Stress Disorders, Post-TraumaticNCT00047684
Brief Integrative Therapy for Post-Traumatic Stress Disorder
A study testing Brief Integrative Therapy in people with Stress Disorders, Post-Traumatic, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to refine Brief Integrative Therapy (BIT) and to evaluate its effectiveness in treating women with Post-Traumatic Stress Disorder (PTSD) following childhood sexual abuse. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Brief Integrative Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Nov 2002
- 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
- Post-Traumatic Stress Disorder (PTSD) diagnosis
- Childhood sexual abuse, defined as any sexual contact before the age of 16 with someone 5 or more years older
- At least 1 clear, detailed memory of sexual abuse
Who cannot join
- Substance abuse or dependence
- Psychotic disorder, bipolar disorder, or dissociative disorder
- 2 or more suicidal or parasuicidal acts in the past year
- Domestic violence involvement
- Pregnancy or attempting to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
National Center for PTSD
White River Junction, Vermont, 05001
About this study
Official title: Development and Initial Evaluation of Brief Integrative Therapy for PTSD
The purpose of this study is to refine Brief Integrative Therapy (BIT) and to evaluate its effectiveness in treating women with Post-Traumatic Stress Disorder (PTSD) following childhood sexual abuse. This study will also promote the development of skills that are necessary for increasing quality of life and improving self-esteem.
Read the detailed description
BIT integrates interpersonal, problem solving, affect regulation, and psychoeducational components. In this study, BIT is used to encourage women to focus on current issues and problems. The BIT therapist will help patients identify the impact of PTSD on their functioning, help them identify effective coping strategies for dealing with trauma-related distress, and encourage them to establish and maintain a certain degree of independence from the therapist.
Patients receive 15 weekly sessions of BIT. Assessments occur pre-treatment, post-treatment, and at a 3-month follow-up, and include self-report measures, clinician administered PTSD scale questions, interviews, and evaluations of lifetime stressors.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Brief Integrative Therapy
- Keywords
- Child Abuse, Sexual
- Medical subject headings
- Stress Disorders, Post-Traumatic, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Integrative TherapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2002 (estimated)
- Study startNov 2001
- Study completionNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047684
- Sponsor's protocol ID
- R21MH061319
- Other IDs
- R21MH061319, DSIR AT-AS
- Status last verified
- Sep 2008
- First submitted
- 11 Oct 2002
- Last updated
- 10 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Initial Evaluation of Brief Integrative Therapy for PTSD
- ClinicalTrials.gov ID
- NCT00047684
- Acronym / sponsor ID
- R21MH061319
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Child Abuse, Sexual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2001
- Study completion
- Nov 2002
- First posted
- 16 Oct 2002 (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 refine Brief Integrative Therapy (BIT) and to evaluate its effectiveness in treating women with Post-Traumatic Stress Disorder (PTSD) following childhood sexual abuse. This study will also promote the development of skills that are necessary for increasing quality of life and improving self-esteem.
Detailed description
BIT integrates interpersonal, problem solving, affect regulation, and psychoeducational components. In this study, BIT is used to encourage women to focus on current issues and problems. The BIT therapist will help patients identify the impact of PTSD on their functioning, help them identify effective coping strategies for dealing with trauma-related distress, and encourage them to establish and maintain a certain degree of independence from the therapist.
Patients receive 15 weekly sessions of BIT. Assessments occur pre-treatment, post-treatment, and at a 3-month follow-up, and include self-report measures, clinician administered PTSD scale questions, interviews, and evaluations of lifetime stressors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Post-Traumatic Stress Disorder (PTSD) diagnosis
- Childhood sexual abuse, defined as any sexual contact before the age of 16 with someone 5 or more years older
- At least 1 clear, detailed memory of sexual abuse
Key exclusion criteria (5 listed)
- Substance abuse or dependence
- Psychotic disorder, bipolar disorder, or dissociative disorder
- 2 or more suicidal or parasuicidal acts in the past year
- Domestic violence involvement
- Pregnancy or attempting to become pregnant
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 |
|---|---|---|
| Brief Integrative 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 10 Sep 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Integrative Therapy in people with Stress Disorders, Post-Traumatic, run by Dartmouth-Hitchcock Medical Center 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 3 inclusion and 5 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 10 Sep 2013. 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.
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?
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 10 Sep 2013; AzTrials last refreshed its copy on 31 Oct 2026.