ACT Stress Management in Type 1 Diabetes

NCT02914496 | Active Not Recruiting

• 1 other identifier: EPN Stockhom 2016/14-31/1
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Measure of long term glucose control

  12 months post inclusion

Secondary Outcomes (6)

• Manchester Short Assessment of Quality of life

  1-5 years post inclusion

• Depression Anxiety stress scales

  1-5 years post inclusion

• The Hypoglycemia Fear Survey emotions, depression, anxiety, fear of hypoglycemia, general and diabetes related distress.

  1-5 years post inclusion

• The Problem Areas in Diabetes (Swe-PAID-20) Scale

  1-5 years post inclusion

• Acceptance and action diabetes questionnaire

  1-5 years post inclusion

Study Arms (2)

Diabetes in Balance

EXPERIMENTAL

The intervention consists of the manual-based CBT-group intervention "Diabetes in Balance". It is given in a group format with six to ten participants and consists of 7 sessions. The sessions are given bi-weekly for two hours. Each session has a specific theme such as "Stress and acceptance" "The life-compass; what is important in my life". The participants also conduct assignments related to the themes between the sessions. A licensed psychologist specialised in CBT and a diabetes specialist nurse, both trained in "ACT-stress management" will be leading the intervention group.

Behavioral: Acceptance and Commitment Therapy (ACT)

Control

NO INTERVENTION

The control group receives regular care including regular visits at the out-patient clinic, 3-4 times per year.

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

ACT is a specific form of Cognitive behavior therapy (CBT) which will be given as a course consisting of seven sessions where each session is two hours long.

Also known as: Diabetes in Balance

Diabetes in Balance

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Insufficient knowledge to understand and express themselves in Swedish
• Untreated or severe ongoing psychiatric disease
• Cortisone treatment
• Untreated thyroid disease
• Insulin pump therapy started since \<3 months

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Ersta sjukhus

Stockholm, Stockholm County, 11691, Sweden

Location

Related Publications (2)

• Wijk I, Amsberg S, Johansson UB, Livheim F, Toft E, Anderbro T. Impact of an Acceptance and Commitment Therapy programme on HbA1c, self-management and psychosocial factors in adults with type 1 diabetes and elevated HbA1c levels: a randomised controlled trial. BMJ Open. 2023 Dec 14;13(12):e072061. doi: 10.1136/bmjopen-2023-072061.

  PMID: 38101850 DERIVED

• Amsberg S, Wijk I, Livheim F, Toft E, Johansson UB, Anderbro T. Acceptance and commitment therapy (ACT) for adult type 1 diabetes management: study protocol for a randomised controlled trial. BMJ Open. 2018 Nov 28;8(11):e022234. doi: 10.1136/bmjopen-2018-022234.

  PMID: 30498037 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Therese Anderbro, AssProf

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 15, 2016
• First Posted: September 26, 2016
• Study Start: October 15, 2016
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)