Brains, Babies & Bodies: A group psychological intervention for pregnant women living with bipolar disorder – a pilot feasibility and acceptability study

Not Applicable

• Conditions: Bipolar Disorder; Mental Health - Other mental health disorders

• Registration Number: ACTRN12623000354684
• Lead Sponsor: Western Sydney University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-05
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

Inclusion Criteria: Diagnosis of bipolar disorder, female, over the age of 18 years, currently pregnant, currently under the care of a psychiatrist or GP with written approval from primary clinician to participate, not actively suicidal or experiencing severe mood symptoms (score of greater than 38 on the YMRS and 35 on the MADRS (Young, Biggs, Ziegler, & Meyer, 1978; Müller, Szegedi, Wetzel & Benkert, 2000).

Exclusion Criteria

nil diagnosis of bipolar disorder, male or female and not pregnant under the age of 18 years, not currently under care of GP or psychiatrist, or primary clinician deems participant not eligible. Participants will also be excluded if they are actively suicidal or experiencing severe mood symptoms (score of greater than 38 on the YMRS and 35 on the MADRS (Young, Biggs, Ziegler, & Meyer, 1978; Müller, Szegedi, Wetzel & Benkert, 2000).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Drop out/retention rate<br>This is assessed at the completion of the program through an audit of attendance.[Post-completion of the intervention (8 weeks post-baseline)]

Secondary Outcome Measures

Name	Time	Method
Mean number of sessions attended<br>Calculated at the conclusion of the study based through an audit of attendance.[Post-completion of the intervention (8 weeks post-baseline)];Qualitative feedback overall regarding content of the program. This will be assessed using a semi-structured interview. This includes questions relating to the content of the program and delivery[Post-completion of the intervention (8 weeks post-baseline)];Completion of wellbeing plan. The extent of the well-being plan that is completed is assessed by an audit of the study records.[Post-completion of the intervention (8 weeks post-baseline).]