Use of an Online Intervention for the Treatment of Diabetes Distress in Patients With Type 1-Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorOdense University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Online psychological intervention
BehavioralThe 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.
Individual psychological intervention
BehavioralIn 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Online psychological interventionExperimental treatment 1 intervention
Group B: Individual psychological interventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Throughout the duration of the study approx. 12 months2
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
Time frame
Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention3
Characteristics of patients receiving the interventions and those who drop out assessed through survey data.
Patient characteristics assessed through survey data
Time frame
Throughout study participation, an average of 6 months4
Acceptability of the online intervention expressed by patients
Will be assess by expressions of patients through qualitative semi structured interviews
Time frame
After completion of the intervention, an average of 3-12 monthsSecondary outcomes
1
Diabetes Distress Scale for type 1 diabetes (T1 DDS)
The T1 DDS measures diabetes distress. The scale consists of 28 items with each item with 6 answer categories ranging from 1 'Not a problem' to 6 'A serious problem'. A total score is calculated by adding all the items together and diving the number by 28. A score between 2,0 and 2,99 indicated moderate diabetes distress and a score of ≥ 3 indicate high levels of diabetes distress
Time frame
Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention2
Acceptance & Action Diabetes Questionnaire (AADQ-6)
The AADQ-6 measures diabetes acceptance through 6 items with scores ranging from 1 'Never' to 5 'Almost always'.The scores range from 6-30 with higher values indicate greater non-acceptance
Time frame
Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention3
The Patient Activation Measure (PAM)
The PAM assesses patient engagement in healthcare. Three key domains are assessed to understand a person's self-management ability: Knowledge, Skills, Confidence. The scale has 13 items with four answer categories from 'Highly agree' to 'Highly disagree' and a 'Do not know' category. The scores are calculated through an excel spreadsheet created by InsigniaHealth and range from 0-100 with higher scores indicating higher patient activation.
Time frame
Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention4
The DAWN (Diabetes Attitudes, Wishes and Needs study) Impact of Diabetes Profile (DIDP)
The DIPD measures diabetes-related quality of life. There scale has 6 items assessing how diabetes affect the following areas (physical health, mental health, relationships, leisure activities, work or studies, financial situation), and two optional items (ability to eat what one wants and overall happiness). Each item can be evaluated using a 7-point scale, where 1 indicates 'A very positive impact', 4 indicates 'No impact', and 7 indicates 'A very negative impact'. Additionally, there is a "not applicable" (N/A) response option available for each item. A higher score indicates lower diabetes-related quality of life.
Time frame
Immediately before enrollment in the intervention, immediately after the intervention and three months after the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Odense University Hospital
Lead sponsor
Center for Digital Psykiatri
Collaborator
Source ClinicalTrials.gov