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

Posttraumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976859
• Other study ID #: STUDIEBESCHMUTZTHEITI
• Status: Completed
• Phase: N/A
• First received: September 14, 2009
• Last updated: May 15, 2012
• Start date: June 2010
• Est. completion date: October 2011

Study information

• Verified date: May 2012
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Sexual Abuse
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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
• Waitlist control group
Patients in the wait list control group are treated after a waiting period of five weeks

Locations

Country	Name	City	State
Germany	Department of Clinical Psychology and Psychotherapy of the Johann Wolfgang Goethe University	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of the feeling of being contaminated (0-100: "not at all" till "extremely")		pre treatment, post treatment, follow up	No
Primary	Vividness of the feeling of being contaminated (0-100: "not at all" till "extremely")		pre treatment, post treatment, follow up	No
Primary	Distress associated to the feeling of being contaminated (0-100: "not at all" till "extremely")		pre treatment, post treatment, follow up	No
Secondary	Posttraumatic Diagnostic Scale		pre treatment, post treatment, follow up	No
Secondary	Clinician-administered PTSD Scale		pre treatment, follow up	No
Secondary	Rosenberg Self-esteem scale		pre treatment, post treatment, follow up	No
Secondary	Beck Depression Inventory (BDI-II)		pre treatment, post treatment, follow up	No