Mental Health in Veterans and Families After Group Therapies

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Soul Medicine Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Soul Medicine Institute
ClinicalTrials.gov Identifier:
NCT01327690
First received: January 4, 2011
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Post-Traumatic Stress Disorders
Behavioral: CBT (Cognitive Behavior Therapy)
Behavioral: EFT (Emotional Freedom Techniques)
Behavioral: Wait List
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Mental Health in Veterans and Families After Group Therapies

Resource links provided by NLM:


Further study details as provided by Soul Medicine Institute:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Wait List
Wait Period corresponding in length to treatment period
Behavioral: Wait List
Wait period corresponding in duration to treatment period in active and experimental groups.
Experimental: EFT (Emotional Freedom Techniques)
EFT group therapy sessions.
Behavioral: EFT (Emotional Freedom Techniques)
Group therapy sessions using EFT
Active Comparator: CBT (Cognitive Behavior Therapy)
CBT group therapy sessions
Behavioral: CBT (Cognitive Behavior Therapy)
CBT group therapy sessions

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The ability to follow instructions, complete written forms, and provide informed consent. Subjects are required to be literate and understand English.
  • Physically healthy.
  • Active duty military service, veterans, and their family members.

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327690

Contacts
Contact: Deb Tribbey 707 237 6951 deb@soulmedicine.net
Contact: Will McCurry 707 525 9292 will.mccurry@gmail.com

Locations
United States, California
Soul Medicine Institute Recruiting
Santa Rosa, California, United States, 95404
Contact: Deburah Tribbey    707-237-6951    deb@soulmedicine.net   
Sponsors and Collaborators
Soul Medicine Institute
Investigators
Principal Investigator: Dawson Church, PhD Soul Medicine Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Dawson Church, PhD, Soul Medicine Institute
ClinicalTrials.gov Identifier: NCT01327690     History of Changes
Other Study ID Numbers: SMI-GROUP-12/10/10
Study First Received: January 4, 2011
Last Updated: March 31, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014