Bipolar DisorderPPBPADNCT01820286
Positive Psychology for Mood Disorders
A study testing Positive psychology intervention and Recollection intervention in people with Bipolar Disorder and Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Depression
- What is being tested?
- Positive psychology intervention and Recollection intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to 10 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Trial of a Positive Psychology Intervention to Reduce Suicide Risk in Patients With Mood Disorders
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.
Read more
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.
- Conditions
- Bipolar Disorder, Depression
- Being tested
- Positive psychology intervention, Recollection intervention
- Keywords
- Bipolar disorder, Depression, Positive psychology
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive psychology interventionBehavioural
Recollection interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Positive psychology intervention | Experimental | 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. Receives: Behavioral: Positive psychology intervention |
| Recollection intervention | Active comparator | 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. Receives: Behavioral: Recollection intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 weeks
Secondary outcomes (2)
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)
Measured: 8 weeks
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)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startMar 2013
- Primary completion10 Jun 2016
- Study completion10 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff C. Huffman, MD, Massachusetts General Hospital
- Investigators
- Jeff C Huffman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820286
- Sponsor's protocol ID
- 2012P002294
- Acronym
- PPBPAD
- Status last verified
- Sep 2017
- First submitted
- 25 Mar 2013
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of a Positive Psychology Intervention to Reduce Suicide Risk in Patients With Mood Disorders
- ClinicalTrials.gov ID
- NCT01820286
- Acronym / sponsor ID
- PPBPAD / 2012P002294
- Conditions
- Bipolar Disorder, Depression
- Keywords
- Bipolar disorder, Depression, Positive psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- 10 Jun 2016 (actual)
- Study completion
- 10 Jun 2016 (actual)
- First posted
- 28 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive psychology intervention | Experimental | Behavioral: Positive psychology intervention4-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. |
| Recollection intervention | Active comparator | Behavioral: Recollection intervention4-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive psychology intervention | Behavioural | Positive psychology intervention |
| Recollection intervention | Behavioural | Recollection intervention |
Primary outcome
Feasibility of positive psychology exercises
Time frame: 8 weeks
Feasibility will be measured by: 1. Completion rate of exercises 2. Ease of exercises (rated on a 5-point scale) 3. Helpfulness of exercises (rated on a 5-point scale)
2 secondary outcomes
Impact of positive psychology exercises on positive affect
Time frame: 8 weeks
Impact of positive psychology exercises on negative affect
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff C Huffman, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive psychology intervention and Recollection intervention in people with Bipolar Disorder and Depression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of positive psychology exercises (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.