We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 51 for:    psychoeducation | Not yet recruiting Studies
Previous Study | Return to List | Next Study

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

This study is not yet open for participant recruitment.
Verified May 2017 by Tel-Aviv Sourasky Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03172728
First Posted: June 1, 2017
Last Update Posted: June 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
  Purpose

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.


Condition Intervention
Obsessive-Compulsive Disorder Behavioral: psycho-education pamphlet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Obsessive Compulsive Inventory-Revised questionnaire [ Time Frame: Change from 48 hours post partum obsessive compulsive symptoms, at 8 weeks after labor. ]
    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.


Estimated Enrollment: 100
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therapeutic intervention- psycho-education pamphlet

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
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.
No Intervention: Control group

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.


  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172728


Contacts
Contact: Gabi Aisenberg Romano, PhD 052-4262816 gabiar@tlvmc.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT03172728     History of Changes
Other Study ID Numbers: TASMC-16-GA-0658-CTIL
First Submitted: May 22, 2017
First Posted: June 1, 2017
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders