Sexual AbuseNCT00976859
Efficacy of Cognitive Restructuring and Imagery Modification to Reduce the Feeling of Being Contaminated After Childhood Sexual Abuse
A study testing Imagery Modification in people with Sexual Abuse and Posttraumatic Stress Disorder, run by Goethe University at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Sexual Abuse, Posttraumatic Stress Disorder
- What is being tested?
- Imagery Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2010to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Clinical Psychology and Psychotherapy of the Johann Wolfgang Goethe University
Frankfurt am Main, Hesse, D-60054
About this study
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
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).
Read the 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.
- Conditions
- Sexual Abuse, Posttraumatic Stress Disorder
- Being tested
- Imagery Modification, Waitlist control group
- 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
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagery ModificationBehavioural
Also called Cognitive Restructuring and Imagery Modification; CRIM
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 groupBehavioural
Patients in the wait list control group are treated after a waiting period of five weeks
| Study group | Role | What they receive |
|---|---|---|
| Waitlist control group | No intervention | Not described Receives: Behavioral: Waitlist control group |
| Imagery Modification | Experimental | 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 Receives: Behavioral: Imagery Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of the feeling of being contaminated (0-100: "not at all" till "extremely")
Measured: pre treatment, post treatment, follow up
Vividness of the feeling of being contaminated (0-100: "not at all" till "extremely")
Measured: pre treatment, post treatment, follow up
Distress associated to the feeling of being contaminated (0-100: "not at all" till "extremely")
Measured: pre treatment, post treatment, follow up
Secondary outcomes (4)
Posttraumatic Diagnostic Scale
Measured: pre treatment, post treatment, follow up
Clinician-administered PTSD Scale
Measured: pre treatment, follow up
Rosenberg Self-esteem scale
Measured: pre treatment, post treatment, follow up
Beck Depression Inventory (BDI-II)
Measured: pre treatment, post treatment, follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startJun 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Regina Steil, Goethe University
- Investigators
- Regina Steil, PhD, Principal investigator, Department of Clinical Psychology and Psychotherapy of the Johann Wolfgang Goethe University of Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976859
- Sponsor's protocol ID
- STUDIEBESCHMUTZTHEITI
- Status last verified
- May 2012
- First submitted
- 14 Sep 2009
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00976859
- Acronym / sponsor ID
- STUDIEBESCHMUTZTHEITI
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist control group | No intervention | Behavioral: Waitlist control group |
| Imagery Modification | Experimental | Behavioral: Imagery ModificationVia 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imagery ModificationAlso: Cognitive Restructuring and Imagery Modification; CRIMResearch 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 | Behavioural | Imagery Modification |
| Waitlist control groupPatients in the wait list control group are treated after a waiting period of five weeks | Behavioural | Waitlist control group |
Primary outcome
Intensity of the feeling of being contaminated (0-100: "not at all" till "extremely")
Time frame: 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
Distress associated to the feeling of being contaminated (0-100: "not at all" till "extremely")
Time frame: pre treatment, post treatment, follow up
4 secondary outcomes
Posttraumatic Diagnostic Scale
Time frame: pre treatment, post treatment, follow up
Clinician-administered PTSD Scale
Time frame: pre treatment, follow up
Rosenberg Self-esteem scale
Time frame: pre treatment, post treatment, follow up
Beck Depression Inventory (BDI-II)
Time frame: pre treatment, post treatment, follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regina Steil, PhD principal investigator
Department of Clinical Psychology and Psychotherapy of the Johann Wolfgang Goethe University of Frankfurt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imagery Modification in people with Sexual Abuse and Posttraumatic Stress Disorder, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of the feeling of being contaminated (0-100: "not at all" till "extremely") (time frame: pre treatment, post treatment, follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2012.