Evaluation of Telehealth Interventions for Post-Trauma Stress

NCT00350584 | Completed

• 2 other identifiers: Telehealth for PTSD SymptomsSIIB 1 EA-0000043
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Posttraumatic Stress Disorder (PTSD) is very prevalent within the veteran population and is associated with decreased quality of life and an increased risk of developing other psychiatric and physical illnesses. The overarching objective of the proposed study is to evaluate the effectiveness of two telehealth treatment conditions in promoting healing within a population of veterans with full or partial PTSD. In particular, we are targeting newly returned veterans from the Iraq and Afghanistan conflicts. Specifically, we are comparing the relative efficacy of an alternative therapeutic approach, a Mindfulness based treatment, with a Psychoeducation treatment in reducing symptoms of PTSD and more generalized psychiatric symptoms, while increasing quality of life. Of note, both treatment conditions will consist of two in-person sessions and six brief weekly telephone calls. Participants will be 58 veterans (29 per condition) recruited from the VA Boston Healthcare System. Assessment will occur before and after the delivery of the intervention. We hypothesize that while both treatments will result in improved outcomes, the Mindfulness intervention will promote more healing than the Psychoeducation intervention. Results from this project will help further our understanding of the role of mindfulness in treating PTSD, particularly in those veterans who are returning from deployment.

Conditions

Post Traumatic Stress Disorders

Keywords

Mindfulness; Psychoeducation; Telehealth Intervention

Outcome Measures

Primary Outcomes (1)

• Clinician Administered PTSD Scale (CAPS)

  Gold standard instrument to assess symptoms of PTSD. Administered by a clinician.

  pre and post intervention

Secondary Outcomes (1)

• PTSD Checklist

  pre and post intervention

Study Arms (2)

Mindfulness Telehealth for PTSD

EXPERIMENTAL

Participants receive two in-person sessions and 6 sessions over the phone. Participants are introduced to mindfulness concepts. CDs with guided meditation exercises are given to participants and they are asked to practice between sessions.

Behavioral: Mindfulness Telehealth Intervention

Psychoeducation Telehealth for PTSD

ACTIVE COMPARATOR

Participants receive two in-person sessions and six telehealth sessions with education about symptoms of PTSD and coping strategies. In addition, participants are asked to read short homework assignments and think about them during the week; these are discussed in weekly sessions.

Behavioral: Psychoeducation Telehealth Intervention

Interventions

Mindfulness Telehealth Intervention BEHAVIORAL

Two in-person sessions and six telephone sessions with a therapist. Focus is on learning mindfulness skills.

Mindfulness Telehealth for PTSD

Psychoeducation Telehealth Intervention BEHAVIORAL

Two in-person sessions and six telephone sessions with a therapist. Focus is on education about PTSD.

Psychoeducation Telehealth for PTSD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• documented United States military service in war or peacekeeping theater
• a current diagnosis of PTSD or partial PTSD
• access to a telephone

You may not qualify if:

• veteran's mental status precludes completion of the assessment procedures (e.g., severe organicity or active psychosis)
• the veteran's regimen of psychiatric medication has not been stable over the past two months (if applicable)
• the veteran has symptoms consistent with a diagnosis of alcohol or drug dependence within the past three months.

Sponsors & Collaborators

• VA Boston Healthcare System: lead
• Samueli Institute for Information Biology: collaborator

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Barbara L Niles, Ph.D.

  VA Boston Healthcare System

  PRINCIPAL INVESTIGATOR

• Amy K Silberbogen, Ph.D.

  VA Boston Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: July 10, 2006
• First Posted: July 11, 2006
• Study Start: February 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: July 29, 2011

Record last verified: 2009-01

Locations

US (1)