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Effectiveness of Acceptance and Commitment Therapy for patients with insulin-treated diabetes and depressive symptoms: ACT in Diabetes


- candidate number23654
- NTR NumberNTR5683
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-jan-2016
- Secondary IDs15-N-172 METC Zuyd 
- Public TitleEffectiveness of Acceptance and Commitment Therapy for patients with insulin-treated diabetes and depressive symptoms: ACT in Diabetes
- Scientific TitleEffectiveness of Acceptance and Commitment Therapy for patients with insulin-treated diabetes and depressive symptoms: ACT in Diabetes. A replicated randomised single case experimental study.
- ACRONYMACT in Diabetes
- hypothesisFirstly, 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.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus, Depression, Therapy
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- control[default]
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-mrt-2016
- planned closingdate31-okt-2017
- Target number of participants3
- InterventionsAcceptance and Commitment Therapy (ACT) consisting of eight one-and-a-half hour individual sessions across ten weeks
- Primary outcomeDepression: VAS by PsyMate (App for smartphone)
Diabetes self-care behaviour: Self-Care Inventory-revised (SCI-R) (blood glucose regulation)
- Secondary outcomeAcceptance: Acceptance and Action Questionnaire- II (AAQ-II)
Cognitive fusion: Cognitive Fusion Questionnaire (CFQ13)
- TimepointsThis 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.  
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIESDrs. Linda Vondenhoff
- CONTACT for SCIENTIFIC QUERIESDrs. Linda Vondenhoff
- Sponsor/Initiator Zuyderland Medical Center, Heerlen
- Funding
(Source(s) of Monetary or Material Support)
Zuyderland Medical Center, Heerlen
- Publications
- Brief summaryDiabetes 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.
- Main changes (audit trail)
- RECORD26-jan-2016 - 4-apr-2016


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