Psycho-education Intervention for Postpartum OCD and it's Influence on Symptom Severity and Treatment Self Referral Rates

Psycho-education Intervention for Postpartum Obsessive Compulsive Disorder (OCD) and it's Influence on Symptom Severity and Treatment Self Referral Rates: A Prospective Randomized Double Blinded Control Trial

Sponsors

Lead Sponsor: Tel-Aviv Sourasky Medical Center

Source Tel-Aviv Sourasky Medical Center
Brief Summary

The rationale for conducting the experiment including quantitative measures and a description of the method of recruitment: This study provides psycho-educational intervention aimed at raising awareness of post partum Obsessive-Compulsive disorder (OCD) , reducing the intensity of symptoms and increase of self referral to treatment. Various studies report that 1-11% of women after childbirth suffer from OCD. A part of this population suffered from the disorder prior to giving birth and for some this is a first outbreak. This is a psychological disorder characterized by obsessions and compulsions. The disorder can appear or worsen at any time , and is characterized by different content depending on the stage of life. Obsessional thoughts after birth often includes harming the baby which alarms the woman and the surrounding, and affects her ability to care for the baby and develop a beneficial relationship with him. Studies support a bio-psycho-social model of OCD .and that adjustment period and physical changes after childbirth can be create a psychological biological and environmental background, to the development or worsening of OCD in women who suffer from or are prone to the disorder. The present study deals with psycho-educational information which will be given to women after birth who were identified as susceptible to develop OCD. The information will be delivered in the maternity ward through written and recorded data , and sent through the system Qualtrics 4 weeks after birth. Psycho-education is an important first step in Cognitive Behavioral therapy for OCD and may lead to anxiety reduction and commitment to treatment. The information sent in the study is similar to the information provided at the beginning of standard Cognitive Behavioral Therapy.Women will be recruited from the maternity ward at Lis Maternity Hospital. In order to identify women at risk for OCD, All women in the maternity ward will be asked to fill a short questionnaire. Women found at risk or as suffering from OCD will be invited to participate in the study.

Overall Status Unknown status
Start Date 2017-06-01
Completion Date 2020-06-01
Primary Completion Date 2019-06-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Obsessive Compulsive Inventory-Revised questionnaire Change from 48 hours post partum obsessive compulsive symptoms, at 8 weeks after labor.
Enrollment 100
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: psycho-education pamphlet

Description: psycho-education intervention, based on Cognitive Behavioral Therapy, that is easy to provide and feasible in standard perinatal care. It is intended to increase awareness of obsessive thoughts and to decrease anxiety and encourage treatment seeking.

Arm Group Label: Therapeutic intervention- psycho-education pamphlet

Eligibility

Criteria:

Inclusion Criteria: - Women are 48 hours after birth, meet the criteria for OCS (obsessive compulsive symptoms) or have previous history of OCD. - Capable of filling computerized questionnaires. - Capable of giving informed consent. Exclusion Criteria: - Substance use

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

45 Years

Healthy Volunteers:

No

Overall Contact Contact information is only displayed when the study is recruiting subjects.
Verification Date

2017-05-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Therapeutic intervention- psycho-education pamphlet

Type: Experimental

Description: Psycho-education information (appendix 1) will be provided by research assistant in a pamphlet and audio recording, with a written referral to the women's mental health services in case symptoms arise. This psycho-education information will be sent again by Qualtrics 4 weeks later and women will be prompted to read it again. Women who do not respond within a week will be contacted by a research assistant and reminded to respond. In the end of the reading material, there will be a reading confirmation question. In the case that a participant will not answer this question or if the answer will suggest that the participant did not read the material, the research assistant will contact her by phone to confirm the reading.

Label: Control group

Type: No Intervention

Description: Control group will receive general psychoeducation about the emotional after effects of childbirth in a pamphlet and audio recording and the phone number for the women's mental health services. This psychoeducation information will be sent again by Qualtrics 4 weeks later and women will be prompted to read it again. Women who do not respond will be contacted by a research assistant within a week and reminded to respond. In the end of the reading material, there will be a reading confirmation question. In the case that a participant will not answer this question or if the answer will suggest that the participant did not read the material, the research assistant will contact her by phone to confirm the reading.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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