Exposure Therapy for Veterans With PTSD and Panic Attacks (Phase 1)

NCT01551199 | Completed Phase 1 Results DMC

• 1 other identifier: CDA2-012-09F-1
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the feasibility, acceptability and effectiveness of Multiple Channel Exposure Therapy-Veterans (MCET-V) as a treatment for returning service members with comorbid posttraumatic stress disorder (PTSD) and panic disorder (PD) in two phases. The first phase of the study will examine the feasibility and acceptability of MCET-V.

Conditions

PTSD; Panic Attacks

Outcome Measures

Primary Outcomes (2)

• Clinician Administered PTSD Scale (CAPS)

  The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (daily/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.

  1-week post-treatment (approximately week 14)

• Clinician Administered PTSD Scale (CAPS)

  The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (daily/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.

  3-month follow-up (approximately week 26)

Secondary Outcomes (1)

• Anxiety Disorders Interview Schedule- DSM-IV (ADIS-IV)

  3 Months

Study Arms (1)

Multiple Channel Exposure Therapy

EXPERIMENTAL

MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks

Behavioral: Multiple Channel Exposure Therapy- Veterans

Interventions

Multiple Channel Exposure Therapy- Veterans BEHAVIORAL

Individual therapy design completed over a 12-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises.

Also known as: MCET-V

Multiple Channel Exposure Therapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• being a veteran of any era;
• being enrolled in the Trauma Recovery Program (TRP) at the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC), with a current diagnosis of PTSD and PD;
• being stable on psychotropic medication for 4 weeks before study participation; and
• being at least 18 years of age.

You may not qualify if:

• active substance dependence, or bipolar or psychotic disorders;
• severe depression and active suicidal ideation and intent (based on Structured Clinical Interview for DSM-IV disorders \[SCID-IV\] \& Beck Depression Inventory-2nd edition \[BDI-II\]);
• cognitive impairment as indicated by the St. Louis University Mental Status exam (SLUMS); and
• veterans currently receiving psychosocial treatment specifically targeting PTSD or panic symptoms.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Panic Disorder

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Anxiety Disorders

Results Point of Contact

• Title: Dr. Ellen Teng
• Organization: Michael E. DeBakey VA Medical Center

ellen.teng@va.gov

(713) 791-1414

Study Officials

• Ellen Teng, PhD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 12, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 23, 2017
• Results First Posted: January 13, 2015

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)