Impact of a Telephone-based Support Intervention on the Long-term Well-being of Women Undergoing Termination of Pregnancy for Fetal Anomaly (TOPFA)
This study focuses on women undergoing termination of pregnancy for fetal anomalies (TOPFA). Psychological consequences of such terminations may be even greater than those associated with spontaneous losses of pregnancy because of shame and guilt which can result in social isolation. Currently, there is little support for women after they have left hospital. In this study, 50 TOPFA women will be randomly assigned to an intervention group and 50 to a control group. By completing four questionnaires at the time of induction of labour, total sample will be assessed for depression, stress and "hardiness"; they will be reassessed at 3, 6, and 12 months. Total sample will be interviewed by phone at 6 and 12 months. We hope to determine whether a telephone-based intervention (a biweekly supportive call) can decrease the emotional distress experienced by women undergoing termination of pregnancy.
Psychological Sequelae of Termination of Pregnancy for Fetal Anomaly
Behavioral: supportive call
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||The Impact of a Telephone-based Support Intervention on the Long-term Well-being of Women Undergoing Termination of Pregnancy for Fetal Anomaly|
- At time of induction of labour and at 3, 6, and 12 months post-TOPFA: scores on the Beck Depression Inventory, the Impact of Events Scale, the Lang and Goulet Hardiness Scale,the Relationship Scales Questionnaire [ Time Frame: One year ]
- Total sample will be interviewed by telephone at 6 and 12 months post-TOPFA [ Time Frame: One year ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||September 2009|
Subjects in the intervention group will receive supportive telephone calls biweekly for 6 months.
Behavioral: supportive call
Each subject in the intervention group will receive a 10 minute (or longer) biweekly telephone call from a psychologist intended to provide non-judgemental support to TOPFA women with the aim of reducing depression, guilt, isolation, shame, marital discord, and other common psychological sequelae of termination for fetal anomalies.
No Intervention: B
Subjects in the control group will receive no intervention.
We hypothesize that: 1)women in the intervention group will show lower rates of depression and stress and a significant increase in hardiness over time at 6 and 12 months post-termination compared with the control group; 2) women who score low on hardiness initially will experience more psychological distress at 6 and 12 months than subjects who score higher initially, irrespective of group; 3) women who have anxious/avoidant attachment styles will not show an improvement in psychological distress over time, irrespective of group.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576212
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Principal Investigator:||Eileen Sloan, PhD MD FRCP||Mount Sinai Hospital, Canada|