Child Abuse, SexualPhase 2NCT00097305
Body-Oriented Therapy for Sexual Abuse Recovery
A Phase 2 study testing Body-Oriented Therapy and Standardized Massage Therapy in people with Child Abuse, Sexual and Post-Traumatic Stress Disorder, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to examine and compare the effects of two body therapy approaches in women who have experienced child sexual abuse. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Child Abuse, Sexual, Post-Traumatic Stress Disorder, Dissociation
- What is being tested?
- Body-Oriented Therapy and Standardized Massage Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to not given
- Phase
- Phase 2
- 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported child sexual abuse
- In current psychotherapy for child sexual abuse recovery
Who cannot join
- Over 6 months of past experience with body-oriented therapy
- Diagnosis or medications for psychosis
- Drug or alcohol addiction
- Current abusive relationship
- Dissociative disorder
- In transition on psychotropic medication
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington School of Nursing
Seattle, Washington, 98195
About this study
Official title: Delving Intervention and Mindbody Integration
The purpose of this study is to examine and compare the effects of two body therapy approaches in women who have experienced child sexual abuse.
Read the detailed description
Women who have experienced child sexual abuse often display symptoms of dissociation and lack of bodily self-awareness which hinder the recovery process. Mind-body researchers have examined alternative therapeutic approaches to eliminating these factors. This study will compare a standardized therapeutic message to body-oriented therapy which involves a combination of hands-on bodywork and verbal therapy focused on somatic and emotional awareness.
- Being tested
- Body-Oriented Therapy, Standardized Massage Therapy
- Keywords
- Mental Health, Psychotherapy
- Medical subject headings
- Coitus, Stress Disorders, Post-Traumatic, Dissociative Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body-Oriented TherapyBehavioural
Standardized Massage TherapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2004 (estimated)
- Study startSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child Abuse, SexualStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Cynthia Price, PhD, Principal investigator, Assistant Professor, University of Washington School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097305
- Sponsor's protocol ID
- F31AT001053
- Status last verified
- Aug 2006
- First submitted
- 19 Nov 2004
- Last updated
- 11 Sep 2007
- Results posted
- No
Publications
Price, C. Characteristics of women seeking bodywork as an adjunct to psychotherapy during recovery from childhood sexual abuse. Journal of Bodywork and Movement Therapies, 8(1): 35-42, 2004.
Price, C. Body-oriented therapy as an adjunct to psychotherapy in recovery from childhood abuse: A case study. Journal of Bodywork and Movement Therapies, 6(4): 228-236, 2002.
Price C. Bodywork for childhood abuse treatment: a pilot-test comparison. 35th Annual Communicating Nursing Research Conference/16th Annual WIN Assembly, Health Disparities: Meeting the Challenge, April 18-20, 2002, Palm Springs, California. Communicating Nursing Research. 35(10):264, 2002.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delving Intervention and Mindbody Integration
- ClinicalTrials.gov ID
- NCT00097305
- Acronym / sponsor ID
- F31AT001053
- Keywords
- Mental Health, Psychotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Sep 2002
- First posted
- 22 Nov 2004 (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 examine and compare the effects of two body therapy approaches in women who have experienced child sexual abuse.
Detailed description
Women who have experienced child sexual abuse often display symptoms of dissociation and lack of bodily self-awareness which hinder the recovery process. Mind-body researchers have examined alternative therapeutic approaches to eliminating these factors. This study will compare a standardized therapeutic message to body-oriented therapy which involves a combination of hands-on bodywork and verbal therapy focused on somatic and emotional awareness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Self-reported child sexual abuse
- In current psychotherapy for child sexual abuse recovery
Key exclusion criteria (6 listed)
- Over 6 months of past experience with body-oriented therapy
- Diagnosis or medications for psychosis
- Drug or alcohol addiction
- Current abusive relationship
- Dissociative disorder
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 |
|---|---|---|
| Body-Oriented Therapy | Behavioural | – |
| Standardized Massage Therapy | Behavioural | – |
Primary outcome
Not reported in the source record.
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 11 Sep 2007.
- BackgroundPrice, C. Characteristics of women seeking bodywork as an adjunct to psychotherapy during recovery from childhood sexual abuse. Journal of Bodywork and Movement Therapies, 8(1): 35-42, 2004.
- BackgroundPrice, C. Body-oriented therapy as an adjunct to psychotherapy in recovery from childhood abuse: A case study. Journal of Bodywork and Movement Therapies, 6(4): 228-236, 2002.
- BackgroundPrice C. Bodywork for childhood abuse treatment: a pilot-test comparison. 35th Annual Communicating Nursing Research Conference/16th Annual WIN Assembly, Health Disparities: Meeting the Challenge, April 18-20, 2002, Palm Springs, California. Communicating Nursing Research. 35(10):264, 2002.
Related trials for Child Abuse, Sexual
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Rigorous Evaluation of the READY to Stand Curriculum to Prevent the Commercial Sexual Exploitation of Children
Sex Trafficking, Sex Crimes
Active, not recruiting
Implementation Study With Embedded RCT of a Digital System of Parenting Support Within Government Services in South Africa
Program Effectiveness, Program Implementation
RecruitingObservational study
Young Girls' Experiences of Exposure to Pornography: A Qualitative Study
Exposure to Pornography
Recruiting
A Group Based Psychoeducational Intervention for Partners of Child Sexual Abuse Material Offenders.
Partner
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.
Cynthia Price, PhD principal investigator
Assistant Professor, University of Washington School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Body-Oriented Therapy and Standardized Massage Therapy in people with Child Abuse, Sexual and Post-Traumatic Stress Disorder, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
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 2 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 11 Sep 2007. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00097305, which also lists 3 linked publications.
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 11 Sep 2007.