Type 2 DiabetesBEHOLDNCT02736084
Boosting Emotions & Happiness in Outpatients Living With Diabetes
A study testing Positive Psychology in people with Type 2 Diabetes, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators developed a novel, telephone-based, 12-week positive psychology intervention and will assess its feasibility and short-term impact in adults with type 2 diabetes (T2D) and suboptimal health behavior adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Positive Psychology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jul 2014
- 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
- Current patient of the MGH Diabetes Center or inpatient on Ellison 9-11, White 8-11, Ellison 16, or Bigelow 11
- Diagnosis of type 2 Diabetes (confirmed via medical record and patient's treatment provider)
- Age 18 and older
- Able to read/write in English
- Suboptimal adherence, defined as a score of 15 or less on three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items related to adherence to medications, diet, and exercise.
Who cannot join
- Cognitive disorder precluding informed consent or meaningful participation in the PP exercises, assessed using a six-item cognitive screen developed for research.
- Lack of telephone access
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Positive Psychology Program for Patients With Type 2 Diabetes: A Pilot Study
The investigators developed a novel, telephone-based, 12-week positive psychology intervention and will assess its feasibility and short-term impact in adults with type 2 diabetes (T2D) and suboptimal health behavior adherence. Participants will receive a positive psychology (PP) manual, complete exercises (e.g., writing a gratitude letter, performing acts of kindness), and review these activities by phone with a study trainer over the 12-week study period.
Specific Aim #1 (Feasibility and acceptability (immediate impact); primary aim): To assess whether PP exercises administered over the phone are feasible and linked with immediate benefit in patients with T2D, as measured by ratings provided pre- and post- each exercise.
Read more
Hypothesis: The PP exercises will be feasible (i.e., 4 of the 7 PP exercises will be completed by a majority of participants, and participants will have a mean score of at least 7 out of 10 on ratings of ease of completion for the exercises. The PP exercises will also have adequate immediate impact (i.e., mean ratings of 7/10 of exercise utility post-exercise and ratings of optimism post-exercise that are significantly higher than pre-exercise).
Specific Aim #2 (Changes in clinical outcome measures): To determine whether the PP intervention is linked to improvements in psychological well-being, during and after the intervention period (6 \& 12 weeks), via measures of optimism, gratitude, depression, and anxiety. To examine whether the brief PP intervention is associated with improvements in self-reported outcomes related to health (diabetes self-care, diabetes distress, health related quality of life), during and after the intervention.
Hypothesis: Participants will have higher mean scores on all psychological outcome measures at 6 and 12 weeks compared to baseline. Participants will also have higher mean scores on all health-related outcome measures at 6 and 12 weeks compared to baseline.
Read the detailed description
This is a pilot and feasibility study in adult inpatients and outpatients at MGH. Participants will have Type 2 Diabetes (T2D) and are required to report suboptimal adherence to health behaviors, measured by the Medical Outcomes Study Specific Adherence Scale (MOS SAS). All participants will receive a 12-week PP intervention and pre- and post-intervention assessments of mood and physical symptoms.
Participants will be enrolled from the outpatient Diabetes Center and inpatient medical units of MGH; research staff will introduce the study, assess for inclusion and exclusion criteria, and obtain written informed consent. Post-enrollment, and prior to initiation of the intervention, participants will complete baseline self-report measures of clinical outcomes.
During the initial enrollment visit, participants will receive a treatment manual. In person or by telephone, the study interventionist will review the introductory portion of the manual and discuss the first exercise (Gratitude for Positive Events) with the participant. In subsequent weeks, exercises will be completed independently by participants, recorded in their treatment manual, and then discussed over the phone with their trainer. In the final week, after the final exercise is reviewed, the interventionist and participant will discuss future implementation and ways to incorporate the principles into daily life.
The 12-week intervention will consist of 7 distinct PP exercises, to be completed weekly for the first 4 weeks and then biweekly over the next 8 weeks.
For feasibility, interventionists will record rates of exercise completion at each participant phone session. For acceptability, participants will rate their optimism and positive affect on a 0-10 scale prior to completing the exercise and then immediately following the exercise. Additionally, participants will also rate the ease and overall utility of the exercise on a 0-10 scale after each exercise.
At baseline, 6 weeks, and 12 weeks, non-interventionist study staff obtained the following validated measures of study outcomes:
- Optimism = Life Orientation Test-Revised (LOT-R)
- Gratitude = Gratitude Questionnaire-6 (GQ-6)
- Anxiety and depression = Hospital Anxiety and Depression Scale (HADS)
- Diabetes-related distress = Diabetes Distress Scale (DDS)
- Health-related quality of life and function = Patient-Reported Outcomes Measurement Information System physical function scale (PROMIS-PF-10)
- Diabetes self-care behaviors = Summary of Diabetes Self-Care Activities Measure (SDSCA)
- Health behavior adherence = Medical Outcomes Study Specific Adherence Scale (MOS SAS)
- Conditions
- Type 2 Diabetes
- Being tested
- Positive Psychology
- Keywords
- optimism, positive affect, adherence, health behavior, diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Health Behavior, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive PsychologyBehavioural
The Positive Psychology intervention consists of 7 exercises that will be completed by the participant with the guidance of a trainer.
| Study group | Role | What they receive |
|---|---|---|
| Positive Psychology | Experimental | The Positive Psychology intervention consists of 7 exercises that will be completed by the participant with the guidance of a trainer.
Exercises:
Gratitude for positive events Using personal strengths Gratitude letter Enjoyable and meaningful activities Recalling past success Performing acts of kindness Repeating one of the previous exercises. Receives: Behavioral: Positive Psychology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility
Rate of intervention feasibility will be measured by the number of exercises completed by each participant. After the exercise, participants will rate the ease of the exercise on a 0-10 Likert scale. Feasibility will be defined as: 4 of the 7 PP exercises will be completed by a majority of patients and subjects will have a mean score of at least 3.5 out of 5 on ratings of ease of completion for the exercises.
Measured: 10 Weeks
Intervention Acceptability
To assess acceptability (and immediate impact), participants will rate their optimism and positive affect on a 0-10 Likert scale prior to completing the exercise and then immediately following the exercise. Adequate immediate impact will be defined as: mean ratings of 3.5/5 of exercise utility post-exercise and ratings of optimism post-exercise that are significantly higher than pre-exercise.
Measured: 10 weeks
Secondary outcomes (7)
Change in LOT-R Scores
The Life Orientation Test-Revised (LOT-R) is a validated, six item, self-report measure of optimism.
Measured: 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.
Measured: Baseline, 6 weeks, and 12 weeks
Change in HADS Scores
The Hospital Anxiety and Depression Scale is a validated 14-item measure designed for medically ill patients and has few somatic symptom items.
Measured: Baseline, 6 weeks, and 12 weeks
Change in DDS Scores
The 17-item Diabetes Distress Scale is a validated scale for use specifically in patients with diabetes
Measured: Baseline, 6 weeks, and 12 weeks
Changes in PROMIS-PF-10 Scores
The Patient-Reported Outcomes Measurement Information System physical function scale is an NIH-supported 10-item scale used to asses health-related quality of life and function
Measured: Baseline, 6 weeks, and 12 weeks
Changes in SDSCA Scores
11 items from Summary of Diabetes Self-Care Activities Measure Diabetes are used to measure self-care behaviors. Behaviors measured will be diet, physical activity, blood sugar monitoring, and foot care.
Measured: Baseline, 6 weeks, and 12 weeks
Changes in MOS SAS Scores
Three Medical Outcomes Study Specific Adherence Scale items assessing medication, diet, and exercise, will be measured individually and as a composite score.
Measured: Baseline, 6 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startAug 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT02736084
- Sponsor's protocol ID
- 2013P001602
- Acronym
- BEHOLD
- Status last verified
- Apr 2016
- First submitted
- 30 Mar 2016
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
DuBois CM, Millstein RA, Celano CM, Wexler DJ, Huffman JC. Feasibility and Acceptability of a Positive Psychological Intervention for Patients With Type 2 Diabetes. Prim Care Companion CNS Disord. 2016 May 5;18(3):10.4088/PCC.15m01902. doi: 10.4088/PCC.15m01902. eCollection 2016.
PubMed 27733954
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Positive Psychology Program for Patients With Type 2 Diabetes: A Pilot Study
- ClinicalTrials.gov ID
- NCT02736084
- Acronym / sponsor ID
- BEHOLD / 2013P001602
- Conditions
- Type 2 Diabetes
- Keywords
- optimism, positive affect, adherence, health behavior, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Apr 2016 (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 developed a novel, telephone-based, 12-week positive psychology intervention and will assess its feasibility and short-term impact in adults with type 2 diabetes (T2D) and suboptimal health behavior adherence. Participants will receive a positive psychology (PP) manual, complete exercises (e.g., writing a gratitude letter, performing acts of kindness), and review these activities by phone with a study trainer over the 12-week study period.
Specific Aim #1 (Feasibility and acceptability (immediate impact); primary aim): To assess whether PP exercises administered over the phone are feasible and linked with immediate benefit in patients with T2D, as measured by ratings provided pre- and post- each exercise.
Hypothesis: The PP exercises will be feasible (i.e., 4 of the 7 PP exercises will be completed by a majority of participants, and participants will have a mean score of at least 7 out of 10 on ratings of ease of completion for the exercises. The PP exercises will also have adequate immediate impact (i.e., mean ratings of 7/10 of exercise utility post-exercise and ratings of optimism post-exercise that are significantly higher than pre-exercise).
Specific Aim #2 (Changes in clinical outcome measures): To determine whether the PP intervention is linked to improvements in psychological well-being, during and after the intervention period (6 \& 12 weeks), via measures of optimism, gratitude, depression, and anxiety. To examine whether the brief PP intervention is associated with improvements in self-reported outcomes related to health (diabetes self-care, diabetes distress, health related quality of life), during and after the intervention.
Hypothesis: Participants will have higher mean scores on all psychological outcome measures at 6 and 12 weeks compared to baseline. Participants will also have higher mean scores on all health-related outcome measures at 6 and 12 weeks compared to baseline.
Detailed description
This is a pilot and feasibility study in adult inpatients and outpatients at MGH. Participants will have Type 2 Diabetes (T2D) and are required to report suboptimal adherence to health behaviors, measured by the Medical Outcomes Study Specific Adherence Scale (MOS SAS). All participants will receive a 12-week PP intervention and pre- and post-intervention assessments of mood and physical symptoms.
Participants will be enrolled from the outpatient Diabetes Center and inpatient medical units of MGH; research staff will introduce the study, assess for inclusion and exclusion criteria, and obtain written informed consent. Post-enrollment, and prior to initiation of the intervention, participants will complete baseline self-report measures of clinical outcomes.
During the initial enrollment visit, participants will receive a treatment manual. In person or by telephone, the study interventionist will review the introductory portion of the manual and discuss the first exercise (Gratitude for Positive Events) with the participant. In subsequent weeks, exercises will be completed independently by participants, recorded in their treatment manual, and then discussed over the phone with their trainer. In the final week, after the final exercise is reviewed, the interventionist and participant will discuss future implementation and ways to incorporate the principles into daily life.
The 12-week intervention will consist of 7 distinct PP exercises, to be completed weekly for the first 4 weeks and then biweekly over the next 8 weeks.
For feasibility, interventionists will record rates of exercise completion at each participant phone session. For acceptability, participants will rate their optimism and positive affect on a 0-10 scale prior to completing the exercise and then immediately following the exercise. Additionally, participants will also rate the ease and overall utility of the exercise on a 0-10 scale after each exercise.
At baseline, 6 weeks, and 12 weeks, non-interventionist study staff obtained the following validated measures of study outcomes:
- Optimism = Life Orientation Test-Revised (LOT-R)
- Gratitude = Gratitude Questionnaire-6 (GQ-6)
- Anxiety and depression = Hospital Anxiety and Depression Scale (HADS)
- Diabetes-related distress = Diabetes Distress Scale (DDS)
- Health-related quality of life and function = Patient-Reported Outcomes Measurement Information System physical function scale (PROMIS-PF-10)
- Diabetes self-care behaviors = Summary of Diabetes Self-Care Activities Measure (SDSCA)
- Health behavior adherence = Medical Outcomes Study Specific Adherence Scale (MOS SAS)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positive Psychology | Experimental | Behavioral: Positive PsychologyThe Positive Psychology intervention consists of 7 exercises that will be completed by the participant with the guidance of a trainer. Exercises: Gratitude for positive events Using personal strengths Gratitude letter Enjoyable and meaningful activities Recalling past success Performing acts of kindness Repeating one of the previous exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current patient of the MGH Diabetes Center or inpatient on Ellison 9-11, White 8-11, Ellison 16, or Bigelow 11
- Diagnosis of type 2 Diabetes (confirmed via medical record and patient's treatment provider)
- Age 18 and older
- Able to read/write in English
- Suboptimal adherence, defined as a score of 15 or less on three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items related to adherence to medications, diet, and exercise.
Key exclusion criteria (2 listed)
- Cognitive disorder precluding informed consent or meaningful participation in the PP exercises, assessed using a six-item cognitive screen developed for research.
- Lack of telephone access
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 PsychologyThe Positive Psychology intervention consists of 7 exercises that will be completed by the participant with the guidance of a trainer. | Behavioural | Positive Psychology |
Primary outcome
Intervention Feasibility
Time frame: 10 Weeks
Rate of intervention feasibility will be measured by the number of exercises completed by each participant. After the exercise, participants will rate the ease of the exercise on a 0-10 Likert scale. Feasibility will be defined as: 4 of the 7 PP exercises will be completed by a majority of patients and subjects will have a mean score of at least 3.5 out of 5 on ratings of ease of completion for the exercises.
Intervention Acceptability
Time frame: 10 weeks
To assess acceptability (and immediate impact), participants will rate their optimism and positive affect on a 0-10 Likert scale prior to completing the exercise and then immediately following the exercise. Adequate immediate impact will be defined as: mean ratings of 3.5/5 of exercise utility post-exercise and ratings of optimism post-exercise that are significantly higher than pre-exercise.
7 secondary outcomes
Change in LOT-R Scores
Time frame: Baseline, 6 weeks, and 12 weeks
Change in GQ-6 Scores
Time frame: Baseline, 6 weeks, and 12 weeks
Change in HADS Scores
Time frame: Baseline, 6 weeks, and 12 weeks
Change in DDS Scores
Time frame: Baseline, 6 weeks, and 12 weeks
Changes in PROMIS-PF-10 Scores
Time frame: Baseline, 6 weeks, and 12 weeks
Changes in SDSCA Scores
Time frame: Baseline, 6 weeks, and 12 weeks
Changes in MOS SAS Scores
Time frame: Baseline, 6 weeks, and 12 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 13 Apr 2016.
- Derived from this study: PubMed 27733954DuBois CM, Millstein RA, Celano CM, Wexler DJ, Huffman JC. Feasibility and Acceptability of a Positive Psychological Intervention for Patients With Type 2 Diabetes. Prim Care Companion CNS Disord. 2016 May 5;18(3):10.4088/PCC.15m01902. doi: 10.4088/PCC.15m01902. eCollection 2016.
- 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.
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 in people with Type 2 Diabetes, 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 5 inclusion and 2 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 13 Apr 2016. 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?
Intervention Feasibility (time frame: 10 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02736084, which also lists 1 linked publication.
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 13 Apr 2016.