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ID
Source
Brief title
Health condition
Diabetes Mellitus, depression, diabetes self-care behaviour, Acceptance and Commitment Therapy
Sponsors and support
Intervention
Outcome measures
Primary outcome
Depression: VAS by PsyMate (App for smartphone)
Diabetes self-care behaviour: Self-Care Inventory-revised (SCI-R) (blood glucose regulation)
Secondary outcome
Acceptance: Acceptance and Action Questionnaire- II (AAQ-II)
Cognitive fusion: Cognitive Fusion Questionnaire (CFQ13)
Background summary
Diabetes Mellitus (DM) is associated with a doubled risk of depressive symptoms compared to the general population. Concurrent diabetes and depressive symptoms are related to poorer emotional functioning, quality of life, self-care behaviours and health outcomes. Acceptance and Commitment Therapy (ACT) is a psychological intervention that mixes acceptance and mindfulness strategies with commitment and behaviour-change strategies in order to increase psychological flexibility, including acceptance and cognitive defusion (disentanglement from our thoughts). Several meta-analyses have shown the effectiveness of ACT. In diabetes, ACT has been proven effective on diabetes self-care, acceptance coping strategies and glycaemic control. ACT for patients with diabetes and depressive symptoms has not yet been studied. The aim of the present study is to examine the effectiveness of an ACT intervention on depressive symptoms and diabetes self-care behaviour in insulin-treated DM patients. In addition, we explore the underlying operating mechanisms of ACT.
Study objective
Firstly, we hypothesise that Acceptance and Commitment Therapy (ACT) for diabetes patients will reduce depressive symptoms and will increase diabetes self-care behaviour. Furthermore, we explore the underlying operating mechanisms of ACT. We hypothesise that ACT for diabetes patients will increase psychological flexibility, including acceptance and cognitive defusion.
Study design
This is a replicated randomised single-case experimental study. This means a low number of participants with highly frequent measurements.
Depression is measured daily during the base-line and the intervention period. Diabetes self-care behaviour, acceptance and cognitive fusion are measured weekly, during the baseline period and the intervention period. Total study period for each participant is 25 weeks. Moment of phase change from base-line to intervention phase is randomised.
Intervention
Acceptance and Commitment Therapy (ACT) consisting of eight one-and-a-half hour individual sessions across ten weeks
Linda Vondenhoff
Dr. H. van der Hoffplein1
Sittard 6162 BG
The Netherlands
088-4597837
l.vondenhoff@orbisconcern.nl
Linda Vondenhoff
Dr. H. van der Hoffplein1
Sittard 6162 BG
The Netherlands
088-4597837
l.vondenhoff@orbisconcern.nl
Inclusion criteria
1. age 18 to 65 years;
2. a diagnosis type 1 or type 2 diabetes mellitus > 6 months ago;
3. suboptimal glycaemic control (HbA1c ≥7.5%/58mmol/mol)
4. intensive insulin treatment (at least 4 dialy administrations regimen; or insulin pump therapy)
5. elevated depressive symptoms (CES-D ≥ 16);
6. motivation for an 8-session psychological intervention focusing on acceptance in chronic illness (based on clinical judgement).
Exclusion criteria
1. severe psychiatric or somatic comorbidity that hampers participation (e.g. depression with strong suicidal ideation, psychosis, severe cognitive impairment, severe cardiac disease, end-stage cancer);
2. non-fluent in Dutch language, an intellectual disability or lack of verbal abstraction (based on educational level and clinical judgement);
3. earlier treatment based on ACT and/or MBCT;
4. ongoing other psychological treatment;
5. changes in antidepressive medication during the study period;
6. pregnancy.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL5562 |
| NTR-old | NTR5683 |
| Other | : 15-N-172 METC Zuyd |