Stress Disorders, Post-TraumaticNCT00055354
Acupuncture for the Treatment of Post-Traumatic Stress Disorder (PTSD)
A study testing Acupuncture and Cognitive Behavioral Therapy in people with Stress Disorders, Post-Traumatic, 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 evaluate acupuncture as a treatment for Post-Traumatic Stress Disorder (PTSD) and to correlate the diagnosis of PTSD with Traditional Chinese Medicine (TCM) diagnostic patterns. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Acupuncture and Cognitive Behavioral Therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to May 2004
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV diagnosis of PTSD
- Stage I PTSD symptoms
- PTSD Symptom Scale-Self Report (PSS-SR) score > 16
- Meets PSS-SR diagnostic criteria
Who cannot join
- Stage I substance abuse and/or dependence in the past 6 months
- Psychotic disorder
- Inability to commit to treatment or wait-list conditions
- Current treatment specifically for PTSD
- Certain medical conditions, including thyroid disease, class IV heart failure, active cancer treatment, and uncontrolled diabetes
- Pregnant
- Use of benzodiazepines, narcotics, opiates, narcotic antagonists, sleep medication, muscle relaxants, analgesics, or sedatives.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Health Sciences Center- Department of Psychiatry
Albuquerque, New Mexico, 87131
About this study
Official title: Acupuncture Diagnosis and Treatment of DSM-IV PTSD
The purpose of this study is to evaluate acupuncture as a treatment for Post-Traumatic Stress Disorder (PTSD) and to correlate the diagnosis of PTSD with Traditional Chinese Medicine (TCM) diagnostic patterns.
Read the detailed description
This study will evaluate: 1) the TCM diagnostic differentiation patterns of people who have PTSD as defined by the Diagnostic and Statistical Manual, 4th edition; 2) if an acupuncture treatment approach is acceptable to people with PTSD; and 3) if an acupuncture treatment approach is associated with a reduction in PTSD symptoms that is comparable to that of standard treatments. Because symptoms of depression, insomnia, and pain are often associated with PTSD, we will also evaluate the potential benefit of an acupuncture approach to depression, insomnia, and pain symptoms in people with PTSD.
Patients in this study will be randomized to one of three groups. Group A will receive acupuncture therapy. Group B will receive standard Cognitive Behavior Therapy. Group C is a control group and will receive no treatment. Patients in Groups A and B will undergo a total of 24 hours of therapy over the 3 month study course. All patients will have five nontherapeutic study visits; these visits will address diagnosis and assessment. Study visits will include assessments of PTSD symptoms, sleep symptoms, and level of impairment.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Acupuncture, Cognitive Behavioral Therapy
- Keywords
- Acupuncture, Medicine, Chinese Traditional
- 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.
AcupunctureProcedure or surgery
Cognitive Behavioral TherapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2003 (estimated)
- Study startSep 2002
- Study completionMay 2004
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055354
- Sponsor's protocol ID
- R21AT001229-01
- Status last verified
- Jul 2006
- First submitted
- 26 Feb 2003
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Diagnosis and Treatment of DSM-IV PTSD
- ClinicalTrials.gov ID
- NCT00055354
- Acronym / sponsor ID
- R21AT001229-01
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Acupuncture, Medicine, Chinese Traditional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Sep 2002
- Study completion
- May 2004
- First posted
- 27 Feb 2003 (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 evaluate acupuncture as a treatment for Post-Traumatic Stress Disorder (PTSD) and to correlate the diagnosis of PTSD with Traditional Chinese Medicine (TCM) diagnostic patterns.
Detailed description
This study will evaluate: 1) the TCM diagnostic differentiation patterns of people who have PTSD as defined by the Diagnostic and Statistical Manual, 4th edition; 2) if an acupuncture treatment approach is acceptable to people with PTSD; and 3) if an acupuncture treatment approach is associated with a reduction in PTSD symptoms that is comparable to that of standard treatments. Because symptoms of depression, insomnia, and pain are often associated with PTSD, we will also evaluate the potential benefit of an acupuncture approach to depression, insomnia, and pain symptoms in people with PTSD.
Patients in this study will be randomized to one of three groups. Group A will receive acupuncture therapy. Group B will receive standard Cognitive Behavior Therapy. Group C is a control group and will receive no treatment. Patients in Groups A and B will undergo a total of 24 hours of therapy over the 3 month study course. All patients will have five nontherapeutic study visits; these visits will address diagnosis and assessment. Study visits will include assessments of PTSD symptoms, sleep symptoms, and level of impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- DSM-IV diagnosis of PTSD
- Stage I PTSD symptoms
- PTSD Symptom Scale-Self Report (PSS-SR) score > 16
- Meets PSS-SR diagnostic criteria
Key exclusion criteria (7 listed)
- Stage I substance abuse and/or dependence in the past 6 months
- Psychotic disorder
- Inability to commit to treatment or wait-list conditions
- Current treatment specifically for PTSD
- Certain medical conditions, including thyroid disease, class IV heart failure, active cancer treatment, and uncontrolled diabetes
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 |
|---|---|---|
| Acupuncture | Procedure or surgery | – |
| Cognitive Behavioral 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 18 Aug 2006.
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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 Acupuncture and Cognitive Behavioral Therapy in people with Stress Disorders, Post-Traumatic, 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 4 inclusion and 7 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 18 Aug 2006. 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 18 Aug 2006.