Major Depressive Disorder Clinical Trial
Official title:
Willkommen Mutterglück: A Controlled Trial of Internet Based Cognitive Behavioural Therapy (CBT) for Pregnant and Postpartum Women With Depression and Anxiety
This intervention study aims to evaluate the effectivity of web-based cognitive therapy in
reducing depression and anxiety in pregnant and postpartum women. Moreover, it aims to assess
treatment feasibility and usability of the treatment in the same population.
After an initial screening to determine the eligibility to participate, all participants
fulfilling the inclusion criteria will receive their personal access login in order to start
the intervention.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | January 2024 |
Est. primary completion date | January 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - pregnant women or women who had given birth in the last year - between 18 and 45 years old - minor to moderate depression and/or generalised anxiety disorder - fluent in German - having a computer, laptop or handheld device with internet access Exclusion Criteria: - women with a severe medical disorder or a severe psychological disorder such as psychosis, drug addiction and other substance abuse - women taking psychotropic medication - women with current suicidality - women who are currently receiving psychological treatment for depression or anxiety |
Country | Name | City | State |
---|---|---|---|
Switzerland | University of Zurich, Department of Psychology - Clinical Psychology and Psychotherapy | Zürich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich | Ambulatorium für kognitive Verhaltenstherapie und Verhaltensmedizin - UZH, Lamprecht AG |
Switzerland,
Alder J, Urech C. Angststörungen in der Schwangerschaft. In: Riecher-Rössler A, eds. Psychische Erkrankungen in Schwangerschaft und Stillzeit. Basel, Switzerland: Karger; 2014.
Amiel Castro R, Glover V, Kammerer M, Ehlert U. Associations between maternal symptoms of depression, coping strategies and infant temperament: A longitudinal study from pregnancy to postpartum, Manuscript submitted for publication.
Amiel Castro RT, Pinard Anderman C, Glover V, O'Connor TG, Ehlert U, Kammerer M. Associated symptoms of depression: patterns of change during pregnancy. Arch Womens Ment Health. 2017 Aug;20(4):593-594. doi: 10.1007/s00737-017-0728-7. Epub 2017 May 25. — View Citation
Andersson G, Titov N. Advantages and limitations of Internet-based interventions for common mental disorders. World Psychiatry. 2014 Feb;13(1):4-11. doi: 10.1002/wps.20083. — View Citation
Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One. 2010 Oct 13;5(10):e13196. doi: 10.1371/journal.pone.0013196. — View Citation
Baer N, Schuler D, Moreau-gruet F. Depressionen in der Schweizer Bevölkerung Daten zur Epidemiologie, Behandlung und sozial-beruflichen Integration. Obsan Bericht 56, 2013.
Barnes M, Cox J, Doyle B, Reed R. Evaluation of a practice-development initiative to improve breastfeeding rates. J Perinat Educ. 2010 Fall;19(4):17-23. — View Citation
Bergant AM, Nguyen T, Heim K, Ulmer H, Dapunt O. [German language version and validation of the Edinburgh postnatal depression scale]. Dtsch Med Wochenschr. 1998 Jan 16;123(3):35-40. German. — View Citation
Carter D, Kostaras X. Psychiatric disorders in pregnancy. British Columbia Medical Journal 47(2): 96-100, 2005.
Dunkel Schetter C, Tanner L. Anxiety, depression and stress in pregnancy: implications for mothers, children, research, and practice. Curr Opin Psychiatry. 2012 Mar;25(2):141-8. doi: 10.1097/YCO.0b013e3283503680. Review. — View Citation
Ehlert U, Patalla U, Kirschbaum C, Piedmont E, Hellhammer DH. Postpartum blues: salivary cortisol and psychological factors. J Psychosom Res. 1990;34(3):319-25. — View Citation
Gast U, Oswald T, Zündorf F, Hofmann A. SKID-D- Strukturiertes Klinisches Interview für DSM-IV. Dissoziative Störungen Manual. Göttingen, Germany: Hogrefe; 2000.
Grant KA, McMahon C, Austin MP. Maternal anxiety during the transition to parenthood: a prospective study. J Affect Disord. 2008 May;108(1-2):101-11. Epub 2007 Nov 14. — View Citation
Griffiths KM, Farrer L, Christensen H. The efficacy of internet interventions for depression and anxiety disorders: a review of randomised controlled trials. Med J Aust. 2010 Jun 7;192(S11):S4-11. Review. — View Citation
Hautzunger M, Keller F, Kühner C. Beck Depressions-Inventar Revision. Manual. München, Germany: Pearson; 2009.
Hofmann SG, Asnaani A, Vonk IJ, Sawyer AT, Fang A. The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427-440. Epub 2012 Jul 31. — View Citation
Löwe B, Zipfel S, Herzog W. Deutsche Übersetzung und Validierung des Brief Patient Health Questionnaire (Brief PHQ). Medizinische Universitätsklinik Heidelberg, Germany: AOK, no date.
Margraf J, Ehlers A. Beck-Angst-Inventar. Manual. München, Germany: Pearson; 2007.
O'Connor TG, Heron J, Glover V; Alspac Study Team. Antenatal anxiety predicts child behavioral/emotional problems independently of postnatal depression. J Am Acad Child Adolesc Psychiatry. 2002 Dec;41(12):1470-7. — View Citation
O'Hara MW, Swain AM. Rates and risk of postpartum depression-a meta-analysis. International Review of Psychiatry 8(1): 37-54, 1996.
Oates MR. Perinatal psychiatric syndromes: clinical features. Psychiatry, 5(1): 5-9, 2006.
Pössel P, Seemann S, Hautzinger M. Evaluation eines deutschsprachigen Instrumentes zur Erfassung positiver und negativer automatischer Gedanken. Evaluation of a German-language instrument for assessing positive and negative automatic thoughts. Zeitschrift Für Klinische Psychologie Und Psychotherapie: Forschung Und Praxis 34(1): 27-34, 2005.
Richards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012 Jun;32(4):329-42. doi: 10.1016/j.cpr.2012.02.004. Epub 2012 Feb 28. — View Citation
Rummel B, Ruegenhagen E, Reinhardt W. Fragebogen zur System-Gebrauchstauglichkeit; 2013.
Sourander A, McGrath PJ, Ristkari T, Cunningham C, Huttunen J, Lingley-Pottie P, Hinkka-Yli-Salomäki S, Kinnunen M, Vuorio J, Sinokki A, Fossum S, Unruh A. Internet-Assisted Parent Training Intervention for Disruptive Behavior in 4-Year-Old Children: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Apr;73(4):378-87. doi: 10.1001/jamapsychiatry.2015.3411. — View Citation
Talge NM, Neal C, Glover V; Early Stress, Translational Research and Prevention Science Network: Fetal and Neonatal Experience on Child and Adolescent Mental Health. Antenatal maternal stress and long-term effects on child neurodevelopment: how and why? J Child Psychol Psychiatry. 2007 Mar-Apr;48(3-4):245-61. Review. — View Citation
Zaers S, Waschke M, Ehlert U. Depressive symptoms and symptoms of post-traumatic stress disorder in women after childbirth. J Psychosom Obstet Gynaecol. 2008 Mar;29(1):61-71. doi: 10.1080/01674820701804324. — View Citation
* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of depressive symptoms at four measuring points from baseline to follow up | Measured with Beck's Depression Inventory (BDI) | At baseline, during week 4, 8, 16 of the intervention and at one month after completing intervention. | |
Primary | Change of anxiety symptoms at four measuring points from baseline to follow up | Measured with Beck's Anxiety Inventory (BAI) | At baseline, during week 4, 8, 16 of the intervention and at one month after completing intervention. | |
Primary | Change of severity of depressive symptoms at four measuring points from baseline to follow up | Measured with Patient Health Questionnaire (PHQ) Ranges from 0-27 (0-4=none-minimal; 5-9=mild; 10-14=moderate; 15-19=moderately severe; 20-27=severe) | At baseline, during week 4, 8, 16 of the intervention and at one month after completing intervention. | |
Primary | Change of depression symptoms from baseline until follow-up | Measured with Edinburgh Postnatal Depression Scale (EPDS) Minimum score = 0, maximum score = 30. Cut off value is set at 12/13 | At baseline and during week 16 of the intervention | |
Secondary | Participant's satisfaction with the program and it's usability | This is reported with open-ended questions about satisfaction with the program and with self-report measure that assesses the patient's attitude on the overall usability to the program (System Usability Scale, SUS) The scores range from 0-100. It is agreed that score above 68 would be considered above average, whilst scores below 68 would be considered below average. | At week 16 of the intervention | |
Secondary | Program's evaluation of feasibility with prenatal and postpartum women | This is reported with user engagement, such as duration spent on web-intervention-site and number of log-ins into the intervention. These different measures should give an overview over how the participants perceive and evaluate the program and how they rate its feasibility. | From baseline until 1 month follow-up of the intervention |
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