Mental Health in Veterans and Families After Group Therapies
This study is currently recruiting participants.
Verified March 2011 by Soul Medicine Institute
Sponsor:
Soul Medicine Institute
Information provided by:
Soul Medicine Institute
ClinicalTrials.gov Identifier:
NCT01327690
First received: January 4, 2011
Last updated: March 31, 2011
Last verified: March 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 4, 2011 | ||||||||
| Last Updated Date | March 31, 2011 | ||||||||
| Start Date ICMJE | December 2010 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change from Baseline PTSD (posttraumatic stress disorder) Symptom Levels [ Time Frame: Pre-Intervention, Post-Intervention, with one, three, six, and twelve month follow-ups ] [ Designated as safety issue: No ] Symptoms are measured before the first group therapy session. Symptom levels are also recorded immediately after the last group session, and at follow-up points: one, three, six, and twelve months later. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01327690 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Mental Health in Veterans and Families After Group Therapies | ||||||||
| Official Title ICMJE | Mental Health in Veterans and Families After Group Therapies | ||||||||
| Brief Summary | PTSD (posttraumatic stress disorder) and associated mental health conditions affect both veterans and their family members. This study investigates whether group therapy using EFT (Emotional Freedom Techniques) and CBT (Cognitive Behavior Therapy) produce reductions in PTSD and comorbid symptoms. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 0 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Screening |
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| Condition ICMJE | Post-Traumatic Stress Disorders | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01327690 | ||||||||
| Other Study ID Numbers ICMJE | SMI-GROUP-12/10/10 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Dawson Church, PhD, Soul Medicine Institute | ||||||||
| Study Sponsor ICMJE | Soul Medicine Institute | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Soul Medicine Institute | ||||||||
| Verification Date | March 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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