Mental Health in Veterans and Families After Group Therapies

• Sponsor: Soul Medicine Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01327690
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 3
• Duration (Months): 180
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Traumatic Stress Disorders	Behavioral: CBT (Cognitive Behavior Therapy); Behavioral: EFT (Emotional Freedom Techniques)	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Screening
• Official Title: Mental Health in Veterans and Families After Group Therapies
• Study Start Date: Dec 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Wait List Wait Period corresponding in length to treatment period
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

Outcome Measures

Primary Outcome Measures

1. Change from Baseline PTSD (posttraumatic stress disorder) Symptom Levels [Pre-Intervention, Post-Intervention, with one, three, six, and twelve month follow-ups]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Soul Medicine Institute	Santa Rosa	California	United States	95404

Sponsors and Collaborators

• Soul Medicine Institute

Investigators

• Principal Investigator: Dawson Church, PhD, Soul Medicine Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Dawson Church, Principal Investigator, Soul Medicine Institute
• ClinicalTrials.gov Identifier: NCT01327690
• Other Study ID Numbers: SMI-GROUP-12/10/10
• First Posted: Apr 1, 2011
• Last Update Posted: Apr 6, 2022
• Last Verified: Apr 1, 2022

• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Apr 6, 2022