Keeping Well:Online Cognitive Behavioral Therapy (CBT) for Pregnant Women With Depressive Symptoms

NCT01909167 | Withdrawn

• 1 other identifier: 13IC0475
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Most depression during pregnancy is undetected and untreated although it is known to be harmful both to the woman herself and her future child. When these mental disorders are detected, psychotherapies remain difficult to access, especially in primary care, despite being effective.Also, prenatal depression is known to be a strong risk factor for postnatal depression and may prejudice the mother-infant relationship. This leads us to the following question: Will individual Cognitive Behavioral Therapy (CBT) delivered online be a more effective treatment for symptoms of depression in pregnant women, than treatment as usual (TAU)? The proposed randomized controlled trial aims at evaluating the efficacy of internet based cognitive behavioural therapy(CBT) delivered individually via "skype", using video and audio resources, by a fully trained psychotherapist, compared to treatment as usual, in women suffering from symptoms of depression in pregnancy. Hypothesis The internet based interventions will be more effective at reducing symptoms of depression in pregnant women than treatment as usual, in terms of rates of diagnoses and levels of self rated symptoms of depression.

Conditions

Anxiety; Mental Disorders; Postpartum Depression; Depressive Symptoms

Keywords

Pregnancy; symptoms of depression; anxiety; online CBT therapy; treatment as usual; maternal bonding; postnatal period

Outcome Measures

Primary Outcomes (1)

• Changes in the Edinburgh Postnatal Depression Scale (EPDS)scores from 20 weeks antenatal to 10 weeks postnatal

  The primary outcome will be the change in the EPDS scores from before to after intervention in the Cognitive Behavioral Therapy(CBT) online group compared with treatment as usual (TAU) conditions.

  Prenatal: 20, 28, 36weeks.Postnatal: 4 and 10 weeks

Secondary Outcomes (3)

• Compliance and dropout rates from 20 weeks antenatal to 4 weeks postnatal

  Prenatal: 20, 28, 36 weeks.Postnatal: 4 and 10 weeks

• Changes in anxiety scores from 20 weeks antenatal to 10 weeks postnatal

  Prenatal: 20, 28, 36 weeks.Postnatal: 4 and 10 weeks

• Changes in bonding scores at 10 weeks postnatal

  Postnatal: 10 weeks

Study Arms (2)

Treatment as usual (TAU)

ACTIVE COMPARATOR

Patients randomized to the treatment as usual arm will follow advice by their GP(general practitioner), mental health midwife or perinatal psychiatric team concerning treatment.

Other: Treatment as usual

Online Cognitive Behavioral Therapy

ACTIVE COMPARATOR

CBT treatment: Patients randomized to the online treatment will have, in total, 10 real time individual sessions of 40min each, starting at the 20-23rd gestational week and lasting until 6 weeks postpartum. The therapy will be delivered every two weeks, with a break from the 36th gestational week until the 4th week postpartum.

Behavioral: Online Cognitive Behavioral Therapy (CBT)

Interventions

Online Cognitive Behavioral Therapy (CBT) BEHAVIORAL

CBT treatment: Patients randomized to the online treatment will have, in total, 10 real time individual sessions of 40min each, starting at the 20-23rd gestational week and lasting until 6 weeks postpartum. The therapy will be delivered every two weeks, with a break from the 36th gestational week until the 4th week postpartum.

Online Cognitive Behavioral Therapy

Treatment as usual OTHER

Patients randomized to the treatment as usual arm will be advised by their GP,perinatal psychiatric team or mental health midwife concerning treatment.

Treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• To be pregnant
• Less than 20 weeks gestation,
• To have symptoms of depression (EPDS between 12-22),
• To be computer literate,
• To have an online computer at home,
• English speaking and writing,
• Not being in psychiatric or psychological treatment,
• Not having a twin pregnancy,
• Not having undertaken an IVF (In vitro fertilization) procedure,
• Not having the psychiatric problems (based on the patient's notes): psychosis, addiction, history of bipolar disorder, suicidality and other psychiatric diagnoses that do not fall into the affective disorders and/or anxiety disorders spectrum.

You may not qualify if:

• Not pregnant
• Having severe symptoms of depression (EPDS above 22),
• Computer illiteracy,
• No access to the internet,
• Not speaking or reading English,
• Already being in psychiatric or psychological treatment,
• Twin pregnancy,
• Having a medical disorder of pregnancy (including abnormal foetus),
• Having undertaken an IVF (In vitro fertilization) procedure,
• Psychiatric factors based on patient's notes: psychosis, addiction, history of bipolar disorder, suicidality and other psychiatric diagnoses that do not fall into the affective disorders and/or anxiety disorders spectrum.
• After birth for baby data: baby born below 35 weeks, baby with any severe disorders. Mothers will continue to be treated if they want to.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Queen Charlotte's and Chelsea Hospital

London, W12 0NN, United Kingdom

Location

Related Publications (11)

• Christensen H, Griffiths KM, Mackinnon AJ, Brittliffe K. Online randomized controlled trial of brief and full cognitive behaviour therapy for depression. Psychol Med. 2006 Dec;36(12):1737-46. doi: 10.1017/S0033291706008695. Epub 2006 Aug 29.

  PMID: 16938144 BACKGROUND

• Goodman JH. Women's attitudes, preferences, and perceived barriers to treatment for perinatal depression. Birth. 2009 Mar;36(1):60-9. doi: 10.1111/j.1523-536X.2008.00296.x.

  PMID: 19278385 BACKGROUND

• Hedegaard M, Henriksen TB, Sabroe S, Secher NJ. Psychological distress in pregnancy and preterm delivery. BMJ. 1993 Jul 24;307(6898):234-9. doi: 10.1136/bmj.307.6898.234.

  PMID: 8369684 BACKGROUND

• Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 2008 Feb;5(2):e45. doi: 10.1371/journal.pmed.0050045.

  PMID: 18303940 BACKGROUND

• Kessler D, Lewis G, Kaur S, Wiles N, King M, Weich S, Sharp DJ, Araya R, Hollinghurst S, Peters TJ. Therapist-delivered Internet psychotherapy for depression in primary care: a randomised controlled trial. Lancet. 2009 Aug 22;374(9690):628-34. doi: 10.1016/S0140-6736(09)61257-5.

  PMID: 19700005 BACKGROUND

• McClure EM, Goldenberg RL, Bann CM. Maternal mortality, stillbirth and measures of obstetric care in developing and developed countries. Int J Gynaecol Obstet. 2007 Feb;96(2):139-46. doi: 10.1016/j.ijgo.2006.10.010. Epub 2007 Feb 1.

  PMID: 17274999 BACKGROUND

• National Institute for Clinical Health Excellence (NICE) (2008). Technology appraisal 97: Computerized cognitive behavioural therapy for depression and anxiety (Review of technology appraisal 51), NICE, London.

  BACKGROUND

• Oates MR. Adverse effects of maternal antenatal anxiety on children: causal effect or developmental continuum? Br J Psychiatry. 2002 Jun;180:478-9. doi: 10.1192/bjp.180.6.478. No abstract available.

  PMID: 12042222 BACKGROUND

• O'Connor TG, Heron J, Golding J, Beveridge M, Glover V. Maternal antenatal anxiety and children's behavioural/emotional problems at 4 years. Report from the Avon Longitudinal Study of Parents and Children. Br J Psychiatry. 2002 Jun;180:502-8. doi: 10.1192/bjp.180.6.502.

  PMID: 12042228 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

• Vesga-Lopez O, Blanco C, Keyes K, Olfson M, Grant BF, Hasin DS. Psychiatric disorders in pregnant and postpartum women in the United States. Arch Gen Psychiatry. 2008 Jul;65(7):805-15. doi: 10.1001/archpsyc.65.7.805.

  PMID: 18606953 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Mental Disorders; Depression, Postpartum; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Officials

• Martin Kammerer, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 26, 2013
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: June 27, 2022

Record last verified: 2022-06

Locations

GB (1)