Diabetes Mellitus, Type 2NCT03099928
Developing a Positive Psychology Intervention to Improve Health Behaviors in Type 2 Diabetes: Qualitative Research
An observational study of Diabetes Mellitus, Type 2, run by Massachusetts General Hospital.
Trial summary
Specific Aim #1 (Qualitative Research): To identify, through qualitative research, deficits in positive affect and associated barriers to completing health behaviors in type 2 DM patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 30 Nov 2016
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabetes patients admitted to three inpatient units or seen at the MGH Diabetes Center.
Who may be able to join
- Adult patients (21 years and older) admitted to one of the inpatient cardiac units (Ellison 9, 10, or11) at MGH or a current outpatient in the MGH Diabetes Center. Patients must have Type 2 Diabetes (confirmed via medical record and diabetologist/attending physician).
- Suboptimal adherence to health behaviors (diabetic diet, physical activity, medication), as measured by the Medical Outcomes Study Specific Adherence Scale (MOS SAS), as denoted by a score of <15 out of 18.
Who cannot join
- Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically-ill patients in research studies.24-26
- Medical conditions precluding interviews, determined in consultation with attending physician or diabetologist.
- Inability to communicate in English.
About this study
Specific Aim #1 (Qualitative Research): To identify, through qualitative research, deficits in positive affect and associated barriers to completing health behaviors in type 2 DM patients.
Hypothesis: Patients will be able to complete the structured interview, providing information about their own positive emotional states, identifying strategies to enhance positive emotions, linking the presence of positive emotions to better adherence to health-related behaviors, and identifying additional barriers to completing such behaviors.
Read more
Specific Aim #2 (Creation of intervention): To use the data gathered from qualitative and quantitative measures to create a positive psychology-based intervention
Hypothesis: Using the information provided in this trial, the investigators will be able to create an intervention, composed of several positive psychology exercises, that is well-matched with a diabetic population and is targeted to the enhancement adherence to health-related behaviors in this population. This intervention will then be ready for next stage testing.
Read the detailed description
The investigators are proposing to enroll 31 patients with type 2 DM following an outpatient visit to the MGH Diabetes Center or during admission to Ellison 9-11 inpatient units (or sometime in the following 14 days if the participant is not available to complete the interview after consenting for the study).
For these interviews, the investigators will discuss positive emotional states that patients have experienced and talk about ways they might increase these states. The investigators will also touch on health behaviors in which the patient has engaged and whether positive emotions played a role in completing these behaviors. To enhance the accessibility of this project, the investigators chose to allow patients to complete interviews over the phone. Interactions by phone (rather than in-person visits) can allow for patients who are being discharged from the hospital or have no time to complete the interview during a clinic visit.
The investigators will also conduct a follow up phone call 3 months post-hospitalization during which the investigators will collect mood and anxiety data from participants. The purpose of this data will be to better characterize the population, allowing the investigators to better customize the intervention for this population.
There are two study visits (the first of which can be broken into two parts if the participant cannot complete the interview in the hospital after consenting to the study). The first visit will consist of three brief scales of mood and anxiety (Hospital Anxiety and Depression Scale, Positive and Negative Affect Schedule, and Life Orientation Test-Revised) that will take 10 minutes, followed by a 45 minute interview. Participants also will report their race and ethnicity. The second visit will take place 3 months after the initial visit and will be conducted over the phone. This second visit will consist of the same three brief scales of mood and anxiety.
Baseline Data: Baseline information about enrolled subjects will also be obtained from the patients, care providers, the structured assessments of mood and anxiety symptoms as above, and the electronic medical record as required for characterization of our population. This information will include data regarding medical history (history of cardiac illness, diabetes mellitus, hyperlipidemia, and current smoking), current medical variables (admission diagnosis if applicable, HbA1c), medications, length of hospital stay if applicable, and sociodemographic data (age, gender, race/ethnicity, living alone). This information will help the investigators to ensure that the population the investigators recruit is a representative population of patients with type 2 DM.
Qualitative Data: Subjects will undergo an open-ended, one-hour structured interview. The interview will be performed by study staff trained in qualitative research methods by the study PI, Dr. Huffman, using frameworks from Dr. Huffman's prior work. First, subjects will be asked open-ended questions about positive emotional/cognitive experiences. Interviewers will ask about subjects' experience with positive thoughts and feelings recently, and will attempt to elicit both the frequency/intensity of such experiences and the range of such states (e.g., elation vs. optimism). Next, subjects will be asked in an open-ended manner about ideas that they may have to increase the frequency and breadth of their own positive experiences, and then will be asked their opinion about the potential utility of several different existing positive psychology exercises. The interviewers will then inquire about the impact that positive thoughts/feelings may have on our specific diabetes-related health behaviors of interest.
Follow-up 3 Month Phone Call: Three months after discharge from the hospital, a study RA will call subjects to repeat the measures of mood and anxiety completed at baseline (HADS, PANAS, and LOT-R). The investigators will record specific times at enrollment that subjects would prefer to be called (and not to be called) to reduce intrusion on subjects' lives. The investigators will also remind subjects of their upcoming call, in case they need to reschedule. If subjects would rather complete the questions in written form rather than over the phone, the investigators will send them a written packet at the time of each follow-up.
- Conditions
- Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Qualitative Interviews | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative data
Themes related to: Positive psychological states, barriers to health behaviors, relationships between positive states and barriers to health behaviors, and feedback about potential PP exercises
Measured: Baseline
Secondary outcomes (4)
Change in anxiety
Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline, 3 months
Change in depression
Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline, 3 months
Change in positive affective
Measured by the Positive and Negative Affect Schedule (PANAS)
Measured: Baseline, 3 months
Change in optimism
Measured by the Life Orientation Test-Revised (LOT-R)
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Mar 2015
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 31 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099928
- Sponsor's protocol ID
- 2014P002578
- Status last verified
- May 2017
- First submitted
- 29 Mar 2017
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Positive Psychology Intervention to Improve Health Behaviors in Type 2 Diabetes: Qualitative Research
- ClinicalTrials.gov ID
- NCT03099928
- Acronym / sponsor ID
- 2014P002578
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 4 Apr 2017 (actual)
- 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.
Specific Aim #1 (Qualitative Research): To identify, through qualitative research, deficits in positive affect and associated barriers to completing health behaviors in type 2 DM patients.
Hypothesis: Patients will be able to complete the structured interview, providing information about their own positive emotional states, identifying strategies to enhance positive emotions, linking the presence of positive emotions to better adherence to health-related behaviors, and identifying additional barriers to completing such behaviors.
Specific Aim #2 (Creation of intervention): To use the data gathered from qualitative and quantitative measures to create a positive psychology-based intervention
Hypothesis: Using the information provided in this trial, the investigators will be able to create an intervention, composed of several positive psychology exercises, that is well-matched with a diabetic population and is targeted to the enhancement adherence to health-related behaviors in this population. This intervention will then be ready for next stage testing.
Detailed description
The investigators are proposing to enroll 31 patients with type 2 DM following an outpatient visit to the MGH Diabetes Center or during admission to Ellison 9-11 inpatient units (or sometime in the following 14 days if the participant is not available to complete the interview after consenting for the study).
For these interviews, the investigators will discuss positive emotional states that patients have experienced and talk about ways they might increase these states. The investigators will also touch on health behaviors in which the patient has engaged and whether positive emotions played a role in completing these behaviors. To enhance the accessibility of this project, the investigators chose to allow patients to complete interviews over the phone. Interactions by phone (rather than in-person visits) can allow for patients who are being discharged from the hospital or have no time to complete the interview during a clinic visit.
The investigators will also conduct a follow up phone call 3 months post-hospitalization during which the investigators will collect mood and anxiety data from participants. The purpose of this data will be to better characterize the population, allowing the investigators to better customize the intervention for this population.
There are two study visits (the first of which can be broken into two parts if the participant cannot complete the interview in the hospital after consenting to the study). The first visit will consist of three brief scales of mood and anxiety (Hospital Anxiety and Depression Scale, Positive and Negative Affect Schedule, and Life Orientation Test-Revised) that will take 10 minutes, followed by a 45 minute interview. Participants also will report their race and ethnicity. The second visit will take place 3 months after the initial visit and will be conducted over the phone. This second visit will consist of the same three brief scales of mood and anxiety.
Baseline Data: Baseline information about enrolled subjects will also be obtained from the patients, care providers, the structured assessments of mood and anxiety symptoms as above, and the electronic medical record as required for characterization of our population. This information will include data regarding medical history (history of cardiac illness, diabetes mellitus, hyperlipidemia, and current smoking), current medical variables (admission diagnosis if applicable, HbA1c), medications, length of hospital stay if applicable, and sociodemographic data (age, gender, race/ethnicity, living alone). This information will help the investigators to ensure that the population the investigators recruit is a representative population of patients with type 2 DM.
Qualitative Data: Subjects will undergo an open-ended, one-hour structured interview. The interview will be performed by study staff trained in qualitative research methods by the study PI, Dr. Huffman, using frameworks from Dr. Huffman's prior work. First, subjects will be asked open-ended questions about positive emotional/cognitive experiences. Interviewers will ask about subjects' experience with positive thoughts and feelings recently, and will attempt to elicit both the frequency/intensity of such experiences and the range of such states (e.g., elation vs. optimism). Next, subjects will be asked in an open-ended manner about ideas that they may have to increase the frequency and breadth of their own positive experiences, and then will be asked their opinion about the potential utility of several different existing positive psychology exercises. The interviewers will then inquire about the impact that positive thoughts/feelings may have on our specific diabetes-related health behaviors of interest.
Follow-up 3 Month Phone Call: Three months after discharge from the hospital, a study RA will call subjects to repeat the measures of mood and anxiety completed at baseline (HADS, PANAS, and LOT-R). The investigators will record specific times at enrollment that subjects would prefer to be called (and not to be called) to reduce intrusion on subjects' lives. The investigators will also remind subjects of their upcoming call, in case they need to reschedule. If subjects would rather complete the questions in written form rather than over the phone, the investigators will send them a written packet at the time of each follow-up.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qualitative Interviews | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetes patients admitted to three inpatient units or seen at the MGH Diabetes Center.
Key inclusion criteria (2 listed)
- Adult patients (21 years and older) admitted to one of the inpatient cardiac units (Ellison 9, 10, or11) at MGH or a current outpatient in the MGH Diabetes Center. Patients must have Type 2 Diabetes (confirmed via medical record and diabetologist/attending physician).
- Suboptimal adherence to health behaviors (diabetic diet, physical activity, medication), as measured by the Medical Outcomes Study Specific Adherence Scale (MOS SAS), as denoted by a score of <15 out of 18.
Key exclusion criteria (3 listed)
- Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically-ill patients in research studies.24-26
- Medical conditions precluding interviews, determined in consultation with attending physician or diabetologist.
- Inability to communicate in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative data
Time frame: Baseline
Themes related to: Positive psychological states, barriers to health behaviors, relationships between positive states and barriers to health behaviors, and feedback about potential PP exercises
4 secondary outcomes
Change in anxiety
Time frame: Baseline, 3 months
Change in depression
Time frame: Baseline, 3 months
Change in positive affective
Time frame: Baseline, 3 months
Change in optimism
Time frame: Baseline, 3 months
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 16 May 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Massachusetts General Hospital.
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 2 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 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Qualitative data (time frame: Baseline). 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 16 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.