Precision Mental Health in Diabetes - Subtypes of Mental Health, Trajectories, and Patterns With Glycaemic Control

Diabetes Mellitus Clinical Trial

— PRO-MENTAL  

Official title:

PRO-MENTAL: Precision Mental Health in Diabetes - Subtypes of Mental Health, Trajectories, and Patterns With Glycaemic Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05548699
• Other study ID #: HermannsNorbert2022-07-14VADM
• Status: Recruiting
• Start date: May 2, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Forschungsinstitut der Diabetes Akademie Mergentheim
• Contact: Norbert Hermanns, Prof, PhD
• Phone: +49 7931 9619253
• Email: hermanns[@]fidam.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

PRO-MENTAL is a non-interventional, prospective, observational study investigating longitudinal associations between diabetes distress, mental disorders, and glycemic outcomes in people with type 1 diabetes (T1D) and type 2 diabetes (T2D). The study aims to determine mental health subtypes, trajectories, and patterns and to advance a precision medicine approach to improve mental health in people with diabetes through personalized care and interventions.

A total of 1500 people with T1D or T2D will participate in the study, running over a 24-month period. Participants will be recruited at different levels of diabetes care including specialized centers and hospitals. The assessment includes a baseline assessment (clinical interview, questionnaire survey, and laboratory assessment) and four subsequent measurement time points - every six months - to a total period of two years. Each measurement time point includes an online questionnaire survey as well as a 14-day ambulatory assessment of daily mental and somatic variables (smartphone-based ecological momentary assessment (EMA) of daily sleep quality, mood, stress, and diabetes-related burdens/distress, as well as continuous glucose measurement (CGM) of daily glucose levels).

The study uses precision monitoring to identify evidence-based subgroups of people with diabetes with regard to mental disorders/problems and glycemic outcome. Epidemiological data regarding prevalence and incidence rates of depression, anxiety, and eating disorders will be analyzed, and patient trajectories and patterns will be determined. The study also aims to shed more light on the mediating mechanisms between mental health and glycemic outcomes.

The findings of the study will be used as the basis to develop a precision medicine approach with personalized interventions for specific sub-groups of people with type 1 and type 2 diabetes.

Description:

Comorbid mental disorders as well as mental symptoms are common in people with type 1 diabetes (T1D) and type 2 diabetes (T2D). Depression, anxiety, and eating problems are particularly prevalent, and diabetes-related distress may contribute to or interact with mental disorders. Furthermore, while the management of diabetes aims to achieve near-normal glucose levels to prevent health decline and complications, glycemic outcomes may be impaired in people with significant mental comorbidity.

The objective of the PRO-MENTAL study is to use precision monitoring to identify evidence-based subgroups of people with diabetes with regard to mental disorders/problems and glycemic outcomes, to determine typical patterns and derive patient trajectories for informing a precision medicine approach offering personalized interventions for people with T1D and T2D. Precision monitoring uses continuous glucose monitoring (CGM) and ecological momentary assessment (EMA) methods as well as patient-reported outcomes (PRO) according to self-report scales and interviews.

Another aim is to answer epidemiological questions regarding depressive, anxiety and eating disorders in people with T1D and T2D (including assessment of bipolar disorders for differential diagnosis). In addition to clinical disorders, subclinical (=elevated) mental symptoms (e.g., depressive symptoms) and diabetes-related distress will be investigated as adverse factors in diabetes.

The findings of the study will serve as the basis for developing a precision medicine approach with personalized interventions for specific subgroups of people with T1D and T2D and mental comorbidity.

The primary research question refers to prospective associations of psychological disturbances/problems, especially depressive symptoms, anxiety symptoms, diabetes distress, and eating disorder symptoms, with self-management/health behaviors and glycemic outcomes. Using diagnostic interviews assessing affective, anxiety, and eating disorders and the collection of behavioral, somatic and psychological variables using questionnaires and surveys, subgroups and trajectories will be identified. In longitudinal analyses, the prognostic and moderating contribution of these parameters to the prediction of glycemic and mental health outcomes will be investigated.

Secondary objectives of the study are to identify predictors and/or moderators that may explain the incidence and persistence as well as associations between the above mental health variables and diabetes outcomes. For this purpose, measures of health-related quality of life, well-being, sleep quality, hypoglycemic anxiety, fear of sequelae, problems of diabetes treatment, diabetes acceptance, stressful life events, alcohol misuse, social support, COVID-19-related burden, and psychological resilience are also collected.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 75 years

• Diagnosis of type 1 diabetes (T1D) or type 2 diabetes (T2D)

• Diabetes duration = 1 year

• Sufficient German language skills

• Written informed consent

Exclusion Criteria:

• Inability to consent,

• Significant cognitive impairment (e.g., cognitive disorder, dementia)

• Severe somatic disease or mental disorder likely to impede study participation or confound results (e.g., severe heart failure = NYHA III; cancer requiring treatment; dialysis-dependent nephropathy; schizophrenia/psychotic disorder)

• Terminal illness

• Being bedridden

Related Conditions & MeSH terms

• Anxiety and Fear
• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Symptoms
• Diabetes Mellitus
• Eating Behavior
• Eating Disorder Symptom
• Eating Disorders
• Emotional Distress
• Feeding and Eating Disorders
• Hyperglycemia

Locations

Country	Name	City	State
Germany	Diabetes Center Mergentheim	Bad Mergentheim	Baden-Württemberg
Germany	Diabetes Practice Mergentheim	Bad Mergentheim	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Forschungsinstitut der Diabetes Akademie Mergentheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	COVID-19-related burden	COVID-19-related burden is assessed as control variable at baseline, 12-month FU, and 24-month FU with items from the previous DIA-LINK studies requesting the burden due to the pandemic (rated on an 11-point scale from 0 - 10).	Baseline, 24-month FU
Other	Psychological resilience	Psychological resilience is assessed as control variable at baseline with the 13-item Resilience Scale (RS-13).	Baseline
Other	Social support	Social support is assessed as control variable at baseline, 12-month FU, and 24-month FU with the 3-item Oslo Social Support Scale (OSSS-3).	Baseline, 24-month FU
Other	Night eating	Night eating behaviors are assessed as control variable at baseline, 12-month FU, and 24-month FU with the Night Eating Questionnaire (NEQ).	Baseline, 24-month FU
Other	Stressful life events	Stressful life events during the past 12 months are assessed as control variable at baseline, 12-month FU, and 24-month FU using the Life Events Questionnaire (LEQ) (=the German "Fragebogen zu kritischen Lebensereignissen"; reflecting the overall burden due to stressful life events in the past year).	Baseline, 24-month FU
Primary	Prevalence of affective disorders at baseline (per diagnostic interview)	Diagnoses of affective disorders are assessed at baseline using the corresponding section of the Brief Diagnostic Interview for Mental Disorders (Mini-DIPS Open Access).	Baseline
Primary	Prevalence of anxiety disorders at baseline (per diagnostic interview)	Diagnoses of anxiety disorders are assessed at baseline using the corresponding section of the Brief Diagnostic Interview for Mental Disorders (Mini-DIPS Open Access).	Baseline
Primary	Prevalence of eating disorders at baseline (per diagnostic interview)	Diagnoses of eating disorders are assessed at baseline using the corresponding section of the Brief Diagnostic Interview for Mental Disorders (Mini-DIPS Open Access).	Baseline
Primary	Depressive symptoms: incidence at 24-month FU	Depressive symptoms are assessed with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU. Primary outcome is the incidence of depressive symptoms at 24-month FU compared to baseline.	Baseline, 24-month FU
Primary	Depressive symptoms: recovery at 24-month FU	Depressive symptoms are assessed with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU. Primary outcome is the recovery from depressive symptoms at 24-month FU compared to baseline.	Baseline, 24-month FU
Primary	Anxiety symptoms: incidence at 24-month FU	Anxiety symptoms are assessed with the Generalized Anxiety Disorders-7 (GAD-7) Questionnaire at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month. Primary outcome is the incidence of anxiety symptoms at 24-month FU compared to baseline.	Baseline, 24-month FU
Primary	Anxiety symptoms: recovery	Anxiety symptoms are assessed with the Generalized Anxiety Disorders-7 (GAD-7) Questionnaire at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU. Primary outcome is the recovery from anxiety symptoms at 24-month FU compared to baseline.	Baseline, 24-month FU
Primary	Diabetes distress over time	Diabetes distress is assessed with the Problem Areas in Diabetes Scale (PAID) at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU to detect changes in diabetes distress from baseline to 24-month FU.	Baseline, 24-month FU
Primary	Daily diabetes burdens over time	Daily diabetes burdens (daily diabetes distress) are assessed at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU over each 14 consecutive days using smartphone-based ecological momentary assessment with selected items of the Problem Areas in Diabetes Scale (PAID) adapted for daily assessment (rated on an 11-point scale from 0 - 10) to detect changes in daily burdens from baseline to 24-month FU.	Baseline, 24-month FU
Primary	Eating problems: incidence	Eating problems (=disordered eating behavior/eating disorder symptoms) are assessed with the Diabetes Eating Problems Survey-Revised (DEPS-R; a validated, self-report measure for eating problems of people with diabetes where generic eating disorder questionnaires yield significant false-positive rates due to specific eating behaviors and dietary requirements for diabetes) at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU. Primary outcome is the incidence of eating problems at 24-month FU compared to baseline.	Baseline, 24-month FU
Primary	Glycated hemoglobin (HbA1c) over time	HbA1c (glycated hemoglobin), a laboratory measure of average blood glucose over the past 8 to 12 weeks, is estimated/collected at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU from the participants to detect changes for glycated hemoglobin from baseline to 24-month FU.	Baseline, 24-month FU
Primary	Glycemic levels (CGM glucose) over time	In addition to the global parameter HbA1c, automatically recorded daily glucose values are obtained from participants where continuous glucose monitoring (CGM) devices are used. Available glucose data are extracted at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU for each over 14 consecutive days of CGM measurement - parallel to the daily EMA - to detect changes in glucose levels from baseline to 24-month FU.	Baseline, 24-month FU
Primary	Daily stress levels over time	Daily stress levels are assessed at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU over each 14 consecutive days using smartphone-based ecological momentary assessment with items from the previous DIA-LINK study (requesting the current stress level and specific stressors, rated on an 11-point scale from 0 - 10) to detect changes in daily stress levels from baseline to 24-month FU.	Baseline, 24-month FU
Secondary	General health state over time	The self-evaluated general self-rated health state is assessed at baseline, 12-month FU, and 24-month FU using the 8-item Short Form Health Survey (SF-8) to detect changes in the health state from baseline to 24-month FU.	Baseline, 24-month FU
Secondary	Subjective health over time	The subjective health state is assessed at baseline, 12-month FU, and 24-month FU using the visual analogue scale (VAS) of the EuroQol Five Dimensions Questionnaire (EQ-5D) to detect changes in subjective health from baseline to 24-month FU.	Baseline, 24-month FU
Secondary	Wellbeing over time	Wellbeing is assessed at baseline, 12-month FU, and 24-month FU using the WHO-Five Well-being Index (WHO-5) to detect changes in wellbeing from baseline to 24-month FU.	Baseline, 24-month FU
Secondary	General sleep quality over time	General sleep quality assessed at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU using items of the Pittsburgh Sleep Quality Index (PSQI) to detect changes in sleep quality from baseline to 24-month FU.	Baseline, 24-month FU
Secondary	Daily sleep quality over time	Daily sleep quality assessed at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU over each 14 days using smartphone-based ecological momentary assessment with selected PSQI items adapted for daily assessment (rated on an 11-point scale from 0 - 10) to detect changes in daily sleep quality from baseline to 24-month FU.	Baseline, 24-month FU
Secondary	Fear of diabetes complications over time	Fear of diabetes complications is assessed at baseline, 12-month FU, and 24-month FU with the short form of the Fear of Diabetes Complications Questionnaire (FDCQ; requesting frequencies of worries and fears regarding long-term complications of diabetes) to detect changes in fear levels from baseline to 24-month FU.	Baseline, 24-month FU
Secondary	Fear of hypoglycemia over time	Fear of hypoglycemia is assessed at baseline, 12-month FU, and 24-month FU with the short form of the Hypoglycemia Fear Survey II (HFS-II-SF; requesting hypoglycemia-related worries and avoidance behaviors) to detect changes in fear levels from baseline to 24-month FU.	Baseline, 24-month FU
Secondary	Diabetes acceptance over time	Diabetes acceptance is assessed at baseline, 12-month FU, and 24-month FU with a short form of the Diabetes Acceptance Scale (DAS) to detect changes in diabetes acceptance from baseline to 24-month FU.	Baseline, 24-month FU
Secondary	Daily eating problems over time	Eating problems in daily life are assessed at baseline, 6-month FU, 12-month FU, 18-month FU, and 24-month FU over each 14 consecutive days using smartphone-based ecological momentary assessment with items requesting specific problematic eating behaviors (rated on an 11-point scale from 0 - 10) to detect changes in daily eating problems from baseline to 24-month FU.	Baseline, 24-month FU
Secondary	Diabetes self-management over time	Diabetes self-management behaviors are assessed at baseline, 12-month FU, and 24-month FU with the revised Diabetes Self-Management Questionnaire-Revised (DSMQ-R) to detect changes in diabetes self-management from baseline to 24-month FU.	Baseline, 24-month FU
Secondary	Alcohol misuse over time	Alcohol abuse/misuse is assessed at baseline, 12-month FU, and 24-month FU using the 5-item alcohol module of the Patient Health Questionnaire (PHQ-D) to detect changes in alcohol use from baseline to 24-month FU.	Baseline, 24-month FU