Evaluation of Telehealth Interventions for Post-Trauma Stress

Post Traumatic Stress Disorders Clinical Trial

Official title:

Evaluation of Two Telehealth Interventions Targeting Post-Trauma Stress in Combat Veterans: Comparing Mindfulness and Psychoeducation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350584
• Other study ID #: Telehealth for PTSD Symptoms
• Secondary ID: SIIB 1 EA-000004
• Status: Completed
• Phase: N/A
• First received: July 10, 2006
• Last updated: July 28, 2011
• Start date: February 2007
• Est. completion date: April 2008

Study information

• Verified date: January 2009
• Source: VA Boston Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

Aim: To evaluate the relative feasibility and healing efficacy of two eight-week telehealth interventions for individuals with combat-related PTSD: (1) Mindfulness and (2) Psychoeducation.

Objectives:

1. The first short-term objective is to determine whether two eight-week telehealth interventions are:

1. feasible to conduct in a population of veterans with symptoms of combat-related PTSD;

2. effective at promoting healing specific to combat survivors as evidenced by reductions in symptoms of PTSD;

3. effective at promoting more generalized healing in combat veterans as evidenced by reductions in symptoms that are often co-morbid with PTSD (e.g., depression, anxiety, and substance abuse problem severity); and

4. effective at promoting healing beyond a symptom level in combat veterans as evidenced by increases in quality of life after the interventions.

2. The second short-term objective of this study is to determine whether a Mindfulness intervention will be more effective at promoting healing than a Psychoeducation intervention. This comparison will be made on the levels of specific PTSD symptoms, more general co-morbid symptoms, and global quality of life.

3. The long-term objectives of this line of research are to identify mechanisms of action in a Mindfulness Telehealth Intervention that allow healing and promote increased quality of life in individuals with PTSD.

4. An additional long-term objective of this project is to contribute to the development of efficacious wellness interventions that can promote healing after combat exposure in veterans returning from current military conflicts (e.g. Iraq and Afghanistan).

Hypotheses:

1. It is hypothesized that both eight-week telehealth interventions (Mindfulness and Psychoeducation) will be feasible in a population of veterans with symptoms of combat-related PTSD. Specifically, satisfaction and compliance with the interventions is predicted to be high.

2. It is hypothesized that both eight-week telehealth interventions (Mindfulness and Psychoeducation) will be effective at promoting healing and reducing symptoms of PTSD. Specifically, it is predicted that levels of PTSD measured post-intervention will be lower than levels measured pre-intervention.

3. It is hypothesized that both eight-week telehealth interventions (Mindfulness and Psychoeducation) will be effective at promoting healing and reducing symptoms co-morbid with PTSD. Specifically, it is predicted that levels of depression, anxiety, and substance abuse problem severity measured post-intervention will be lower than levels measured pre-intervention.

4. It is hypothesized that both eight-week telehealth interventions (Mindfulness and Psychoeducation) will be effective at improving quality of life. Specifically, it is predicted that levels of quality of life measured post-intervention will be higher than levels measured pre-intervention.

5. Although it is hypothesized that both eight-week interventions will be effective at healing for veterans with PTSD symptoms, the holistic Mindfulness intervention is hypothesized to be more effective at promoting healing and reducing symptoms of PTSD and co-morbid disorders and improving quality of life than the Psychoeducation intervention. Specifically, it is predicted that levels of PTSD, depression, anxiety, and substance abuse problem severity will be lower post-intervention and quality of life will be higher for those individuals in the Mindfulness condition than for those in the Psychoeducation condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• documented United States military service in war or peacekeeping theater

• a current diagnosis of PTSD or partial PTSD

• access to a telephone

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post Traumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Mindfulness Telehealth Intervention
Two in-person sessions and six telephone sessions with a therapist. Focus is on learning mindfulness skills.
• Psychoeducation Telehealth Intervention
Two in-person sessions and six telephone sessions with a therapist. Focus is on education about PTSD.

Locations

Country	Name	City	State
United States	VA Boston Healthcare System	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
VA Boston Healthcare System	Samueli Institute for Information Biology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale (CAPS)	Gold standard instrument to assess symptoms of PTSD. Administered by a clinician.	pre and post intervention	No
Secondary	PTSD Checklist	Self-report instrument to assess symptoms of PTSD.	pre and post intervention	No