Objectives: The aim of the study is evaluate the efficacy of a telephone assisted cognitive behavioral therapy for adherence (CBCBT) in type 2 diabetes. Hypothesis: CBCBT will primarily reduce depressive symptoms and improve glycemic control and secondarily, improve adherence and self-care and reduce diabetes-specific distress. Design and subjects: This is a prospective randomized two-armed intervention study. One hundred sixty eight participants will be recruited from five sites covering the following clusters: New Territories East, Kowloon East and Hong Kong West. Intervention: The CBT protocol (Safren et al., 2013) will be used in the intervention. Specific components include: 1) introducing CBT for behavior change, 2) increasing pleasurable activities and mood monitoring, 3) cognitive restructuring, 4) problem-solving in self-care and 5) relaxation training. To maximize accessibility, eight sessions will be delivered face-to-face in group setting and the other four sessions will be delivered by telephone. Three monthly follow-up telephone calls will be made to consolidate treatment gains. Main outcome measures: Primary outcomes include the Beck Depression Inventory and glycemic control. Secondary outcomes include self-care and diabetes-specific distress. Data analysis: Treatment outcomes will be assessed by Repeated Measures ANOVA and also Intention to Treat Analysis. Regression models will be used to estimate effect sizes and associations among variables. Expected results: CBCBT would significantly reduce depressive symptoms and improve glycemic control. With secondary outcomes, CBCBT will improve self-care and reduce diabetes-specific distress.
A community-based CBCBT is tested for patients living with diabetes(DM) and subclinical depression. The program includes both face-to-face group sessions and individual telephone sessions. The aim of the current study is to evaluate the efficacy of a mixed mode CBCBT in reducing depressive symptoms and enhancing adherence among adults with DM and subclinical depression. The intervention program consists of three components: 1) eight weekly sessions of face-to-face interventions, 2) four weekly consolidation individual telephone calls and 3) three monthly individual follow-up phone calls. This is a prospective randomized two-armed intervention study. The CBCBT intervention will be compared with enhanced treatments usual (ETAU) using a single blinded randomized design. The intervention will be delivered by qualified health care professional (e.g. clinical psychology/ social worker/ nurse counsellor) who have had some training in CBCBT in the initial training.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
168
8 group CBT sessions and 4 weekly follow-up calls
All participants in both CBCBT and ETAU groups will have one session of Life-Steps, a stand-alone CBCBT intervention designed to improve adherence to medical recommendations and individualized DM self-management goals.
Printed materials of a DM self-management education program will be delivered to both the CBCBT and ETAU groups.
Applied Social Sciences, Hong Kong Polytechnic University
Hong Kong, Hong Kong
Institute of Active Ageing
Kowloon, Hong Kong
Depressive symptoms
The Beck Depression Inventory (BDI-I) assesses cognitive, behavioral and somatic symptoms of depression.
Time frame: Change from baseline through study completion, an average of 24 weeks
Glycemic control
Glycated haemoglobin (HbA1c) is used to measure glycemic control
Time frame: Change from baseline through study completion, an average of 24 weeks
The Summary of DM Self-care Activities Questionnaire (SDSCA)
The revised 11-item SDSCA assess aspects of diabetes self-management that includes diet, exercise, self-monitoring of blood-glucose, foot care, and smoking in the past 7 days (0-7 points) by self-reported frequency.
Time frame: Change from baseline through study completion, an average of 24 weeks
DM-specific distress
The DM Distress Scale (DDS) is a 17-item self-administered questionnaire identifying four domains of DM-related distress: emotional burden, physician-related distress, regimen related distress, and interpersonal distress
Time frame: Change from baseline through study completion, an average of 24 weeks
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