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UK MyREMEDY Clinical Trial

ConditionsType 1 DiabetesDiabetes Distress
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing's College London

About this trial

The UK MyREMEDY study investigates whether MyDiaMate, an online self-help program, can effectively improve the mental health of adults with type 1 diabetes compared to those receiving care as usual.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years old at signing the informed consent form

Type 1 diabetes diagnosis at least 6 months ago

Having access to the internet and a smartphone/tablet/laptop/computer for the entirety of study participation

Experiencing diabetes distress (checked during a phone call between research assistant and participant. The condition is met if the participant has an average score of ≥2 on the 2-item Diabetes Distress Scale [DDS-2], representing clinically meaningful diabetes distress)

Disqualifiers

Having been diagnosed with a psychiatric disorder in the past 6 months for which the person is under psychological/psychiatric treatment

Suicidality

Having started a treatment with psychotropic medication in the past 3 months

Cannot read and speak English

Trial design

Design model

Parallel

Treatments tested in this trial

  • MyDiaMate

    Behavioral

    MyDiaMate program

Treatment groups

165 Participants
are divided into 2 treatment groups
Group A: MyDiaMateExperimental treatment 1 intervention
Group B: Care as UsualNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Diabetes Distress

Diabetes Distress will be assessed through the 20-item Problem Areas In Diabetes questionnaire (PAID-20). The PAID questionnaire measures diabetes distress on a 5-point Likert scale ranging from 1 (not a problem) to 5 (serious problem). A higher score represents higher diabetes distress.

Time frame
Diabetes Distress will be assessed at 0 months (baseline), 3 months (intervention effects), and after 6 months (follow-up).

Secondary outcomes

1

Emotional well-being

Emotional well-being will be operationalised as the score on the 5-item World Health Organization Well-Being Index (WHO-5). The score on the WHO-5 is measured on a 6-point scale ranging from 0 (at no time) to 5 (all of the time), with a lower score representing less emotional well-being.

Time frame
Emotional well-being will be assessed at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).
2

Psychological self-efficacy in relation to diabetes

Operationalised through the short form of the Diabetes Empowerment Scale (DES-SF). Psychological self-efficacy in relation to diabetes is assessed on a 5-point scale ranging from 0 (strongly disagree) to 4 (strongly agree), with higher scores representing higher psychological self-efficacy in relation to diabetes.

Time frame
Psychological self-efficacy in relation to diabetes will be assessed at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).
3

Social engagement

Social engagement will be assessed through the 6-item Lubben Social Network Scale (LSNS-6). The LSNS measures social engagement on a 6-point scale ranging from 0 (none) to 5 (nine or more). A higher score represents higher social engagement.

Time frame
Social engagement will be measured at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).
4

Fatigue

Fatigue will be assessed through the 8-item Fatigue subscale of the Checklist Individual Strength (CIS-F). The CIS-F consists of both positively and negatively framed items that are measured on a 7-point scale ranging from 1 (no, that is not true) to 7 (yes, that is true). The positively framed items (e.g., I feel fit) will be reverse coded. A higher score will therefore represent stronger fatigue.

Time frame
Fatigue will be measured at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King's College London

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborator

Forschungsinstitut der Diabetes Akademie Mergentheim

Collaborator

University of Malaga

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: