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Positive Psychology for Type 2 Diabetes (BEHOLD Trial)
N/A
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of Type 2 Diabetes
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Awards & highlights
BEHOLD Trial Summary
This trialtests if an 8-week, remote, positive-psychology-motivational intervention helps people with type 2 diabetes be more physically active.
Who is the study for?
This trial is for individuals with Type 2 Diabetes who are not very active (less than 150 minutes of exercise per week). It's not suitable for those with severe heart disease, life-threatening conditions, cognitive issues preventing informed consent, major depression, or language barriers. Participants must be able to receive texts and not be in another well-being program.Check my eligibility
What is being tested?
The study tests an 8-week positive psychology and motivational interviewing intervention via remote delivery plus text messages over a total of 16 weeks. This approach is compared against motivational interviewing alone in people with low physical activity levels.See study design
What are the potential side effects?
Since the interventions involve psychological support and communication rather than medication, typical medical side effects are not expected. However, participants may experience emotional discomfort or stress during the process.
BEHOLD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Type 2 Diabetes.
BEHOLD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 16 weeks
Secondary outcome measures
Change from Baseline Overall Activity at 16 weeks
Change from Baseline in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items) at 16 weeks
Other outcome measures
Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 8, 24, and 52 weeks
Change from Baseline Overall Activity at 8, 24, and 52 weeks
Change from Baseline in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items) at 8, 24, and 52 weeks
+22 moreBEHOLD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Positive Psychology + Motivational InterviewingExperimental Treatment1 Intervention
Each week, participants in the PP-MI intervention group will complete a PP activity and work towards a physical activity goal, then complete a phone session with a study trainer. Each phone session will include PP and goal setting portions. In the PP portion, the study trainer will (a) review the week's PP exercise, (b) discuss the rationale of the next week's PP exercise through a guided review of the PP-MI manual, and (c) assign the next week's PP exercise. In the goal-setting portion, the trainer will (a) review the participant's physical activity goal from the prior week, (b) discuss techniques for improving physical activity (e.g. tracking activity), and (c) help the participant to set a physical activity goal for the next week. Participants also will receive supplemental text messages throughout the 8 weeks of the intervention and during the initial follow-up period (Week 9-16).
Group II: Motivational InterviewingActive Control1 Intervention
Each week, participants in the MI-alone group will complete an activity related to a health behavior (e.g., thinking about the pros and cons of changing the behavior), then complete a phone session with a study trainer. During the phone session, the trainer will (a) review the prior week's topic, (b) discuss techniques for improving adherence to health behaviors (e.g. tracking activity), and (c) problem-solve barriers and encourage the use of resources. Participants also will receive supplemental text messages throughout the 8 weeks of the intervention and during the initial follow-up period (Week 9-16).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positive Psychology + Motivational Interviewing
2017
N/A
~200
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,201 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a score of 15 or higher on the Patient Health Questionnaire-9 (PHQ-9), indicating moderate to severe depression.I have been diagnosed with Type 2 Diabetes.You don't exercise much, less than 2.5 hours of moderate to vigorous activity per week.I am able to understand and make decisions about my health care.I have been diagnosed with coronary artery disease.I use insulin that is not long-acting.You are currently involved in another program that focuses on improving health or staying active.I cannot be physically active due to another health issue.You have a medical condition that is likely to cause death within 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Motivational Interviewing
- Group 2: Positive Psychology + Motivational Interviewing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for individuals to participate in this research endeavor?
"That is correct. According to clinicaltrials.gov, this research initiative was initially unveiled on October 12th 2022 and has recently been revised as of January 30th 2023. The trial requires 280 participants from one medical centre."
Answered by AI
How many participants are being monitored in this medical experiment?
"Affirmative. Clinicaltrials.gov states that this clinical trial, posted on October 12th 2022, is still recruiting patients to the study. A total of 280 participants are needed from one site for enrolment in this investigation."
Answered by AI
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