Online Emotional Regulation Group Treatment
1 oktober 2015 uppdaterad 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
147
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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New York
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New York, New York, Förenta staterna, 10029
- The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai
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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
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
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: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Difficulties in Emotion Regulation Scale(DERS)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The Brain Injury Rehabilitation Trust Regulation of Emotions Questionnaire (BREQ)
Tidsram: 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
Tidsram: up to 28 weeks
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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
Tidsram: up to 28 weeks
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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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 november 2012
Primärt slutförande (Faktisk)
1 oktober 2015
Avslutad studie (Faktisk)
1 oktober 2015
Studieregistreringsdatum
Först inskickad
15 november 2012
Först inskickad som uppfyllde QC-kriterierna
15 november 2012
Första postat (Uppskatta)
21 november 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
2 oktober 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 oktober 2015
Senast verifierad
1 oktober 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GCO 12-1256-3
- HSM 12-00760
- IF1435434
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