NCT02368444

Brief Summary

The purpose of the proposed study is to evaluate the effectiveness of a cognitive behavioral therapy (CBT) and yoga program for improving posttraumatic stress disorder (PTSD) symptoms and sleep quality in people who have experienced a traumatic event and are reporting trauma symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

1.7 years

First QC Date

February 10, 2015

Last Update Submit

June 5, 2022

Conditions

Stress Disorders, Post-Traumatic

Keywords

Posttraumatic StressSleep

Outcome Measures

Primary Outcomes (1)

  • Changes in Posttraumatic Stress Symptoms will be measured using the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) (PCL-5)

    Changes in Posttraumatic Stress Symptoms will be measured using the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) (PCL-5)

    Baseline and 8 weeks and 16 weeks

Secondary Outcomes (1)

  • Changes in Sleep Quality will be measured using the Pittsburgh Sleep Quality Index (PSQI)

    Baseline and 8 weeks and 16 weeks

Study Arms (1)

Intervention Group

EXPERIMENTAL

Cognitive Behavioral Therapy and Yoga

Behavioral: Cognitive Behavioral Therapy and Yoga

Interventions

Cognitive Behavioral Therapy and YogaBEHAVIORAL

Group Cognitive Behavioral Therapy Treatment and Yoga Program

Also known as: T.E.A.M. Cognitive Behavioral Therapy, Kundalini Yoga
Intervention Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinically diagnosed posttraumatic stress disorder (PTSD) or subthreshold PTSD symptoms

You may not qualify if:

  • current uncontrolled psychotic or bipolar disorder, significant cognitive impairment, substance dependence, non-English speaking, or a significant medical condition that would interfere with participation in the yoga portion of the program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yoga Studio

Albuquerque, New Mexico, 87114, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral TherapyYoga

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesMind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Julie K Staples, Ph.D.

    Georgetown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Adjunct Professor

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 23, 2015

Study Start

May 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

June 7, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)