Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02914496 |
| Other study ID # |
EPN Stockhom 2016/14-31/1 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 15, 2016 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
April 2023 |
| Source |
Karolinska Institutet |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
Description:
ACT-stress management in type 1 diabetes - a randomized controlled trial to evaluate the
effect on glucose control, self-control and psychosocial factors.
Purpose of proposed investigation:
The project hypothesis are that the CBT-intervention will a) improve glucose control,
self-care, quality of life and acceptance of diabetes related thoughts and emotions and b)
decrease depression, anxiety, general and diabetes related distress and fear of hypoglycemia.
Background information for the project:
The overall goal of diabetes management is to achieve good glycemic control while still
maintaining good quality of life and experiencing as few hypoglycemic episodes as possible
(the Swedish Social Board of Welfare, 2010). Currently only 19% of people with diabetes reach
the goal of 52 mmol/mol for glycemic control (National Diabetes Registry, 2014). Research has
proposed difficulties with behavior change (Knight et al., 2006), diabetes related distress
(van Bastelar et al., 2010, Fisher et al., 2010) and fear of hypoglycemia (Wild et al., 2007)
as important obstacles in achieving the goal. Patient education plays an important role in
diabetes care but may not be sufficient in order to reach the recommended treatment goals.
The association between knowledge and behavior change is weak and research has suggested that
interventions should be more behavior oriented (Knight et al., 2006, Funnell et al., 2008).
It is well known that people with chronic disease have an increased risk of developing
psychological problems, for instance there are studies showing up to four times higher
prevalence of depression in people with type 1 diabetes (Roy & Lloyd, 2012). It is also known
that psychological problems are associated with poorer glycemic control, health and quality
of life in this group (Chiechanowski et al., 2000; Jacobson, 2004).
Therefore, it is urgent to quickly discover and treat psychological problems. There is
scientific support for Cognitive Behavior Therapy (CBT) to be effective in treating different
types of anxiety (Stewart & Chambless, 2009) and depression (Cuijpers et al., 2011).
In light of this, different CBT-based interventions have been suggested as promising
alternatives in treating diabetes. Several programs based on CBT have also been scientificly
evaluated. Some of these studies have focused on changing concrete every day behaviors in
order to promote self-care, glycemic control and quality of life (Snoek et al., 2008, Amsberg
et al., 2009a,b) and some to treat co-morbid depression (Lustman et al., 1998). Our previous
intervention study in this field (Amsberg et al., 2009 a, b) was the first one to show
significant positive effects on glycemic control. In recent years a new form of CBT,
Acceptance and Commitment Thearpy, (ACT), (Hayes, Strosahl, & Wilson, 1999) has received
scientific attention. Of particular interest is that relatively short ACT-interventions in
several studies have shown good results in a wide variety of psychosocial problems, smoking
cessation, work related stress, anxiety, depression, chronic pain, epilepsi (Hayes et al.,
2006).
" ACT-stressmanagement" is an intervention originally developed for preventing work-related
stress and illness (Bond & Bunce, 2003) that later has been modified for different groups of
peopel such as high-school students (Livheim, 2004), social workers (Brinkborg et al., 2011),
medical students (Andersson & Waller, 2011). The intervention is designed so that different
types of professionals, not only psychologists, can serve as group-leaders after a short
period of training.
Plan of investigation:
The intervention "ACT-stress-management" will in this study be given as a course consisting
of seven sessions where each session is two hours long. The course has been modified for
people with diabetes so that the excercises and information will be related to diabetes and
diabetes related problems. The sessions will be held every other week. The groups will
consist of between six to a maximum of ten participants.
Subjects Inclusion criteria will be all adult (18-70 years) type 1 diabetes patients with
HbA1c > 60 mmol/mol registered at Ersta hospital, diabetes- and endochrinology
department/unit. The patient must be able to read, write and speak Swedish. Those with severe
psychiatric conditions such as psychosis, recurrent severe depression or post-traumatic
stress disorder, those with an ongoing cortison treatment, with co-morbid severe illness that
affects glycemic control or are pregnant will be excluded.
Power-calculation:
A total of 56 patients (28 in the intervention group and 28 in the control group) are needed
to achieve 80% power to detect the clinically relevant decrease of 6 mmol (The Association of
Physical Activity, 2015) in HbA1c with 5% significance level and an SD of 9 mmol. In order to
take in account of a drop-out rate of 24 % (Amsberg et al., 2008) during the study a total of
70 patients are needed to be included. The power-calculation was done with a web-based
power-caculator.
Procedure:
The study consists of five main steps: 1. Recruitment of participants 2. The intervention 3.
Psychometric evaluation of the Swedish version of AADQ 4. Data-processing 5. Presentation of
the results
1. Recruitment of participants We will recruit a total of 70 patients during 2-3 years, of
which half will receive the "ACT-stress-management" program and half will continue with
treatment as usual. Patients fulfilling the inclusion criteria will meet the person
collecting the data at the diabetes-center in order to receive information of the study
and will at the same time be asked to participate in the study. At this time the
participants will be informed orally and in writing about the study, recieve information
about their possibility to leave the study at any time without any consequences, how
data will be handled and finally about receiving a compensation in the form of a gift
voucher of 100 SEK after each time they complete a set of questionnaires.
2. The intervention The intervention consists of: "The ACT-stressmanagement" intervention
and administrating pre-intervention measurements, processmeasurments, post-intervention
measurements and follow-up measurements. The control-group will only consist of the
pre-, process-, post and follow-up measurements.
The intervention-group:
1. Informed consent for the study
2. After agreeing to being included, participants complete the set of questionnaires for
base-line measures
3. "the ACT-stressmanagement" is given, including two process-measurements of AADQ
4. Post-intervention measurments
5. 1-year post inclusion follow-up measurements
6. 2-year post inclusion follow-up measurements
7. 5- year post inclusion follow-up measurements
The control-group:
1. Informed consent for the study
2. After agreeing to being included, participants complete the set of questionnaires for
base-line measures
3. Treatment as usual, including two process-measurements of AADQ
4. Post-intervention measurments
5. 1-year post inclusion follow-up measurements
