Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations

27 januari 2014 uppdaterad av: James S. Gordon, M.D., The Center for Mind-Body Medicine

A Randomized Controlled Study of Mind-Body Skills Groups for Treatment of War Zone Stress in Military and Veteran Populations

The purpose of this study is to determine whether participation in mind-body skills groups by veterans who have experienced a stressful war-related situation and have symptoms of posttraumatic stress disorder (PTSD), will improve symptoms of PTSD, depression and anxiety, reduce anger, improve quality of life, quality of sleep and result in posttraumatic growth (a positive change that people can experience when they have been in a traumatic situation).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

The study will be a randomized controlled study where participants will be randomly selected to either participate in the mind-body skills program and to answer questionnaires before and after the program and again 6 months later or, if they are not randomized to the mind-body skills group program, they will answer the questionnaires during the same time periods without participating in the program. Both groups will also continue their medical treatment as usual. The mind-body skills group intervention consists of groups of 8-10 participants. Two formats will be offered. (1) A 2 hour group session once a week for 10 weeks or (2) Weekend groups which will be run on alternating Saturdays, with a 2 hour session in the morning and another 2 hour session in the afternoon. The groups will be run for a total of 5 Saturday sessions. Additional "reunion" groups will be held at 1 month, 3 months, and 6 months in order to reinforce skills and to provide continuing social support.

Studietyp

Interventionell

Inskrivning (Faktisk)

108

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Louisiana
      • New Orleans, Louisiana, Förenta staterna, 70112
        • Southeast Louisiana Veterans Healthcare System

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • having experienced a deployment-related criterion A stressor and reporting post deployment stress symptoms which include: clinically diagnosed posttraumatic stress disorder (PTSD), or subthreshold PTSD symptoms
  • comorbid conditions may also include mild traumatic brain injury, or clinically significant levels of depression or anxiety.

Exclusion Criteria:

  • current uncontrolled psychotic or bipolar disorder
  • significant cognitive impairment
  • moderate or severe TBI
  • substance dependence
  • suicidal or homicidal ideation

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Standardbehandling
Övrig: Standard Treatment
May include individual or group psychotherapy consisting of cognitive behavioral therapy or present-centered (i.e. unrelated to mindfulness) psychotherapy as well as medication management. Medications for depression, anxiety, and sleep disorders are the most commonly used in standard treatment.
Experimentell: Mind-Body Skills Groups
Beteende: Mind-Body Skills Groups
The mind-body skills group program teaches participants how to do meditation, guided imagery, breathing techniques, and biofeedback. These mind-body techniques are taught and practiced in small groups of 8 to 10 people and also contain an element of social support.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
PTSD checklist - military version
Tidsram: Baseline; 12 weeks; 20 weeks
The PTSD checklist contains 17 items corresponding to the DSM-IV criteria for PTSD. Past month symptom severity is indicated using a 5 point scale.
Baseline; 12 weeks; 20 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
State-Trait Anger Expression Inventory-2
Tidsram: Baseline;12 weeks; 20 weeks
This is a 57 item consisting of a 4 point scale that measures the intensity of anger as an emotional state at a particular time (State Anger) and how often angry feelings are experienced over time as a personality trait (Trait Anger). There are 4 additional subscales which measure the outward expression of anger (Anger Expression-Out), holding or suppressing angry feelings (Anger Expression-In); controlling angry feelings by preventing the outward expression of anger (Anger Control-Out); and controlling anger feeling by calming down (Anger Control-In)
Baseline;12 weeks; 20 weeks
The Pittsburgh Sleep Quality Index
Tidsram: Baseline;12 weeks; 20 weeks
This 9 item questionnaire using a 4 point scale measures seven areas of sleep: subjective sleep quality, sleep latency, sleep duration, habitual seep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
Baseline;12 weeks; 20 weeks
The Patient Health Questionnaire-9
Tidsram: Baseline;12 weeks; 20 weeks
The Patient Health Questionnaire-9 is a 9 item self-report measure and is a widely used screening tool for depression.
Baseline;12 weeks; 20 weeks
State-Trait Anxiety Inventory
Tidsram: Baseline; 12 weeks; 20 weeks
The State anxiety subscale will be used. It has 20 questions and uses a 4 point scale.
Baseline; 12 weeks; 20 weeks
The Posttraumatic Growth Inventory
Tidsram: Baseline;12 weeks; 20 weeks
The Posttraumatic Growth Inventory measures positive change that people can experience when they have been in a traumatic situation. It is a 21 item self report scale that includes five subscales: relating to others, new possibilities, personal strength, spiritual challenge, and appreciation of life.
Baseline;12 weeks; 20 weeks
The Medical Outcomes Study Short Form SF-36
Tidsram: Baseline; 12 weeks; 20 weeks
The SF-36 has 36 questions and measures functional status in eight dimensions: physical functioning, social functioning, role functioning-physical, role functioning-emotional, vitality, mental health, bodily pain, and general health perception.
Baseline; 12 weeks; 20 weeks
The Inventory of Functional Impairment
Tidsram: Baseline;12 weeks; 20 weeks
The Inventory of Functional Impairment is an 87-item self-report measure designed to assess multiple dimensions of functional impairment experienced by active duty service members and veterans.
Baseline;12 weeks; 20 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The Center for Mind-Body Medicine

Samarbetspartners

U.S. Army Medical Research and Development Command
Southeast Louisiana Veterans Health Care System

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2010

Primärt slutförande (Faktisk)

1 september 2013

Avslutad studie (Faktisk)

1 september 2013

Studieregistreringsdatum

Först inskickad

24 mars 2010

Först inskickad som uppfyllde QC-kriterierna

24 mars 2010

Första postat (Uppskatta)

25 mars 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

29 januari 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 januari 2014

Senast verifierad

1 januari 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 08144040

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera