An interventional study of supportive call in Psychological Sequelae of Termination of Pregnancy for Fetal Anomaly, sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital. Withdrawn at 1 site in Canada. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2009-07-30.
Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Not applicable, Interventional, and Supportive care
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.
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.
980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.
This study's planned enrollment of 100 is above the median of 49 across 491 interventional studies indexed under Congenital Abnormalities.
Browse Congenital Abnormalities studies →Samuel Lunenfeld Research Institute, Mount Sinai Hospital is the lead sponsor of 135 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
-women who are currently seeing a therapist or undergoing psychiatric care, and women who do not meet all of the inclusion criteria
Subjects in the intervention group will receive supportive telephone calls biweekly for 6 months.
Behavioral: supportive call
Subjects in the control group will receive no intervention.
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.
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
This study is withdrawn, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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Samuel Lunenfeld Research Institute, Mount Sinai Hospital