psychiatric semi-structured assessment \& and are randomised to treatment with internet-CBT for antenatal depression with extra-support |
| Assessment form allocated by choice & guided ICBT for antenatal depression with extra support | Experimental | Behavioral: Therapist Guided Internet-CBT for antenatal depression and perinatal extra support., Behavioral: Diagnostic assessment by telephone, video or face-to face - Allocation by choicePatients choose assessment modality (telephone, video or face-to-face visit) of a perinatal psychiatric semi-structured assessment \& are randomised to treatment with internet-CBT for antenatal depression with extra-support (10 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Mild to moderate major depression
- Pregnant at treatment start
- Regular contact with maternity mental health clinic
- > 18 years old
- Being able to start the treatment earliest in gestational week 8 and latest in gestational week 30
Key exclusion criteria (4 listed)
- Montgomery-Åsberg Depression Rating Scale-Self report version (MADRS-S) score below 15 (symptoms of depression to low) or above 35 (severe depression)
- High risk of self harm or suicide (based on semi-structured clinical suicide risk assessment)
- Psychiatric comorbidity, disability, somatic disorder, or pregnancy complications that prevent treatment participation or that can be negatively affected or compose a risk for the fetus by treatment participation
- Ongoing psychological treatment with similar content
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 |
|---|---|---|
| Therapist Guided Internet-CBT for antenatal depressionA 10 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression adapted for antenatal depression. | Behavioural | Assessment form allocated by chance & guided ICBT for antenatal depression, Assessment form allocated by choice & guided ICBT for antenatal depression |
| Therapist Guided Internet-CBT for antenatal depression and perinatal extra support.A 10 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression adapted for antenatal depression. Additionally, up to three supportive contacts with a midwife or perinatal mental health nurse to support ICBT treatment and adress general pregnancy related health problems. | Behavioural | Assessment form allocated by chance & guided ICBT for antenatal depression with extra support, Assessment form allocated by choice & guided ICBT for antenatal depression with extra support |
| Diagnostic assessment by telephone, video or face-to face - Allocation by chanceStructured diagnostic perinatal psychiatric assessment of women screening positive for antenatal depression (pregnancy week 8-29) by telephone, video or in a face-to-face meeting. Assessment form allocation by chance. | Behavioural | Assessment form allocated by chance & guided ICBT for antenatal depression, Assessment form allocated by chance & guided ICBT for antenatal depression with extra support |
| Diagnostic assessment by telephone, video or face-to face - Allocation by choiceStructured diagnostic perinatal psychiatric assessment of women screening positive for antenatal depression (pregnancy week 8-29) by telephone, video or in a face-to-face meeting. Assessment form allocation based on patient preference. | Behavioural | Assessment form allocated by choice & guided ICBT for antenatal depression, Assessment form allocated by choice & guided ICBT for antenatal depression with extra support |
Primary outcome
Change in Montgomery Asberg Depression Rating Scale, self-rating version (MADRS-S)
Time frame: Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
A 9-item self-rated measure of depression severity that also screens for suicidality (Montgomery \& Asberg, 1979). Scores range from 0 to 54 points with 13-19 points indicating mild depression, 20-34 points indicating moderate depression and 35-54 points indicating severe depression
15 secondary outcomes
Change in Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Remission of major depression (DSM-5)
Time frame: Post-treatment (10 weeks)
Remission of major depression (DSM-5)
Time frame: 8-10 weeks postpartum.
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum
Change in self-rated Insomnia Severity Index (ISI)
Time frame: Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Change in Work and Social Adjustment Scale (WSAS)
Time frame: Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Change in Euroqol (EQ-5D-5L)
Time frame: Screening to post-treatment (10 weeks) and to 8-10 weeks post-partum
Change in Prenatal Attachment Inventory (PAI)
Time frame: Screening to post-treatment (10 weeks)
Change in Experience of close relationships (ENR)
Time frame: Screening to 8-10 weeks post-partum
Change in Valentine Scale
Time frame: Screening to 8-10 weeks post-partum
Change in Fear of birth scale (FOBS)
Time frame: Screening to post-treatment (after 10 weeks) and to 8-10 weeks post-partum
Change in Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Screening to 8-10 weeks post-partum
Change in Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Time frame: Baseline to post-treatment (10 weeks) and to 8-10 weeks post-partum
Change in Clinical Global Impression Severity Scale (CGI-S)
Time frame: Post-assessment and post treatment (after week 10).
Change in Clinical Global clinical global improvement (CGI-I)
Time frame: Post-assessment and post treatment (after week 10).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Background: 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.
- The homepage for the study where patients can registerLink provided by the sponsor.
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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.
Marie Bendix, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapist Guided Internet-CBT for antenatal depression, Therapist Guided Internet-CBT for antenatal depression and perinatal extra support. and Diagnostic assessment by telephone, video or face-to face - Allocation by chance 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 8 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: looking for participants now, as of the sponsor's last update on 25 Jun 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Bendix, PhD (+46 73 6370 864, marie.bendix@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montgomery Asberg Depression Rating Scale, self-rating version (MADRS-S) (time frame: Baseline to post-treatment (10 weeks) and to 8-10 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 NCT05533138, 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 25 Jun 2024.