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Online and Mobile Mindfulness Intervention to Reduce Distress

16. August 2019 aktualisiert von: Jason Owen, VA Palo Alto Health Care System
The purpose of this study is to test whether a mobile app can improve mindful awareness, attention, and psychological well-being in Veterans and cancer survivors with mild to moderate PTSD symptoms. Because many of those experiencing trauma symptoms do not receive evidence-based care for PTSD, it is important to identify effective means of delivering efficacious treatments, like mindfulness-based interventions, using technology-based channels. In the proposed study, Veterans with PTSD will be recruited using social media advertising and will be randomized to one of 2 groups: no treatment control group or Mindfulness Coach mobile app. Participants in each of the 2 groups will be asked to complete measures of mindfulness and psychological well- being at baseline (prior to randomization) and again at 8-weeks (immediately post-treatment) and 16-weeks (8 weeks after completing treatment).

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

In brief, 200 community-dwelling veterans with significant, untreated PTSD symptoms will be randomized to one of 2 groups: a no-treatment control group for one month/30-days, followed by receiving the phone app. And a treatment group that will receive the Mobile app or Mindfulness Coach mobile phone app. Potential participants will be identified from targeted Facebook and other social media outreach efforts.

Investigators at Stanford/VAPAHCS will be responsible for recruitment of the Veteran sample. Those who view an advertisement will be directed to the study website, hosted by Stanford's Qualtrics domain, where they will be provided with information about the study, screened for eligibility, and then provided with an informed consent document. Participants will then be randomized to one of the two groups and provided with an invitation and hyperlink that either a) provides them with information about when they will next be contacted (30-days after initial assessment) (control group), or b) a link that allows them to download the study app (Mindfulness Coach) onto their smart phone. Participants in Group 1 will then be encouraged to use the Mindfulness Coach app as often or as little as they like. Outcomes will be evaluated using objective measures of engagement with the intervention, changes in self-report measures of mindful awareness, attention, and psychological well-being, and qualitative experiences (phone interview) associated with use of each intervention. Barriers to implementation and identified strategies for overcoming barriers will be catalogued over the duration of the study.

Description of Each Condition:

GROUP 1. Mindfulness Coach Mobile App (n = 100). Participants in this condition will complete 3 assessments: initial, end of month two and end of month four. Each participant, following initial assessment will be provided with a link to download the Mindfulness Coach mobile app as well as with brief recommendations for how to use the app over the subsequent 16 weeks of the study. Mindfulness Coach is a mobile app for iPhone and Android, developed by the VA National Center for PTSD in collaboration with National Center for Telehealth and Technology (T2). Mindfulness Coach has been widely downloaded and is the 2nd most popular VA app available to the general public. Mindfulness Coach provides 4 primary treatment components: 1) psychoeducation about PTSD and Mindfulness (e.g., "What is Mindfulness?", "Why Practice Mindfulness?", "Mindfulness for Veterans", "Benefits of Mindfulness for PTSD", "Practice Challenges with PTSD", and "PTSD Symptoms During Practice"), 2) self-monitoring tools for tracking mindfulness practice, 3) 9 audio- guided mindfulness exercises (e.g., "Mindful Breathing", "Body Scan", "Clouds in the Sky", etc.), and 4) reminders to regularly practice mindfulness exercises.

GROUP 2. Will serve, initially, as a No Treatment Control Group (n = 100) for 60- days (one-month). Participants in this condition will initially be provided with links to resources for Veterans with PTSD (http://ptsd.va.gov) and will be told that they will be contacted again in 8 weeks (60 days) to complete a second assessment. Each participant will then be provided with a link to download the Mindfulness Coach mobile app and with brief recommendations for how to use the app over the subsequent 8 weeks of the study (see description above). Participants will participate in a final follow up survey 8 weeks after receiving the app.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

200

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • California
      • Menlo Park, California, Vereinigte Staaten, 94025
        • Rekrutierung
        • VA Palo Alto Health Care System Menlo Park Division
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • PTSD Diagnosis
  • Veteran Status
  • Must own personal smartphone/tablet with internet connection
  • English fluency

Exclusion Criteria:

  • Under 18

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Mindfulness Coach Mobile App
Participants in this condition will complete 3 assessments: initial, end of month two and end of month four. Each participant, following initial assessment will be provided with a link to download the Mindfulness Coach mobile app as well as with brief recommendations for how to use the app over the subsequent 16 weeks of the study. Mindfulness Coach is a mobile app for iPhone and Android, developed by the VA National Center for PTSD in collaboration with National Center for Telehealth and Technology (T2).
Sonstiges: Mindfulness Coach
Mindfulness Coach provides 4 primary treatment components: 1) psychoeducation about PTSD and Mindfulness (e.g., "What is Mindfulness?", "Why Practice Mindfulness?", "Mindfulness for Veterans", "Benefits of Mindfulness for PTSD", "Practice Challenges with PTSD", and "PTSD Symptoms During Practice"), 2) self-monitoring tools for tracking mindfulness practice, 3) 9 audio- guided mindfulness exercises (e.g., "Mindful Breathing", "Body Scan", "Clouds in the Sky", etc.), and 4) reminders to regularly practice mindfulness exercises.
Kein Eingriff: No Treatment Control Group
Participants in this condition will initially be provided with links to resources for Veterans with PTSD (http://ptsd.va.gov) and will be told that they will be contacted again in 8 weeks (60 days) to complete a second assessment. Each participant will then be provided with a link to download the Mindfulness Coach mobile app and with brief recommendations for how to use the app over the subsequent 8 weeks of the study (see description above). Participants will participate in a final follow up survey 8 weeks after receiving the app.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mindfulness Questionnaire
Zeitfenster: 8 weeks
This is a 7-item questionnaire which asks participants to rate their ability to practice, and attitude towards mindfulness meditation practices. Mindfulness meditation in the clinical context is defined as nonjudgmental attention to present-moment experiences. Originally stemming from Buddhist tradition, it guides users to the regulation of their attention to maintain their focus on immediate experiences such as thoughts, emotions, body posture and sensations, and the ability to approach one's experiences with openness and acceptance. The minimum score on this scale is 7, maximum 35. Some items are reverse-coded, and possible responses include "Strongly disagree", "Somewhat disagree", "Neither agree nor disagree", "Somewhat agree", or "Strongly agree". Higher scores indicate an increased mindfulness practice capability, which is the better outcome. Responses are summed.
8 weeks
PEG Pain Scale
Zeitfenster: 8 weeks
PEG is a 3-item questionnaire assessing Pain Intensity and Interference. Pain is measured on a 0 to 10 scale by asking participants to rate their pain over the past week. Responding 0 to any item indicates "No pain", whereas 10 is "Pain as bad as you can imagine". It also asks how much pain interferes with their enjoyment of life and general activity. The minimum score is 0, and maximum is 30. Lower score is the better outcome. Responses are summed.
8 weeks
PROMIS (Patient-Reported Outcomes Measurement Information System) Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a
Zeitfenster: 8 weeks
PROMIS is an 8-item questionnaire which assesses sleep quality, such as if they feel rested after sleeping, or still feel tired after they wake up, and if that impacts their quality of life. Some items are reverse-coded, and possible responses include "Not at all", "A little bit", "Somewhat", "Quite a bit", or "Very much". The minimum score is 8, and the maximum is 40. Lower score is the better outcome. Responses are summed.
8 weeks
Acceptance and Action Questionnaire (AAQ-II)
Zeitfenster: 8 weeks
AAQ-II is a 10-item questionnaire on how personal memories effect feelings of anxiety and control over one's life. The Acceptance and Action Questionnaire measures experiential avoidance and psychological inflexibility, such as the avoidance of thoughts and feelings, ability to distinguish negative thoughts from objective facts about the situation, and behavioral adjustment in the presence of difficult thoughts or feelings. It is used to predict a wide-range of quality of life outcomes (e.g., depression, anxiety, general mental health, job satisfaction, future work absence, and future job performance. Some items are reverse-coded, and possible responses include "Never true", "Very seldom true", "Seldom true", "Sometimes true", "Frequently true", "Almost always true", or "Always true". The minimum score is 10, and the maximum is 70. Lower score is the better outcome. Responses are summed.
8 weeks
PTSD Checklist for DSM-5 (PCL-5)
Zeitfenster: 8 weeks
The PCL-5 is a 20-item questionnaire that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including: Monitoring symptom change during and after treatment, Screening individuals for PTSD, Making a provisional PTSD diagnosis. Possible responses include "Not at all", "A little bit", "Moderately", "Quite a bit", or "Extremely". The minimum score is 0, and the maximum is 80. Lower score is the better outcome. Responses are summed.
8 weeks
Patient Health Questionnaire (PHQ-9)
Zeitfenster: 8 weeks
PHQ-9 is a 10-item questionnaire that assesses the DSM-5 symptoms of Major Depression over the past two weeks. These are operationalized in the amount of impact on respondents daily functioning the symptoms have with possible responses include "Not at all", "Several days", "More than half the days", "Nearly every day". The minimum score is 0, and the maximum is 36. Lower score is the better outcome. Responses are summed.
8 weeks
Generalized Anxiety Disorder 7 (GAD-7)
Zeitfenster: 8 weeks
GAD-7 is a 7-item questionnaire that assesses the DSM-5 symptoms of Generalized Anxiety Disorder symptoms over the past two weeks. These are operationalized in the amount of impact on respondents daily functioning the symptoms have with possible responses include "Not at all", "Several days", "More than half the days", "Nearly every day". The minimum score is 0, and the maximum is 28. Lower score is the better outcome. Responses are summed.
8 weeks
The Brief Inventory of Psychosocial Functioning (B-IPF)
Zeitfenster: 8 weeks
B-IPF is a 7-item questionnaire that assesses posttraumatic stress disorder (PTSD)-related psychosocial functional impairment over the past month. These are operationalized in the amount of difficulty participants have in their social relationships because of their PTSD symptoms. Possible responses include "0 Not at all", "1", "2", "3 Somewhat", "4", "5", "6 Always", or "N/A". The minimum score is 0, and the maximum is 42. Lower score is the better outcome. Responses are summed.
8 weeks
World Health Organization Quality of Life, abbreviated version (WHOQOL) - BREF
Zeitfenster: 8 weeks
WHOQOL - BREF is a 27-item questionnaire that assesses overall quality of life across 4 subscales over the past two weeks. The first is Physical Health, such as Activities of daily living, Dependence on medicinal substances and medical aids. Second is Psychological, such as Bodily image and appearance, memory and concentration. Third is Social relationships, such as Social support and Sexual activity. And fourth is Environment, such as Financial Resources and Physical safety and security. These subgroups are analyzed separately and not summed. Possible responses include "Very dissatisfied", "Dissatisfied", "Neither satisfied nor dissatisfied", "Satisfied", and "Very satisfied" or "Not at all", "A little", "Moderately", "Mostly", "Completely". Some items are reverse-coded. The minimum score is 27, and the maximum is 135. Higher score is the better outcome. Responses are summed.
8 weeks
White Bear Suppression Inventory (WBSI)
Zeitfenster: 8 weeks

WBSI is a 15-item questionnaire that is designed to measure thought suppression. Chronic thoughts suppression is a variable that is related to obsessive thinking and negative affect associated with depression and anxiety. The WBSI can help to identify individuals who are more prone to develop chronic thought suppression as well as individuals who express wishing they were not depressed, but are in fact depressed.

Possible responses include "Strongly disagree", "Disagree", "Neutral or don't know", "Agree", and "Strongly agree". The minimum score is 15, and the maximum is 75. Lower score is the better outcome. Responses are summed.
8 weeks
Five Facet Mindfulness Questionnaire
Zeitfenster: 8 weeks
Five Facet Mindfulness is a 39-item questionnaire which assesses the participant's awareness of their thoughts, emotions, and physical state at the current moment and in general. The five facets are observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. These subgroups can be analyzed separately or summed. Possible responses include "never or very rarely true", "rarely true", "sometimes true", "often true", or "often true or always true". Some items are reverse-coded. The minimum score is 39, and the maximum is 195. Lower score is the better outcome. Responses are summed.
8 weeks
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Zeitfenster: 8 weeks
Multidimensional Assessment of Interoceptive Awareness is a 32-item questionnaire, of which 17 were selected, which assesses the participant's bodily awareness. It allows a more differentiated assessment of essential psychological aspects of the perception and evaluation of body sensations. The four subscales evaluated are Noticing, Not-Distracting, Not-Worrying, and Attention Regulation. Possible responses include "0 Never", "1", "2", "3", "4" or "5 Always". Higher total scores and subscale scores indicate higher levels of positive awareness, the better outcome. The minimum score is 0, and the maximum is 85. Some items are reverse coded, and subscales are averaged separately, then summed.
8 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

VA Palo Alto Health Care System

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

24. Juli 2019

Primärer Abschluss (Voraussichtlich)

1. August 2020

Studienabschluss (Voraussichtlich)

1. August 2020

Studienanmeldedaten

Zuerst eingereicht

24. Juli 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Juli 2019

Zuerst gepostet (Tatsächlich)

29. Juli 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. August 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. August 2019

Zuletzt verifiziert

1. August 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 35540

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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