Use of an Online Intervention for the Treatment of Diabetes Distress in Patients With Type 1-Diabetes

NCT06436456 | Recruiting

• 1 other identifier: 22/57849
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate whether an online intervention can be helpful in reducing diabetes distress in people with type 1 diabetes and elevated diabetes distress, compared to individual counselling sessions (online, phone-based or face-to-face, depending on the preference of the person with type 1 diabetes). Half of the participants will receive the online intervention, while the other half will receive individual counseling sessions with a psychologist. Objectives: The main aim of this study is to investigate if the online intervention is feasible and liked by people with type 1 diabetes and diabetes distress, in comparison with individual counselling sessions. Hypotheses: The investigators predict that both interventions will be feasible to use, shown by how many people join, stay engaged, and complete the interventions. The investigators also think that people will find both interventions acceptable, as shown by the positive feedback given in interviews after they finish.

Conditions

Diabetes Mellitus, Type 1; Diabetes Distress

Keywords

Diabetes Mellitus, Type 1; Diabetes distress; Online intervention

Outcome Measures

Primary Outcomes (10)

• The proportion of eligible patients who agree to participate in the interventions throughout the study period

  The number of eligible patients who agree to participate in the interventions

  Throughout the duration of the study approx. 12 months

• The completion rates of survey measures at pre- and post-intervention and at three months follow-up

  The number of patients completing the survey measures at pre- and post-intervention as well as at three months follow-up

  Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention

• Characteristics of patients receiving the interventions and those who drop out assessed through survey data.

  Patient characteristics assessed through survey data

  Throughout study participation, an average of 6 months

• Acceptability of the online intervention expressed by patients

  Will be assess by expressions of patients through qualitative semi structured interviews

  After completion of the intervention, an average of 3-12 months

• Acceptability of the online intervention expressed by participating clinical staff

  Will be assess by expressions of participating clinical staff through qualitative semi structured interviews

  Obtained after study completion approx.12 months

• Number of log ins on the platform

  The number of log ins on the platform by patients in the online intervention

  Obtained after completion of the online intervention, an average of 3-6 months

• Time points of log ins on the platform

  The time points of log ins to the platform by patients in the online intervention during their access to the platform

  Obtained after completion of the online intervention, an average of 3-6 months

• Numbers of hours spend on the platform

  The number of hours the patients in the online intervention spend on the platform during their access to the platform

  Obtained after completion of the online intervention, an average of 3-6 months

• Numbers of modules completed in the online intervention

  The number of modules completed by the patients in the online intervention

  Obtained after completion of the online intervention, an average of 3-6 months

• Number of messages sent between patients and psychologist

  The number of messages sent between the patients in the online intervention and their psychologist

  Obtained after completion of the online intervention, an average of 3-6 months

Secondary Outcomes (10)

• Diabetes Distress Scale for type 1 diabetes (T1 DDS)

  Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention

• Acceptance & Action Diabetes Questionnaire (AADQ-6)

  Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention

• The Patient Activation Measure (PAM)

  Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention

• The DAWN (Diabetes Attitudes, Wishes and Needs study) Impact of Diabetes Profile (DIDP)

  Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention

• Negative Effect Questionnaire (NEQ)

  Immediately after the intervention

Study Arms (2)

Online psychological intervention

EXPERIMENTAL

Online psychological intervention with written support from a psychologist

Behavioral: Online psychological intervention

Individual psychological intervention

ACTIVE COMPARATOR

Individual therapy sessions with a psychologist

Behavioral: Individual psychological intervention

Interventions

Online psychological intervention BEHAVIORAL

The online intervention constitutes a psychological intervention rooted in therapeutic principals of Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT). Comprising 7 obligatory modules and 4 optional modules, the intervention is facilitated through an online platform, offering a text-based self-help program. Patients receive written guidance from a psychologist at Steno Diabetes Center Odense (SDCO). While undergoing intervention, patients have the option to seek clarification or assistance from the psychologist if encountered with queries or difficulties. It is anticipated that patients will progress through approximately one module per week. Following completion of the intervention, patients retain access to the online intervention for a duration of 3 months.

Online psychological intervention

Individual psychological intervention BEHAVIORAL

In the individual intervention, patients undergo personalized therapy administered by the assigned psychologist from SDCO. This treatment approach is grounded in the principles of Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT). Delivery of treatment can occur through various modalities, including telephone, video conferencing, or in-person sessions, tailored to accommodate the preferences and requirements of the patient. A maximum of 10 treatment sessions are available for each patient.

Individual psychological intervention

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A total score or a score on one of the subscales of the Diabetes Distress Scale for type 1 diabetes which is 2 or above.
• Diagnosed with type 1-diabetes ≥ 12 months ago.
• Age ≥ 30 years.
• Receiving treatment at SDCO.
• Proficiency in Danish and basic IT skills.

You may not qualify if:

• Psychiatric diagnosis that may compromise participation in the intervention e.g. psychosis, schizophrenia, substance or alcohol abuse.
• Cognitive impairments that may compromise participation in the intervention e.g. dementia, Alzheimer's, brain injury.
• Complex issues best suited for individual treatment as assessed by the clinical psychologist.

Sponsors & Collaborators

• Odense University Hospital: lead
• Center for Digital Psykiatri: collaborator

Study Sites (1)

Steno Diabetes Center Odense

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Christina M andersen, PhD

CONTACT

0045 27591761; christina.maar.andersen@rsyd.dk

Mette J Rothmann, PhD

CONTACT

0045 24257094; mette.rothmann@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Online psychological intervention 2. Individual psychological intervention

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 31, 2024
• Study Start: June 20, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)