Online Emotional Regulation Group Treatment
1. oktober 2015 oppdatert av: Icahn School of Medicine at Mount Sinai
Online Emotional Regulation Group Treatment for Individuals With Traumatic Brain Injury (TBI)
This study will examine the feasibility of online delivery of emotional regulation training to individuals with TBI with emotional dysregulation.
80 subjects with significant emotional dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online in group modality.
Attendance and compliance will be tracked, and outcomes will be monitored using online data collection methods.
Treatment satisfaction and participant subjective experience will also be assessed.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
This study will examine the feasibility of online delivery of emotional regulation training to individuals with Traumatic Brain Injury who also have emotional dysregulation.
80 subjects with significant emotional dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online via a group meeting software.
Study participation will last 28 weeks: 4 weeks of baseline, 12 weeks of treatment (24 sessions) and 12 weeks of follow-up.
Assessments will be conducted at each of four timepoints: T1 (baseline), T2 (pre-treatment assessment), T3 (end-of-treatment assessment) and T4 (follow-up assessment).
In addition, a subset of the measures will be administered bi-weekly for the duration of the study.
Assessments will consist of a variety of measures designed to measure executive functioning, problem solving skills, and quality of life.
All assessments will be completed online, using a web-based data collection.
Attendance and treatment compliance will be tracked, and outcomes will be monitored using online data collection methods.
Treatment satisfaction and participant subjective experience (including technical difficulties that make access to web-delivered treatment impossible) will also be assessed.
Studietype
Intervensjonell
Registrering (Faktiske)
147
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New York
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New York, New York, Forente stater, 10029
- The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Documented TBI of any severity and being at least 6 months post injury
- Presence of executive dysfunction, manifested as self-reported difficulties with emotional and behavioral self-regulation, operationalized as endorsement of 25% or more of the symptoms on the Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004).
- Currently aged 18 or older
- English speaking
- At least low average intellectual functioning, operationalized as a minimum Verbal IQ score of 80 on the Wechsler Abbreviated Scale of Intelligence
- Ownership of and relative facility with use of a computer, webcam, and microphone
- Access to a broadband internet connection at sufficiently high speed to allow videoconference
Exclusion Criteria:
- DSM-IV-TR diagnosis of alcohol or substance abuse within past 6 months
- DSM-IV-TR of psychosis within past 6 months
- High suicidality, operationalized as a score of 17 or higher on the Mini International Neuropsychiatric Interview (M.I.N.I., Sheehan et al., 2008)
Participation in this study will not preclude participation in other treatments.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Online Emotional Regulation Treatment
Participants will receive 24 treatment sessions, with baseline, post-treatment screening and follow-up screening, and bi-weekly assessments
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Emotional Regulation Training (EmReg) is a cognitive-behavioral approach which aims to increase awareness, and self-monitoring of affective states to improve self-regulation.
EmReg combines didactic and experiential training, and emphasizes skill acquisition and generalization through examination of incidents of emotional dysregulation in one's life and completion of homework assignments.
The treatment is divided into two phases: knowledge provision and practice facilitation.
During the knowledge provision phase participants are introduced to the objectives and the main concepts of the treatment, to increase their familiarity with the terminology, and to the emotional regulation skills they acquire during the practice facilitation phase.
During the practice facilitation phase participants receive training in emotional regulation skills, which they practice in-session with the guidance of the therapist and feedback from the group, as well as out-of-session as homework assignments.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Difficulties in Emotion Regulation Scale(DERS)
Tidsramme: up to 28 weeks
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36-item self-report questionnaire that focuses on emotional awareness, acceptance, ability to control impulsivity, and flexible use of strategies
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up to 28 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The Brain Injury Rehabilitation Trust Regulation of Emotions Questionnaire (BREQ)
Tidsramme: up to 28 weeks
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32 item self-report questionnaire assessing deficits in emotion regulation, developed specifically to assess emotional dysregulation related to TBI
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up to 28 weeks
|
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Problem Solving Inventory
Tidsramme: up to 28 weeks
|
35-item self-report questionnaire assessing problem solving capability
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up to 28 weeks
|
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Social Problem Solving Inventory-Revised: Short Form
Tidsramme: up to 28 weeks
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25-item self-report questionnaire assessing problem solving in everyday living
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up to 28 weeks
|
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Positive Affect Negative Affect Scale
Tidsramme: up to 28 weeks
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20-item self-report measure of positive and negative affect within a specified time frame
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up to 28 weeks
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Satisfaction with Life Scale
Tidsramme: T1 (baseline)
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5- item measure of global satisfaction with life
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T1 (baseline)
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Satisfaction with Life Scale
Tidsramme: T2 (week 4)
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5- item measure of global satisfaction with life
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T2 (week 4)
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Satisfaction with Life Scale
Tidsramme: T3 (week 16)
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5- item measure of global satisfaction with life
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T3 (week 16)
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Satisfaction with Life Scale
Tidsramme: T4 (week 28)
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5- item measure of global satisfaction with life
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T4 (week 28)
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Satisfaction with Therapy and Therapist Scale
Tidsramme: T3 (week 16)
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12-item scale that assesses satisfaction with treatment and therapist
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T3 (week 16)
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Satisfaction with Therapy and Therapist Scale
Tidsramme: T4 (week 28)
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12-item scale that assesses satisfaction with treatment and therapist
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T4 (week 28)
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Treatment Compliance
Tidsramme: up to 28 weeks
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therapist's ratings of participant on each of the following areas at each session: attendance, participation, homework completion, skill acquisition, skill generalization, ease of use of technology, and interpersonal behavior
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up to 28 weeks
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Samarbeidspartnere og etterforskere
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2012
Primær fullføring (Faktiske)
1. oktober 2015
Studiet fullført (Faktiske)
1. oktober 2015
Datoer for studieregistrering
Først innsendt
15. november 2012
Først innsendt som oppfylte QC-kriteriene
15. november 2012
Først lagt ut (Anslag)
21. november 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
2. oktober 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. oktober 2015
Sist bekreftet
1. oktober 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GCO 12-1256-3
- HSM 12-00760
- IF1435434
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