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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Goethe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDIEBESCHMUTZTHEITI

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