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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01398891
Other study ID # 2010P002826
Secondary ID
Status Completed
Phase N/A
First received July 15, 2011
Last updated March 4, 2013
Start date May 2011
Est. completion date March 2013

Study information

Verified date March 2013
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Other:
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.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Completion of exercises 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 No
Secondary Optimism Life Orientation Test-Revised Baseline and on the date of discharge (average length of admission= 2 weeks) No
Secondary Feasibility and utility of exercises Self-report using Likert scale Assessed within 24 hours of exercise completion No
Secondary Hopelessness Beck Hopelessness Scale Baseline and on the date of discharge (average length of admission=2 weeks) No
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