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

Primary Purpose

Obsessive-Compulsive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
psycho-education pamphlet
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Therapeutic intervention- psycho-education pamphlet

    Control group

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 22, 2017
    Last Updated
    May 29, 2017
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03172728
    Brief Title
    Psycho-education Intervention for Postpartum OCD and it's Influence on Symptom Severity and Treatment Self Referral Rates
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2017 (Anticipated)
    Primary Completion Date
    June 2019 (Anticipated)
    Study Completion Date
    June 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obsessive-Compulsive Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Therapeutic intervention- psycho-education pamphlet
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    psycho-education pamphlet
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Obsessive Compulsive Inventory-Revised questionnaire
    Description
    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.
    Time Frame
    Change from 48 hours post partum obsessive compulsive symptoms, at 8 weeks after labor.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gabi Aisenberg Romano, PhD
    Phone
    052-4262816
    Email
    gabiar@tlvmc.gov.il

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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