Major Depressive Disorder Clinical Trial
— HOPEOfficial title:
Trial of a Positive Psychology Intervention to Reduce Suicide Risk in Patients With Major Depression
Verified date | April 2016 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 65 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | American Foundation for Suicide Prevention |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in LOT-R Scores | The Life Orientation Test-Revised (LOT-R) is a validated, six item, self-report measure of optimism. | Baseline, 6 weeks, and 12 weeks | No |
Other | Change in GQ-6 Scores | The Gratitude Questionnaire 6 is a brief, validated six-item measure of dispositional gratitude. | Baseline, 6 weeks, and 12 weeks | No |
Other | Change in PANAS Scores | The Positive Affect Negative Affect Schedule (PANAS) consists of ten words that subjects rate on a 5-point likert scale to asses positive affect. | Baseline, 6 weeks, and 12 weeks | No |
Other | Ease of Exercises | Ease of exercises will be measured by a self-report 10-point Likert scale (0=very difficult to complete, 10=very easy to complete). Ease will be defined as an average score of 6 or more on this scale. | Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | No |
Other | Rate of Intervention Feasibility | Rate of intervention feasibility will be measured by the number of exercises and follow-up assessments completed by each subject. There are 6 exercises and 2 follow-up assessments in total . A good rate of completion will be defined as an average of 4 or more exercises completed and >80% of follow-up assessments completed per subject. | 12 weeks | No |
Other | Immediate Impact of Exercises | Immediate impact of exercises will be measured by three self-report 10-point Likert scales measuring hopelessness (0=not hopeless, 10=very hopeless), mental organization (0=not organized, 10=very organized), and optimism (0=not optimistic, 10=very optimistic). Immediate impact will be defined as an average score of 6 or more on these scales. | Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | No |
Other | Readmissions | Number of readmissions to the hospital | 12 weeks | No |
Primary | Change in BHS Scores | The Beck Hopelessness Scale (BHS) is a validated, twenty item, self-report measure that assesses three major aspects of hopelessness: feelings about the future, loss of motivation, and expectations. | Baseline, 6 weeks, and 12 weeks | No |
Secondary | Change in CHRT Scores | The Concise Health Risk Tracking scale (CHRT) is a brief, twelve item, self-report and clinician rating of suicidal risk. | Baseline, 6 weeks, and 12 weeks | No |
Secondary | Change in QIDS-SR Scores | The Quick Inventory of Depressive Symptomatology—Self Report (QIDS-SR) is a sixteen item, self-report measure of depressive symptom severity derived from the 30-item Inventory of Depressive Symptomatology (IDS). | Baseline, 6 weeks, and 12 weeks | No |
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