Efficacy of Cognitive Restructuring and Imagery Modification to Reduce the Feeling of Being Contaminated After Childhood Sexual Abuse

May 15, 2012 updated by: Regina Steil, Goethe University

Efficacy of a Two-session Treatment of Cognitive Restructuring and Imagery Modification (CRIM) to Reduce the Feeling of Being Contaminated (FBC) in Adult Survivors of Childhood Sexual Abuse

The purpose of this study is to determine whether a short term programme with internet research on the frequency of skin exchange and guided imagery modification is effective in the treatment of the feeling of being contaminated in female victims of childhood sexual abuse (CSA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the first session the women who suffer from a feeling of being contaminated after childhood sexual abuse are interviewed with the Structured Clinical Interview for DSM-IV (SCID) to ensure the clinical diagnosis of posttraumatic stress disorder and exclude women who meet the exclusion criteria. They get questionnaires and protocol sheets to fill out until the intervention session after a week. Afterwards the women are randomly assigned to an intervention group or a waitlist control group. During the intervention session the women in the intervention group research via internet how many times their skin cells in different regions of their body have exchanged since the sexual abuse to get the information that their skin has changed hundreds and hundreds of times and has nothing in common with their skin in childhood or adolescence. This first part of the intervention is based on a component of the DBT-PTSD. Afterwards the therapist guides an imagery modification. The women imagine the feeling of being contaminated and then to peel off their former contaminated skin and the maturing of hundreds of new clean skin cells to process the rational information of the internet research emotionally. At the end of the intervention session patients get a tape with the guided imagery instruction and commit to listen to the tape daily to exercise the guided imagery modification until the third session after a week. In the last session the homework is discussed and information on posttraumatic stress disorder and psychotherapeutic treatments of posttraumatic stress disorder is offered.Women in the waitlist control group get the same treatment as the women in the intervention group after a period of five weeks.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, D-60054
        • Department of Clinical Psychology and Psychotherapy of the Johann Wolfgang Goethe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Sexual abuse in childhood or adolescence
  • Feeling of being contaminated
  • Clinical diagnosis of posttraumatic stress disorder concerning the trauma of sexual abuse in childhood or adolescence according to DSM-IV
  • Informed consent

Exclusion Criteria:

  • Currently in psychotherapy
  • Life time clinical diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-IV
  • Body mass index < 16,5
  • Endangerment of self or others
  • Clinical diagnosis of alcohol or drug addiction according to DSM-IV
  • Mental retardation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Waitlist control group
Behavioral: Waitlist control group
Patients in the wait list control group are treated after a waiting period of five weeks
Experimental: Imagery Modification
Via a internet research patients collect data on skin renewal which is discussed afterwards; in a guided imagery modification the patients imagines the process of skin renewal and the building of new skin cells
Behavioral: Imagery Modification
Research via internet concerning the frequency of skin exchange and disputation of the collected information; in the guided imagery modification the therapist instructs the patient to imagine the feeling of being contaminated and the process of peeling off their former contaminated skin and the maturing of hundreds of new clean skin cells
Other Names:
  • Cognitive Restructuring and Imagery Modification; CRIM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intensity of the feeling of being contaminated (0-100: "not at all" till "extremely")
Time Frame: pre treatment, post treatment, follow up
pre treatment, post treatment, follow up
Vividness of the feeling of being contaminated (0-100: "not at all" till "extremely")
Time Frame: pre treatment, post treatment, follow up
pre treatment, post treatment, follow up
Distress associated to the feeling of being contaminated (0-100: "not at all" till "extremely")
Time Frame: pre treatment, post treatment, follow up
pre treatment, post treatment, follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Posttraumatic Diagnostic Scale
Time Frame: pre treatment, post treatment, follow up
pre treatment, post treatment, follow up
Clinician-administered PTSD Scale
Time Frame: pre treatment, follow up
pre treatment, follow up
Rosenberg Self-esteem scale
Time Frame: pre treatment, post treatment, follow up
pre treatment, post treatment, follow up
Beck Depression Inventory (BDI-II)
Time Frame: pre treatment, post treatment, follow up
pre treatment, post treatment, follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goethe University

Investigators

  • Principal Investigator: Regina Steil, PhD, Department of Clinical Psychology and Psychotherapy of the Johann Wolfgang Goethe University of Frankfurt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

September 14, 2009

First Submitted That Met QC Criteria

September 14, 2009

First Posted (Estimate)

September 15, 2009

Study Record Updates

Last Update Posted (Estimate)

May 16, 2012

Last Update Submitted That Met QC Criteria

May 15, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDIEBESCHMUTZTHEITI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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