Major Depressive Disorder Clinical Trial
Official title:
Trial of a Positive Psychology Intervention to Reduce Suicide Risk in Patients With Major Depression
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.
Participants will be randomized to receive the intervention or recollection (control) arm.
They will be randomized by a random-number generator and will be assigned a condition after
receiving baseline questionnaires. The RA/blinded assessor will be blind to the study
condition. The interventionist and subjects will not be blind to the study condition.
Baseline assessments: After consent and eligibility rule outs, subjects will receive
baseline questionnaires to assess hopelessness (BHS46), suicidality (CHRT47), depression
(QIDS-SR48), and positive states (LOT-R,43 GQ-6,44 PANAS45). Then, subjects will be
randomized via random number generator to receive the control or intervention condition.
After completing baseline questionnaires and receiving randomization, subjects in both
groups will have a 20 minute initial in-hospital session ("week #1"), within a week of
anticipated discharge, in which the interventionist will provide a treatment manual specific
to their condition, review the rationale for the initial exercise, and assign the exercise.
The next day, the exercise will be reviewed and an exercise assigned for the next week.
Immediately after completing the exercise, subjects will rate (on a Likert scale of 1-5)
ease of exercise completion, overall utility, and initial impact on hopelessness/optimism,
to assess immediate effects.
After discharge from the hospital, subjects will have five 20 minute weekly phone sessions
("weeks #2-6") with a different exercise used each week (assigned in the same order to all
subjects). The phone sessions will include: (a) review of the prior week's exercise
(including subject ratings of ease and impact as in week #1), (b) discussion of the
rationale and assignment of the next week's exercise via a guided review of the study
manual, and (c) completion of the Clinical Status questions and the Clinical Global
Improvement scale (CGI) to monitor symptoms and improvement. Sessions will be audiotaped and
random sessions reviewed by our PP consultant to ensure fidelity to the intervention (and
that other techniques, e.g., Cognitive Behavioral Therapy, are not used).
Positive psychology (intervention condition)
Exercises. These were selected based on their superior performance in our pre-pilot study
and others' work:
- Gratitude for positive events: Subjects recall three events, small or large, in the
preceding week that were associated with satisfaction, happiness, pride, or other
positive states.
- Gratitude letter: Subjects write a letter of gratitude thanking a person for an act of
kindness; subject may, at their discretion, share the letter with the other person.
- Performing acts of kindness: Subjects are instructed to complete three acts of kindness
in one day. The acts can be small or large, planned or spontaneous, but must be
expressly completed to be kind to another.
- Using personal strengths: Subjects undergo a brief assessment of personal strengths,
then find a new way to use that strength in the next 24 hours.
- Enjoyable and meaningful activities: Subjects complete a series of self-selected
activities that vary between those that bring immediate boosts in mood and those that
are more deeply meaningful.
- Repetition of an exercise previously done.
Recollection (control condition) The recollection condition was selected because it has been
used in a prior study by our team of a phone-based positive psychology intervention and it
was found to be feasible and well-accepted. Each week, subjects will record recent life
events in a manual without describing emotions associated with the events. The nature,
setting, or type of events to be recorded will differ each week to provide variety and
maintain subjects' interest. This will be described as an intervention that may assist with
organization and hone recall of important life events. Also, as an attentional control, it
has a parallel structure to the experimental arm with a treatment manual, weekly exercises,
and weekly calls to review exercises.
Follow-up 6 and 12 week phone call. After completion of the intervention (6 weeks), and then
at 12 weeks, a blinded study research assistant (RA) will call subjects at 6 and 12 weeks to
repeat measures of hopelessness (BHS), suicidality (CHRT), depression (QIDS-SR) and positive
states (e.g., GQ-6, PANAS, LOT-R). Subjects will also be asked to rate their overall
satisfaction with the treatment they received for their cardiac condition (outside of this
study) over the last 6 and 12 weeks on a scale of 1 (excellent) to 5 (poor). We will record
specific times that subjects would prefer to be called (and not to be called) for future
follow-ups, to reduce intrusion on subjects' lives. We will also send a postcard to subjects
reminding them of their upcoming study phone call. The blinded assessor will make 2
follow-up phone calls (at 6 and 12 weeks) to gather information about outcomes. If subjects
would rather complete the questions in written form rather than over the phone, we will send
them a written packet at the time of each follow-up.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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