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NCT02004145 · ClinicalTrials.gov registry record · NA
Trial of a Positive Psychology Intervention in Major Depressive Disorder
A NA study of Major Depressive Disorder, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT02004145 is a NA study of Major Depressive Disorder that has completed, run by Massachusetts General Hospital. The registered enrollment target is 65 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02004145, a NA study of Major Depressive Disorder, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, the investigators will perform an exploratory randomized trial of Positive Psychology (PP). The trial will consist of 50 participants and will compare the impact of a phone-based PP intervention vs. an attentional control condition, in Major Depressive Disorder (MDD) patients who are hospitalized for SI or following a suicide attempt. This is a 12 week trial with 6 weeks of intervention and two blinded follow-up assessments at 6 and 12 weeks. Specific Aim #1: To assess the feasibility and acceptability of the phone-based PP intervention in this high-risk population. Hypotheses: The intervention will be feasible (with most patients completing at least 4/6 PP and with follow-up data from at least 80% of subjects). The ratings of ease and subjective helpfulness of the exercise and other mental states as measured before and after each PP exercise will be more than 6 out of 10 and higher than the same ratings obtained from subjects in the control condition. Specific Aim #2: To examine the impact of the six-session PP intervention on positive psychological well-being. Hypothesis: Compared to control subjects, subjects randomized to PP will have greater scores on scales of optimism (measured via the Life Orientation Test-Revised \[LOT-R\]), gratitude (Gratitude Questionnaire-6 \[GQ-6\]), and positive affect (Positive Affect Negative Affect Schedule \[PANAS\]) at 6 and 12 weeks. Specific Aim #3 (primary aim): To assess the impact of the PP intervention on key suicide risk factors. Hypothesis: PP subjects will have greater scores on scales of hopelessness (Beck Hopelessness Scale \[BHS\]; primary study outcome measure), suicidal ideation (SI) (Concise Health Risk Tracking scale \[CHRT\]), and depression (Quick Inventory of Depressive Symptomatology-Self Report \[QIDS-SR\]) at 6 and 12 weeks. We will also measure impact on readmission and suicide attempts to assess these key outcomes.
Conditions Studied
Interventions
- BEHAVIORAL Control Condition
- BEHAVIORAL Positive Psychology
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2013-10 |
| Est. Completion | 2015-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02004145
The ClinicalTrials.gov registry entry for NCT02004145 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (83% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Control Condition is the first listed.
NCT02004145 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02004145 about?
NCT02004145 is a clinical study titled "Trial of a Positive Psychology Intervention in Major Depressive Disorder". In this study, the investigators will perform an exploratory randomized trial of Positive Psychology (PP). The trial will consist of 50 participants and will compare the impact of a phone-based PP intervention vs. an attentional control condition, in Major Depressive Disorder (MDD) patients who are ...
What is the current status of trial NCT02004145?
This trial is currently completed. It is a NA study. The enrollment target is 65 participants. The study started on 2013-10. Estimated completion is 2015-09.
What conditions does trial NCT02004145 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT02004145?
The interventions under investigation include: Control Condition (BEHAVIORAL), Positive Psychology (BEHAVIORAL).
Who is sponsoring clinical trial NCT02004145?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02004145 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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