Trial of a Positive Psychology Intervention in Major Depressive Disorder

Completed · Not applicable

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT02004145

Run by

Massachusetts General Hospital

People needed

65

Starts

2013-10-01

Expected to finish

2015-09-01

Last updated by the study team

2016-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient admitted to Massachusetts General Hospital inpatient psychiatric unit
• Age 18 and older
• Able to read/write in English
• SI documented on admission OR admission due to a suicide attempt
• Admission diagnosis of MDD (and current major depressive episode), confirmed using the Mini International Neuropsychiatric Interview (MINI) and inpatient chart review

You may not qualify if…

• Psychotic symptoms, as assessed using the MINI and inpatient chart review
• Cognitive disorder, assessed using a six-item cognitive screen developed for research
• Primary admission diagnosis of substance use disorder

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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