An interventional study of Positive Psychology and Control Condition in Major Depressive Disorder, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-19.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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:
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 65 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The Positive Psychology intervention consists of 6 exercises that will be completed by the participant with the guidance of a trainer. Exercises: Gratitude for positive events Gratitude letter Performing acts of kindness Using personal strengths Enjoyable and meaningful activities: Repeating one of the previous exercises.
Behavioral: Positive Psychology
The Control Condition consists of 6 exercises that will be completed by the participant with the guidance of a trainer. Exercises: Daily Events Health Events Morning and Evening Events Interactions with Others Leisure Time Activities Repeating one of the previous exercises.
Behavioral: Control Condition
The Positive Psychology intervention consists of 6 exercises that will be completed by the participant with the guidance of a trainer.
The Control Condition consists of 6 exercises that will be completed by the participant with the guidance of a trainer.
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.
Time frame: Baseline, 6 weeks, and 12 weeks
Change in CHRT Scores
The Concise Health Risk Tracking scale (CHRT) is a brief, twelve item, self-report and clinician rating of suicidal risk.
Time frame: Baseline, 6 weeks, and 12 weeks
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).
Time frame: Baseline, 6 weeks, and 12 weeks
Change in LOT-R Scores
The Life Orientation Test-Revised (LOT-R) is a validated, six item, self-report measure of optimism.
Time frame: Baseline, 6 weeks, and 12 weeks
Change in GQ-6 Scores
The Gratitude Questionnaire 6 is a brief, validated six-item measure of dispositional gratitude.
Time frame: Baseline, 6 weeks, and 12 weeks
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.
Time frame: Baseline, 6 weeks, and 12 weeks
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.
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
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.
Time frame: 12 weeks
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.
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Readmissions
Number of readmissions to the hospital
Time frame: 12 weeks
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Massachusetts General Hospital