- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00350584
Evaluation of Telehealth Interventions for Post-Trauma Stress
28 lipca 2011 zaktualizowane przez: VA Boston Healthcare System
Evaluation of Two Telehealth Interventions Targeting Post-Trauma Stress in Combat Veterans: Comparing Mindfulness and Psychoeducation
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.
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
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:
The first short-term objective is to determine whether two eight-week telehealth interventions are:
- feasible to conduct in a population of veterans with symptoms of combat-related PTSD;
- effective at promoting healing specific to combat survivors as evidenced by reductions in symptoms of PTSD;
- 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
- effective at promoting healing beyond a symptom level in combat veterans as evidenced by increases in quality of life after the interventions.
- 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.
- 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.
- 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:
- 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.
- 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.
- 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.
- 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.
- 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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
33
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02130
- VA Boston Healthcare System
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Mindfulness Telehealth for PTSD
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.
|
Two in-person sessions and six telephone sessions with a therapist.
Focus is on learning mindfulness skills.
|
|
Aktywny komparator: Psychoeducation Telehealth for PTSD
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.
|
Two in-person sessions and six telephone sessions with a therapist.
Focus is on education about PTSD.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Clinician Administered PTSD Scale (CAPS)
Ramy czasowe: pre and post intervention
|
Gold standard instrument to assess symptoms of PTSD.
Administered by a clinician.
|
pre and post intervention
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
PTSD Checklist
Ramy czasowe: pre and post intervention
|
Self-report instrument to assess symptoms of PTSD.
|
pre and post intervention
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Barbara L Niles, Ph.D., VA Boston Healthcare System
- Główny śledczy: Amy K Silberbogen, Ph.D., VA Boston Healthcare System
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 lutego 2007
Zakończenie podstawowe (Rzeczywisty)
1 kwietnia 2008
Ukończenie studiów (Rzeczywisty)
1 kwietnia 2008
Daty rejestracji na studia
Pierwszy przesłany
10 lipca 2006
Pierwszy przesłany, który spełnia kryteria kontroli jakości
10 lipca 2006
Pierwszy wysłany (Oszacować)
11 lipca 2006
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
29 lipca 2011
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
28 lipca 2011
Ostatnia weryfikacja
1 stycznia 2009
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Telehealth for PTSD Symptoms
- SIIB 1 EA-0000043
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .