Efficacy of Cognitive Restructuring and Imagery Modification to Reduce the Feeling of Being Contaminated After Childhood Sexual Abuse
Primary Purpose
Sexual Abuse, Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Imagery Modification
Waitlist control group
Sponsored by
About this trial
This is an interventional treatment trial for Sexual Abuse focused on measuring childhood sexual abuse, CSA, posttraumatic stress disorder, PTSD, feeling of being polluted, mental pollution, mental contamination, feeling of being contaminated, sexual assault, disgust, shame
Eligibility 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
Sites / Locations
- Department of Clinical Psychology and Psychotherapy of the Johann Wolfgang Goethe University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Waitlist control group
Imagery Modification
Arm Description
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
Outcomes
Primary Outcome Measures
Intensity of the feeling of being contaminated (0-100: "not at all" till "extremely")
Vividness of the feeling of being contaminated (0-100: "not at all" till "extremely")
Distress associated to the feeling of being contaminated (0-100: "not at all" till "extremely")
Secondary Outcome Measures
Posttraumatic Diagnostic Scale
Clinician-administered PTSD Scale
Rosenberg Self-esteem scale
Beck Depression Inventory (BDI-II)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00976859
Brief Title
Efficacy of Cognitive Restructuring and Imagery Modification to Reduce the Feeling of Being Contaminated After Childhood Sexual Abuse
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Goethe University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Abuse, Posttraumatic Stress Disorder
Keywords
childhood sexual abuse, CSA, posttraumatic stress disorder, PTSD, feeling of being polluted, mental pollution, mental contamination, feeling of being contaminated, sexual assault, disgust, shame
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Title
Imagery Modification
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Imagery Modification
Other Intervention Name(s)
Cognitive Restructuring and Imagery Modification; CRIM
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Waitlist control group
Intervention Description
Patients in the wait list control group are treated after a waiting period of five weeks
Primary Outcome Measure Information:
Title
Intensity of the feeling of being contaminated (0-100: "not at all" till "extremely")
Time Frame
pre treatment, post treatment, follow up
Title
Vividness of the feeling of being contaminated (0-100: "not at all" till "extremely")
Time Frame
pre treatment, post treatment, follow up
Title
Distress associated to the feeling of being contaminated (0-100: "not at all" till "extremely")
Time Frame
pre treatment, post treatment, follow up
Secondary Outcome Measure Information:
Title
Posttraumatic Diagnostic Scale
Time Frame
pre treatment, post treatment, follow up
Title
Clinician-administered PTSD Scale
Time Frame
pre treatment, follow up
Title
Rosenberg Self-esteem scale
Time Frame
pre treatment, post treatment, follow up
Title
Beck Depression Inventory (BDI-II)
Time Frame
pre treatment, post treatment, follow up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Regina Steil, PhD
Organizational Affiliation
Department of Clinical Psychology and Psychotherapy of the Johann Wolfgang Goethe University of Frankfurt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Psychology and Psychotherapy of the Johann Wolfgang Goethe University
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
D-60054
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.studie.uni-frankfurt.de
Description
Related Info
Learn more about this trial
Efficacy of Cognitive Restructuring and Imagery Modification to Reduce the Feeling of Being Contaminated After Childhood Sexual Abuse
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