Internet CBT for Antenatal Depression

Recruiting · NCT05533138 · Interventional (participants receive a specific treatment) · Lead sponsor: Karolinska Institutet

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Depression

Interventions studied

Diagnostic assessment by telephone, video or face-to face - Allocation by chanceDiagnostic assessment by telephone, video or face-to face - Allocation by choiceTherapist Guided Internet-CBT for antenatal depressionTherapist Guided Internet-CBT for antenatal depression and perinatal extra support.

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

Female

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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

Exclusion criteria

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

Where it is running

1 location listed.

Psychiatry Southwest, Department of CL Psychiatry & Internetpsychiatry - Stockholm, Sweden

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →