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Mental Health in Veterans and Families After Group Therapies

Primary Purpose

Post-Traumatic Stress Disorders

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
CBT (Cognitive Behavior Therapy)
EFT (Emotional Freedom Techniques)
Sponsored by
Soul Medicine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Post-Traumatic Stress Disorders

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Soul Medicine InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Active Comparator

Arm Label

Wait List

EFT (Emotional Freedom Techniques)

CBT (Cognitive Behavior Therapy)

Arm Description

Wait Period corresponding in length to treatment period

EFT group therapy sessions.

CBT group therapy sessions

Outcomes

Primary Outcome Measures

Change from Baseline PTSD (posttraumatic stress disorder) Symptom Levels
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.

Secondary Outcome Measures

Full Information

First Posted
January 4, 2011
Last Updated
April 11, 2023
Sponsor
Soul Medicine Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01327690
Brief Title
Mental Health in Veterans and Families After Group Therapies
Official Title
Mental Health in Veterans and Families After Group Therapies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soul Medicine Institute

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorders

7. Study Design

Primary Purpose
Screening
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wait List
Arm Type
No Intervention
Arm Description
Wait Period corresponding in length to treatment period
Arm Title
EFT (Emotional Freedom Techniques)
Arm Type
Experimental
Arm Description
EFT group therapy sessions.
Arm Title
CBT (Cognitive Behavior Therapy)
Arm Type
Active Comparator
Arm Description
CBT group therapy sessions
Intervention Type
Behavioral
Intervention Name(s)
CBT (Cognitive Behavior Therapy)
Intervention Description
CBT group therapy sessions
Intervention Type
Behavioral
Intervention Name(s)
EFT (Emotional Freedom Techniques)
Intervention Description
Group therapy sessions using EFT
Primary Outcome Measure Information:
Title
Change from Baseline PTSD (posttraumatic stress disorder) Symptom Levels
Description
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.
Time Frame
Pre-Intervention, Post-Intervention, with one, three, six, and twelve month follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dawson Church
Phone
707 237 6951
Email
dawsonchurch@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dawson Church
Phone
707 525 9292
Email
dawsonchurch@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawson Church, PhD
Organizational Affiliation
Soul Medicine Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soul Medicine Institute
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Cramer
Phone
707-237-6951
Email
chriscr@sonic.net

12. IPD Sharing Statement

Links:
URL
http://www.NIIH.org/
Description
Related Info

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Mental Health in Veterans and Families After Group Therapies

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