Well Being And Resilience: Mechanisms of Transmission of Health and Risk (WARM)

Susanne Harder

Status: Completed

Conditions: Bipolar Disorder; Psychotic Disorder; Depressive Disorder

Treatments: Other: Biological and psycho-social risk and resilience factors

Study type: Observational

Funder types: Other

Identifiers

NCT02306551

DFF-1319-00103

Details and patient eligibility

About

The purpose of this study is to establish a cohort of pregnant women with severe mental disorder and to identify biological and psycho-social transmission mechanisms involved in the development of 'risk' and 'resilience' in the offspring. It is assumed that both 'resilient' and 'risk' development in offspring are caused by a complex interaction between multiple biological, psychological and social factors. The project focuses specifically on exploring the impact of physiological stress-sensitivity, attachment, care-giving and the familial and social context for care-giving. Previous studies support these factors as important for the development of these infants, but systematic research using a prospective design is needed to strengthen evidence and elucidate the importance of these factors in more detail. The interaction over time of physiological stress-sensitivity, attachment, care-giving and the familial and social context for care-giving are evaluated in terms of the evolution of very early indicators of developmental risk and resilience in infants with a known highly increased risk for developing a mental disorder.The findings of the study may potentially lead to more specific targets for preventive interventions, which can improve developmental outcome for these infants.

Enrollment: 93 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women with Psychotic Disorder (DSM-5: Delusional Disorder (297.1)
• Schizophreniform Disorder (295.4), Schizophrenia (295.90), Schizoaffective Disorder (295.70)
• Brief Psychotic Disorder (298.8) Other specified schizophrenia spectrum and other psychotic disorder (298.8), Unspecified schizophrenia spectrum and other psychotic disorder (298.9) )
• Lifetime diagnosis of DSM-5 Bipolar I and II Disorder (296.89)
• Diagnosis of DSM-5 Major Depressive Disorder current single episode (current 296.22 - 296.25) or recurrent episode (296.32 - 296.35)
• Non-psychiatric control group defined as mothers without any history of treatment or admission for a psychiatric disorder or drug or alcohol addiction.
• Partners of participating women with an expected care-giving role in relation to the infant will also be eligible for participation in the study.
• Infants of participating pregnant women will be included from birth.

Exclusion criteria

• Unable to provide informed consent to participate
• Unable to speak English or Danish because of the requirement to complete assessments,
• Miscarriage.

Trial design

93 participants in 4 patient groups

Psychotic Disorder

Description:

Biological and psycho-social risk and resilience factors

Treatment:

Other: Biological and psycho-social risk and resilience factors

Bipolar Disorder

Description:

Biological and psycho-social risk and resilience factors

Treatment:

Other: Biological and psycho-social risk and resilience factors

Depressive Disorder

Description:

Biological and psycho-social risk and resilience factors

Treatment:

Other: Biological and psycho-social risk and resilience factors

Non-psychiatric Control

Description:

Biological and psycho-social risk and resilience factors

Treatment:

Other: Biological and psycho-social risk and resilience factors