- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01398891
Development of a Positive Psychology Intervention to Reduce Suicide Risk (HOPE)
This pilot study will recruit patients admitted to the inpatient psychiatric unit at MGH for suicidal ideation or a suicide attempt. Inclusion criteria will be broad to increase enrollment rates and obtain information for patients with a wide range of diagnoses and illness severity. Enrolled subjects will complete randomly-selected positive psychology exercises daily (on weekdays) until discharge and will rate the exercises in multiple domains. Subjects' participation will be complete at the end of their admission or when all exercises have been completed, whichever comes first.
Overall, our goal is to assess the acceptability and utility of eight possible positive psychology interventions related to gratitude, optimism, kindness, mindfulness, recollection, and forgiveness in suicidal inpatients.
This is a single-arm study, completed with patients who have been admitted to the hospital for suicidal ideation or a suicide attempt. It is aimed at developing a positive psychology treatment aimed at suicidal patients. The study consists of serial completion of different positive psychology exercises, once daily, during admission, to get subjects' input on their feasibility and impact. This will allow us to work collaboratively to identify the specific exercises that best fit this population. Subjects' participation ends when they are discharged from the hospital. The investigators plan to enroll 30 subjects at MGH (and total) in this study.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Adult (age 18 and older) admitted to inpatient psychiatric unit at Massachusetts General Hospital
- Suicidal ideation at time of admission OR
- Admission occurring in context of suicide attempt
- Ability to read and write in English
Exclusion Criteria:
- Psychotic symptoms
- Cognitive disorder
Studieplan
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 |
|---|---|
|
Experimentell: Positive Psychology Exercises
|
At each session, the interventionalist will prepare the subject to complete a randomly-selected positive psychology exercise, lasting approximately 20 minutes, within the next 24 hours.
He or she will describe the rationale for the exercise and the details of the exercise, and will answer any questions.
A sheet with written instructions (matching the verbal instructions) for the exercise will be provided, with space for recording the exercise and an area to provide ratings on the exercise.
On the following day, the interventionalist will review the prior day's exercise (and record whether it was completed).
The exercises will be completed daily on weekdays for a maximum of 8 days.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Completion of exercises
Tidsram: Every 24 hours until all exercises administered or discharge occurs
|
Exercises assigned each day and assessed for completion the next day (a total of eight exercises)
|
Every 24 hours until all exercises administered or discharge occurs
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Optimism
Tidsram: Baseline and on the date of discharge (average length of admission= 2 weeks)
|
Life Orientation Test-Revised
|
Baseline and on the date of discharge (average length of admission= 2 weeks)
|
|
Feasibility and utility of exercises
Tidsram: Assessed within 24 hours of exercise completion
|
Self-report using Likert scale
|
Assessed within 24 hours of exercise completion
|
|
Hopelessness
Tidsram: Baseline and on the date of discharge (average length of admission=2 weeks)
|
Beck Hopelessness Scale
|
Baseline and on the date of discharge (average length of admission=2 weeks)
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2010P002826
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
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 .