Willkommen Mutterglück: Online CBT for Pregnant and Postpartum Women With Depression and Anxiety

NCT04183946 | Unknown DMC

• 1 other identifier: Willkommen Mutterglück Program
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prenatal Anxiety; Generalized Anxiety; Postpartum Depression; Major Depressive Disorder

Keywords

generalized anxiety disorder; depression; cognitive behavioral therapy; web-based cognitive behavioural therapy; web-based CBT; pregnancy; prenatal depression; prenatal anxiety; postpartum anxiety; postpartum depression

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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 Outcomes (2)

• Participant's satisfaction with the program and it's usability

  At week 16 of the intervention

• Program's evaluation of feasibility with prenatal and postpartum women

  From baseline until 1 month follow-up of the intervention

Study Arms (1)

Online Cognitive Behavioural Therapy

OTHER

Screened participants diagnosed with minor to moderate anxiety and/or depression will receive online CBT therapy (8 interactive sessions) aiming to treat their symptomatology. Each session can be completed at one's own pace.

Behavioral: Online Cognitive Behavioural Therapy

Interventions

Online Cognitive Behavioural Therapy BEHAVIORAL

The "Willkommen Mutterglück" program is an 8-session, interactive web-based CBT intervention for prenatal and postpartum depression and anxiety. The sessions are administered online via audio and video images. Each weekly session has a duration of 40-50 minutes during which the participants are asked to actively participate through exercises and quizzes. A SCID interview for screening will be conducted by a trained clinical psychologist and an experienced psychiatrist from our outpatient clinic will verify the diagnosis. Screened and consented participants will answer baseline questionnaires, provide sociodemographic information and receive a private login to access the program. After completing the 2nd, 4th and 8th intervention session participants will fill in psychological questionnaires. During the intervention, participants will be contacted three times by telephone by coaches (psychotherapists in training) who follow a manualized script.

Also known as: Willkommen Mutterglück: Online CBT program for pre-postnatal depression & anxiety

Online Cognitive Behavioural Therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Ambulatorium für kognitive Verhaltenstherapie und Verhaltensmedizin - UZH: collaborator
• Lamprecht AG: collaborator

Study Sites (1)

University of Zurich, Department of Psychology - Clinical Psychology and Psychotherapy

Zurich, 8050, Switzerland

Location

Related Publications (27)

• 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. No abstract available.

  PMID: 28540597 BACKGROUND

• 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.

  PMID: 24497236 BACKGROUND

• 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.

  PMID: 20967242 BACKGROUND

• 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. doi: 10.1624/105812410X530893.

  PMID: 21886418 BACKGROUND

• 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. doi: 10.1016/0022-3999(90)90088-l.

  PMID: 2342000 BACKGROUND

• 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. doi: 10.1016/j.jad.2007.10.002. Epub 2007 Nov 14.

  PMID: 18001841 BACKGROUND

• 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. doi: 10.5694/j.1326-5377.2010.tb03685.x.

  PMID: 20528707 BACKGROUND

• 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. doi: 10.1007/s10608-012-9476-1. Epub 2012 Jul 31.

  PMID: 23459093 BACKGROUND

• 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. doi: 10.1097/00004583-200212000-00019.

  PMID: 12447034 BACKGROUND

• 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.

  PMID: 22466510 BACKGROUND

• 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.

  PMID: 22262028 BACKGROUND

• Sourander A, McGrath PJ, Ristkari T, Cunningham C, Huttunen J, Lingley-Pottie P, Hinkka-Yli-Salomaki 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.

  PMID: 26913614 BACKGROUND

• 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. doi: 10.1111/j.1469-7610.2006.01714.x.

  PMID: 17355398 BACKGROUND

• 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.

  PMID: 18266166 BACKGROUND

• Alder J, Urech C. Angststörungen in der Schwangerschaft. In: Riecher-Rössler A, eds. Psychische Erkrankungen in Schwangerschaft und Stillzeit. Basel, Switzerland: Karger; 2014.

  BACKGROUND

• 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.

  BACKGROUND

• Baer N, Schuler D, Moreau-gruet F. Depressionen in der Schweizer Bevölkerung Daten zur Epidemiologie, Behandlung und sozial-beruflichen Integration. Obsan Bericht 56, 2013.

  BACKGROUND

• 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. doi: 10.1055/s-2007-1023895. German.

  PMID: 9472218 BACKGROUND

• Carter D, Kostaras X. Psychiatric disorders in pregnancy. British Columbia Medical Journal 47(2): 96-100, 2005.

  BACKGROUND

• Gast U, Oswald T, Zündorf F, Hofmann A. SKID-D- Strukturiertes Klinisches Interview für DSM-IV. Dissoziative Störungen Manual. Göttingen, Germany: Hogrefe; 2000.

  BACKGROUND

• Hautzunger M, Keller F, Kühner C. Beck Depressions-Inventar Revision. Manual. München, Germany: Pearson; 2009.

  BACKGROUND

• Löwe B, Zipfel S, Herzog W. Deutsche Übersetzung und Validierung des Brief Patient Health Questionnaire (Brief PHQ). Medizinische Universitätsklinik Heidelberg, Germany: AOK, no date.

  BACKGROUND

• Margraf J, Ehlers A. Beck-Angst-Inventar. Manual. München, Germany: Pearson; 2007.

  BACKGROUND

• Oates MR. Perinatal psychiatric syndromes: clinical features. Psychiatry, 5(1): 5-9, 2006.

  BACKGROUND

• O'Hara MW, Swain AM. Rates and risk of postpartum depression-a meta-analysis. International Review of Psychiatry 8(1): 37-54, 1996.

  BACKGROUND

• 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.

  BACKGROUND

• Rummel B, Ruegenhagen E, Reinhardt W. Fragebogen zur System-Gebrauchstauglichkeit; 2013.

  BACKGROUND

Related Links

• Pregnancy related research by the University of Zurich

MeSH Terms

Conditions

Generalized Anxiety Disorder; Depression, Postpartum; Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Behavioral Symptoms; Behavior

Study Officials

• Ulrike Ehlert, Prof. Dr.

  University of Zurich, Department of Psychology - Clinical Psychology and Psychotherapy

  STUDY CHAIR

• Rita Amiel Castro, Dr. phil.

  University of Zurich, Department of Psychology - Clinical Psychology and Psychotherapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita Amiel Castro, Dr. phil.

CONTACT

+41 44 635 73 42; r.castro@psychologie.uzh.ch

Ulrike Ehlert, Prof. Dr.

CONTACT

+41 44 635 73 50; u.ehlert@psychologie.uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: December 3, 2019
• Study Start: June 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2024
• Last Updated: December 3, 2019

Record last verified: 2019-11

Locations

CH (1)