NCT00976859

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

May 16, 2012

Status Verified

May 1, 2012

Enrollment Period

1.3 years

First QC Date

September 14, 2009

Last Update Submit

May 15, 2012

Conditions

Sexual AbusePosttraumatic Stress Disorder

Keywords

childhood sexual abuseCSAposttraumatic stress disorderPTSD, feeling of being pollutedmental pollution, mental contaminationfeeling of being contaminatedsexual assaultdisgust, shame

Outcome Measures

Primary Outcomes (3)

  • Intensity of the feeling of being contaminated (0-100: "not at all" till "extremely")

    pre treatment, post treatment, follow up

  • Vividness of the feeling of being contaminated (0-100: "not at all" till "extremely")

    pre treatment, post treatment, follow up

  • Distress associated to the feeling of being contaminated (0-100: "not at all" till "extremely")

    pre treatment, post treatment, follow up

Secondary Outcomes (4)

  • Posttraumatic Diagnostic Scale

    pre treatment, post treatment, follow up

  • Clinician-administered PTSD Scale

    pre treatment, follow up

  • Rosenberg Self-esteem scale

    pre treatment, post treatment, follow up

  • Beck Depression Inventory (BDI-II)

    pre treatment, post treatment, follow up

Study Arms (2)

Waitlist control group

NO INTERVENTION
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

Behavioral: Imagery Modification

Interventions

Imagery ModificationBEHAVIORAL

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

Also known as: Cognitive Restructuring and Imagery Modification; CRIM
Imagery Modification
Waitlist control groupBEHAVIORAL

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

Waitlist control group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Psychology and Psychotherapy of the Johann Wolfgang Goethe University

Frankfurt am Main, Hesse, D-60054, Germany

Location

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cognitive Restructuring

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Regina Steil, PhD

    Department of Clinical Psychology and Psychotherapy of the Johann Wolfgang Goethe University of Frankfurt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 14, 2009

First Posted

September 15, 2009

Study Start

June 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

May 16, 2012

Record last verified: 2012-05

Locations

DE(1)