A Cognitive Behavioral Therapy and Yoga Program for Traum... | NCT02368444

Studies
A Cognitive Behavioral Therapy and Yoga Program for Trauma Symptoms

NCT02368444

Sponsor

Georgetown University

Status

Completed

Last Update Posted

Jun 7, 2022Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy and Yoga

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Feb 10, 2015

First Submission Date that Met QC Criteria

Feb 20, 2015

First Posted Date

Feb 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2022

Last Update Posted Date

Jun 7, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

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. The total length of the program will be 8 weeks. The sessions will be held 3 hours per week with 1.5 hours of group cognitive behavioral therapy and 1.5 hours of yoga. Changes in PTSD symptoms and sleep quality will be measured at baseline, immediately following the program, and at 2 month follow-up.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Group	Experimental	Cognitive Behavioral Therapy and Yoga	Behavioral: Cognitive Behavioral Therapy and Yoga

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive Behavioral Therapy and Yoga	Behavioral	Group Cognitive Behavioral Therapy Treatment and Yoga Program	Intervention Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Changes in Sleep Quality will be measured using the Pittsburgh Sleep Quality Index (PSQI)	Changes in Sleep Quality will be measured using the Pittsburgh Sleep Quality Index (PSQI)	Baseline and 8 weeks and 16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julie K Staples, Ph.D.	Georgetown University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yoga Studio		Albuquerque	New Mexico	87114	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015928	Cognitive Behavioral Therapy
D015013	Yoga

Ancestor Terms

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities
D026441	Mind-Body Therapies

Browse Leaves

Not provided

Browse Branches

Not provided