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Computer-Aided Learning for Managing Stress (CALMS)

22. februar 2018 opdateret af: Kristen Woodberry, Beth Israel Deaconess Medical Center

A Pilot Study of Computerized Biofeedback Games With Young People Experiencing Psychotic-Spectrum Symptoms

The purpose of this study is to learn whether a new family therapy using computer games with biofeedback might help people at clinical high risk for psychosis and their family members learn to experience less stress and have fewer mental health challenges.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

CALMS revolves around the use of Emotional Manipulatives (EM) developed at Boston Children's Hospital (BCH). EM are single and multi-user biofeedback games designed to enhance executive control of emotion. The intervention and EM in CALMS were adapted from those used in Anger Control Training (ACT) with Regulate and Gain Emotional Control (RAGE-Control). In a randomized controlled trial at BCH, ACT and RAGE-Control relative to "sham" video-game play without biofeedback led to significantly greater reductions of aggression in adolescents and greater improvement in family functioning.

In this feasibility study, family dyads will participate in 12 sessions aimed at

  1. enhancing engagement through the use of video and other games,
  2. enhancing stress resilience through biofeedback, education, and individualized stress-reduction practice, and
  3. harnessing the power of the family to enhance contextual learning and the generality and duration of effects.

Clinical, self-report, and heart rate measures will be assessed at baseline, 4, 8, and 12 week assessments.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

25

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Beth Israel Deaconess Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 30 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Currently Meet or Have Met Criteria of Prodromal Syndromes (COPS) according to the SIPS within the past 2 years
  • Estimated IQ > 70
  • Speak fluent English
  • Have at least one parent or adult family member who also speaks fluent English and is willing to participate

Exclusion Criteria:

  • Physical limitations precluding effective use of biofeedback videogames
  • Co-morbid psychiatric disorders, including substance disorders, but only if they better explain COPS symptoms or make participation counter-indicated.
  • Active suicidal ideation or attempts within the past 2 months unless being actively monitored and treated for this by a clinician

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CALMS
12 session family therapy using multi-user biofeedback games
Adfærdsmæssigt: CALMS
Family Therapy; Multi-user Biofeedback Videogames

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility: Percent of referred who consent and meet study criteria
Tidsramme: Up to six months
Enrollment
Up to six months
Feasibility: Percent of 12 sessions completed
Tidsramme: Up to six months
Engagement: Percent of sessions completed by consented and eligible participants
Up to six months
Feasibility: Counts of premature termination of intervention
Tidsramme: Up to six months
Up to six months
Feasibility: Self-report of Credibility/Satisfaction
Tidsramme: 12 week assessment or last assessment completed
Individual and family member self-report
12 week assessment or last assessment completed
Feasibility: Self-report of User Experience
Tidsramme: 12 week assessment or last assessment completed
Self-report of ability to learn/use technology to lower stress reactivity
12 week assessment or last assessment completed

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Perceived Stress relative to Baseline
Tidsramme: Weeks 4, 8, and 12 Assessments
Self-report via Perceived Stress Scale
Weeks 4, 8, and 12 Assessments
Change relative to Baseline in Youth Perceptions of Relationship with Family Member
Tidsramme: Weeks 4, 8, 12 Assessments
Self-report of conflict, criticism, and warmth in relationship with participating family member
Weeks 4, 8, 12 Assessments
Change relative to Baseline in Parent Perceptions of Relationship with Adolescent or Young Adult
Tidsramme: Weeks 4, 8, 12 Assessments
Self-report of conflict, criticism, and warmth in relationship with youth
Weeks 4, 8, 12 Assessments
Positive Symptom Score Change relative to Baseline
Tidsramme: Weeks 4,8, and 12 Assessments
Total positive symptom score according to the Structured Interview of Psychosis-risk Syndromes (SIPS)
Weeks 4,8, and 12 Assessments
Change in Social and Role Functioning relative to Baseline
Tidsramme: Weeks 4, 8, and 12 Assessments
Global Functioning: Social & Role Scales;
Weeks 4, 8, and 12 Assessments
Change in Global Functioning relative to Baseline
Tidsramme: Weeks 4, 8, and 12 Assessments
SIPS Global Assessment of Functioning
Weeks 4, 8, and 12 Assessments
Safety: Change in Hostility/Aggression relative to Baseline
Tidsramme: Weeks 4, 8, and 12
Self-report
Weeks 4, 8, and 12
Safety: Change in Video-game Addiction relative to Baseline
Tidsramme: Weeks 4, 8, and 12
Self-report
Weeks 4, 8, and 12
Difference in reaction times for emotional and calm faces on an Emotional Go/NoGo Task
Tidsramme: Baseline, Weeks 4,8, and 12
Executive Control of Emotion
Baseline, Weeks 4,8, and 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beth Israel Deaconess Medical Center

Samarbejdspartnere

National Institute of Mental Health (NIMH)
Boston Children's Hospital

Efterforskere

  • Ledende efterforsker: Kristen Woodberry, MSW, Ph.D., Beth Israel Deaconess Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2015

Primær færdiggørelse (Faktiske)

5. januar 2018

Studieafslutning (Faktiske)

5. januar 2018

Datoer for studieregistrering

Først indsendt

13. juli 2015

Først indsendt, der opfyldte QC-kriterier

21. august 2015

Først opslået (Skøn)

24. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. februar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. februar 2018

Sidst verificeret

1. februar 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2012P000377
  • K23MH102358 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Psykose

Kliniske forsøg med CALMS

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Papua New Guinea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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