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

NCT03172728 | Unknown

• 1 other identifier: TASMC-16-GA-0658-CTIL
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• Obsessive Compulsive Inventory-Revised questionnaire

  The Obsessive-Compulsive Inventory (OCI) was developed to help determine the severity of obsessive compulsive disorder (OCD). The OCI consists of 42 items composing 7 subscales: Washing, Checking, Doubting, Ordering, Obsessing (i.e. having obsessional thoughts), Hoarding, and Mental Neutralising. Each item is rated on a 5-point (0-4) scale of symptom distress.

  Change from 48 hours post partum obsessive compulsive symptoms, at 8 weeks after labor.

Study Arms (2)

Therapeutic intervention- psycho-education pamphlet

EXPERIMENTAL

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.

Behavioral: psycho-education pamphlet

Control group

NO INTERVENTION

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.

Interventions

psycho-education pamphlet BEHAVIORAL

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.

Therapeutic intervention- psycho-education pamphlet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Substance use

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

Gabi Aisenberg Romano, PhD

CONTACT

052-4262816; gabiar@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: June 1, 2017
• Study Start: June 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2020
• Last Updated: June 1, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share