- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00350584
Evaluation of Telehealth Interventions for Post-Trauma Stress
28 luglio 2011 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
33
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02130
- VA Boston Healthcare System
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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Two in-person sessions and six telephone sessions with a therapist.
Focus is on learning mindfulness skills.
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Comparatore attivo: 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.
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Two in-person sessions and six telephone sessions with a therapist.
Focus is on education about PTSD.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Clinician Administered PTSD Scale (CAPS)
Lasso di tempo: pre and post intervention
|
Gold standard instrument to assess symptoms of PTSD.
Administered by a clinician.
|
pre and post intervention
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
PTSD Checklist
Lasso di tempo: pre and post intervention
|
Self-report instrument to assess symptoms of PTSD.
|
pre and post intervention
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Barbara L Niles, Ph.D., VA Boston Healthcare System
- Investigatore principale: Amy K Silberbogen, Ph.D., VA Boston Healthcare System
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 febbraio 2007
Completamento primario (Effettivo)
1 aprile 2008
Completamento dello studio (Effettivo)
1 aprile 2008
Date di iscrizione allo studio
Primo inviato
10 luglio 2006
Primo inviato che soddisfa i criteri di controllo qualità
10 luglio 2006
Primo Inserito (Stima)
11 luglio 2006
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
29 luglio 2011
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 luglio 2011
Ultimo verificato
1 gennaio 2009
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Telehealth for PTSD Symptoms
- SIIB 1 EA-0000043
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .