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Trial of a Positive Psychology Intervention in Major Depressive Disorder (HOPE)

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ClinicalTrials.gov Identifier: NCT02004145
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : April 19, 2016
Sponsor:
Collaborator:
American Foundation for Suicide Prevention
Information provided by (Responsible Party):
Jeff C. Huffman, MD, Massachusetts General Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Positive Psychology Behavioral: Control Condition Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trial of a Positive Psychology Intervention to Reduce Suicide Risk in Patients With Major Depression
Study Start Date : October 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Positive Psychology

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 Positive Psychology intervention consists of 6 exercises that will be completed by the participant with the guidance of a trainer.

Sham Comparator: Organizational Skills

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 Control Condition consists of 6 exercises that will be completed by the participant with the guidance of a trainer.




Primary Outcome Measures :
  1. Change in BHS Scores [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in CHRT Scores [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
    The Concise Health Risk Tracking scale (CHRT) is a brief, twelve item, self-report and clinician rating of suicidal risk.

  2. Change in QIDS-SR Scores [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
    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).


Other Outcome Measures:
  1. Change in LOT-R Scores [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
    The Life Orientation Test-Revised (LOT-R) is a validated, six item, self-report measure of optimism.

  2. Change in GQ-6 Scores [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
    The Gratitude Questionnaire 6 is a brief, validated six-item measure of dispositional gratitude.

  3. Change in PANAS Scores [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
    The Positive Affect Negative Affect Schedule (PANAS) consists of ten words that subjects rate on a 5-point likert scale to asses positive affect.

  4. Ease of Exercises [ Time Frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 ]
    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.

  5. Rate of Intervention Feasibility [ Time Frame: 12 weeks ]
    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.

  6. Immediate Impact of Exercises [ Time Frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 ]
    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.

  7. Readmissions [ Time Frame: 12 weeks ]
    Number of readmissions to the hospital



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004145


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
American Foundation for Suicide Prevention
Investigators
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Principal Investigator: Jeff C Huffman, MD Massachusetts General Hospital

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Responsible Party: Jeff C. Huffman, MD, Medical Director, Blake 11, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02004145     History of Changes
Other Study ID Numbers: 2013P001234
SRG-2-019-12 ( Other Grant/Funding Number: AFSP )
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

Keywords provided by Jeff C. Huffman, MD, Massachusetts General Hospital:
MDD
Positive Psychology
Suicidality

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms