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NCT02914496Active, not recruiting

ACT Stress Management in Type 1 Diabetes

"Diabetes in Balance" - a Randomized Controlled Trial to Evaluate the Effects on Glucose Control, Self-care and Psychosocial Factors?

Source: ClinicalTrials.gov · Last updated 25 Jul 2025

Brief summary (registry, in English)

For many people living with type 1 diabetes it is a challenge to achieve good glucose control. Barely 20% reaches the goal level and many people experience self-care as complex, demanding and stressful. The purpose of this study is to evaluate the effect of a stress-management program on glucose control, self-care and psychosocial factors. The program is based on Acceptance and Commitment Therapy (ACT), a specific form of Cognitive behavior therapy (CBT). A total of 70 adult patients with type 1 diabetes from Ersta hospital will be recruited. Half of them will receive the intervention and the other half will continue with their regular diabetes care. A licensed psychologist specialised in CBT and a diabetes specialist nurse will be leading the intervention that is given in a group format. The program consists of seven 2-hour sessions given over 14 weeks. Glucose control, self care and stress will be measured at inclusion, after session four and seven, at six , 12 and 24 months and finally after 5 years

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
81 (actual)
First submitted
15 Sept 2016
Start date
15 Oct 2016
Primary completion date
30 Jun 2020
Lead sponsor
Karolinska Institutet
NCT number
NCT02914496

What you commit to

  • Study type: Interventional
  • Participants enrolled: 81
  • From 15 Oct 2016 to the primary completion date, 30 Jun 2020
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Insulin pump therapy started since \<3 months

Other illness

  • Untreated or severe ongoing psychiatric disease
  • Untreated thyroid disease

Other

  • Insufficient knowledge to understand and express themselves in Swedish
  • Cortisone treatment

Who the study is looking for

  • Type 1 diabetes
  • Duration of disease \>2 years -
  • Hb1c\>60 mmol/mol

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ersta sjukhus
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.