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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regina Steil, Goethe University
ClinicalTrials.gov Identifier:
NCT00976859
First received: September 14, 2009
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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).


Condition Intervention
Sexual Abuse
Posttraumatic Stress Disorder
Behavioral: Imagery Modification
Behavioral: Waitlist control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Goethe University:

Primary Outcome Measures:
  • Intensity of the feeling of being contaminated (0-100: "not at all" till "extremely") [ Time Frame: pre treatment, post treatment, follow up ] [ Designated as safety issue: No ]
  • Vividness of the feeling of being contaminated (0-100: "not at all" till "extremely") [ Time Frame: pre treatment, post treatment, follow up ] [ Designated as safety issue: No ]
  • Distress associated to the feeling of being contaminated (0-100: "not at all" till "extremely") [ Time Frame: pre treatment, post treatment, follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Posttraumatic Diagnostic Scale [ Time Frame: pre treatment, post treatment, follow up ] [ Designated as safety issue: No ]
  • Clinician-administered PTSD Scale [ Time Frame: pre treatment, follow up ] [ Designated as safety issue: No ]
  • Rosenberg Self-esteem scale [ Time Frame: pre treatment, post treatment, follow up ] [ Designated as safety issue: No ]
  • Beck Depression Inventory (BDI-II) [ Time Frame: pre treatment, post treatment, follow up ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: June 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Cognitive Restructuring and Imagery Modification; CRIM

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976859

Locations
Germany
Department of Clinical Psychology and Psychotherapy of the Johann Wolfgang Goethe University
Frankfurt, Hessen, Germany, D-60054
Sponsors and Collaborators
Goethe University
Investigators
Principal Investigator: Regina Steil, PhD Department of Clinical Psychology and Psychotherapy of the Johann Wolfgang Goethe University of Frankfurt
  More Information

Additional Information:
No publications provided

Responsible Party: Regina Steil, PhD, Goethe University
ClinicalTrials.gov Identifier: NCT00976859     History of Changes
Other Study ID Numbers: STUDIEBESCHMUTZTHEITI
Study First Received: September 14, 2009
Last Updated: May 15, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Goethe University:
childhood sexual abuse
CSA
posttraumatic stress disorder
PTSD, feeling of being polluted
mental pollution, mental contamination
feeling of being contaminated
sexual assault
disgust, shame

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 21, 2014