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

NCT05548699 | Completed

• 1 other identifier: HermannsNorbert2022-07-14VADM
• Study Type: observational
• Target: 1,290
• Locations: 1 country
• Sites: 2

Brief 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. Note/Update 27.11.2025: The recruitment resulted in a total of 1290 participants enrolled until 31.12.2024 (= study completion date). Yet the recruitment and follow-up of participants is being continued within the ongoing TwinPeaks study (NCT07212075) from 2025-2027.

Conditions

Diabetes Mellitus; Depressive Disorder; Depressive Symptoms; Anxiety Disorders; Anxiety and Fear; Eating Disorders; Eating Disorder Symptom; Eating Behavior; Hyperglycemia; Emotional Distress

Outcome Measures

Primary Outcomes (13)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (11)

• General health state over time

  Baseline, 24-month FU

• Subjective health over time

  Baseline, 24-month FU

• Wellbeing over time

  Baseline, 24-month FU

• General sleep quality over time

  Baseline, 24-month FU

• Daily sleep quality over time

  Baseline, 24-month FU

Other Outcomes (5)

• COVID-19-related burden

  Baseline, 24-month FU

• Psychological resilience

  Baseline

• Social support

  Baseline, 24-month FU

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with Type 1 Diabetes or Type 2 Diabetes

You may qualify if:

• Age between 18 and 80 years
• Diagnosis of type 1 diabetes (T1D) or type 2 diabetes (T2D)
• Diabetes duration ≥ 1 year
• Sufficient German language skills
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Forschungsinstitut der Diabetes Akademie Mergentheim: lead

Study Sites (2)

Diabetes Center Mergentheim

Bad Mergentheim, Baden-Wurttemberg, 97980, Germany

Location

Diabetes Practice Mergentheim

Bad Mergentheim, Baden-Wurttemberg, 97980, Germany

Location

Related Links

• ClinicalTrials entry of the "TwinPeaks" study that has continued the recruitment and follow-up of the PRO-MENTAL cohort since 2025.

MeSH Terms

Conditions

Diabetes Mellitus; Depressive Disorder; Depression; Anxiety Disorders; Feeding and Eating Disorders; Feeding Behavior; Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal

Study Officials

• Norbert Hermanns, Prof, PhD

  Research Institute Diabetes Academy Mergentheim (FIDAM)

  PRINCIPAL INVESTIGATOR

• Bernhard Kulzer, Prof, PhD

  Research Institute Diabetes Academy Mergentheim (FIDAM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. phil.

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 21, 2022
• Study Start: May 2, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

DE (2)