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Positive Psychology for Mood Disorders (PPBPAD)

Primary Purpose

Bipolar Disorder, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive psychology intervention
Recollection intervention
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar disorder, Depression, Positive psychology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient admitted to Massachusetts General Hospital Inpatient Psychiatric Unit
  • Age 18 and older
  • Able to read and write in English
  • Admission diagnosis of major depressive disorder or bipolar affective disorder (current depressive episode), confirmed using the Mini International Neuropsychiatric Interview and inpatient chart review

Exclusion Criteria:

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Positive psychology intervention

Recollection intervention

Arm Description

4-week positive psychology intervention of 1 positive psychology exercise per week. Exercises will include 1) recalling 3 good events, 2) writing a letter of thankfulness, 3) using a personal strength, 4) envisioning a best possible future.

4-week recollection intervention of 1 recollection exercise per week. Exercises will include recalling events related to 1) daily activities, 2) health, 3) social life, 4) morning and evening.

Outcomes

Primary Outcome Measures

Feasibility of positive psychology exercises
Feasibility will be measured by: Completion rate of exercises Ease of exercises (rated on a 5-point scale) Helpfulness of exercises (rated on a 5-point scale)

Secondary Outcome Measures

Impact of positive psychology exercises on positive affect
Positive affect will be measured by: Optimism score on the Life Orientation Test-Revised (scores range from 3 to 30, with higher scores indicating higher levels of optimism) Gratitude score on the Gratitude Questionnaire-6 (scores range from 6 to 42, with higher scores indicating higher levels of gratitude) Positive emotion score on the Positive and Negative Affect Scale (scores range from 10 to 50, with higher scores indicating higher levels of positive emotion)
Impact of positive psychology exercises on negative affect
Negative affect will be measured by: Hopelessness scores on the Beck Hopelessness Scale (scores range from 0 to 20, with higher scores indicating higher levels of hopelessness). Suicidal ideation scores on the Concise Health Risk Tracking scale (scores range from 12 to 60, with higher scores indicating higher levels of suicidal ideation) Depression scores on the Quick Inventory of Depressive Symptomatology-Self Report (scores range from 0 to 27, with higher scores indicating higher levels of depression)

Full Information

First Posted
March 25, 2013
Last Updated
September 1, 2017
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01820286
Brief Title
Positive Psychology for Mood Disorders
Acronym
PPBPAD
Official Title
Trial of a Positive Psychology Intervention to Reduce Suicide Risk in Patients With Mood Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 10, 2016 (Actual)
Study Completion Date
June 10, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators are doing this study to see if "positive psychology" can help adults with depression or bipolar disorder. Positive psychology involves exercises-short tasks-that try to increase good feelings and emotions, like optimism, happiness, personal strengths, and well-being. Positive psychology exercises might include imagining a bright future, being grateful for good events, forgiving others, and doing kind acts for others. The investigators want to see if practicing positive psychology exercises after leaving the hospital can increase feelings of hope, optimism, and positive thinking. The investigators are asking you to take part in this research study because you are in the hospital for depression or bipolar disorder. This research study will compare "positive psychology exercises" to "control condition exercises." During the study, you may take part in control condition exercises instead of positive psychology exercises.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Depression
Keywords
Bipolar disorder, Depression, Positive psychology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive psychology intervention
Arm Type
Experimental
Arm Description
4-week positive psychology intervention of 1 positive psychology exercise per week. Exercises will include 1) recalling 3 good events, 2) writing a letter of thankfulness, 3) using a personal strength, 4) envisioning a best possible future.
Arm Title
Recollection intervention
Arm Type
Active Comparator
Arm Description
4-week recollection intervention of 1 recollection exercise per week. Exercises will include recalling events related to 1) daily activities, 2) health, 3) social life, 4) morning and evening.
Intervention Type
Behavioral
Intervention Name(s)
Positive psychology intervention
Intervention Type
Behavioral
Intervention Name(s)
Recollection intervention
Primary Outcome Measure Information:
Title
Feasibility of positive psychology exercises
Description
Feasibility will be measured by: Completion rate of exercises Ease of exercises (rated on a 5-point scale) Helpfulness of exercises (rated on a 5-point scale)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Impact of positive psychology exercises on positive affect
Description
Positive affect will be measured by: Optimism score on the Life Orientation Test-Revised (scores range from 3 to 30, with higher scores indicating higher levels of optimism) Gratitude score on the Gratitude Questionnaire-6 (scores range from 6 to 42, with higher scores indicating higher levels of gratitude) Positive emotion score on the Positive and Negative Affect Scale (scores range from 10 to 50, with higher scores indicating higher levels of positive emotion)
Time Frame
8 weeks
Title
Impact of positive psychology exercises on negative affect
Description
Negative affect will be measured by: Hopelessness scores on the Beck Hopelessness Scale (scores range from 0 to 20, with higher scores indicating higher levels of hopelessness). Suicidal ideation scores on the Concise Health Risk Tracking scale (scores range from 12 to 60, with higher scores indicating higher levels of suicidal ideation) Depression scores on the Quick Inventory of Depressive Symptomatology-Self Report (scores range from 0 to 27, with higher scores indicating higher levels of depression)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient admitted to Massachusetts General Hospital Inpatient Psychiatric Unit Age 18 and older Able to read and write in English Admission diagnosis of major depressive disorder or bipolar affective disorder (current depressive episode), confirmed using the Mini International Neuropsychiatric Interview and inpatient chart review Exclusion Criteria: Psychotic symptoms, as assessed using the Mini International Neuropsychiatric Interview and inpatient chart review Cognitive disorder, assessed using a six-item cognitive screen developed for research Primary admission diagnosis of substance use disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff C Huffman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Positive Psychology for Mood Disorders

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