Last updated on February 2020

Cognitive Behavioural Therapy for Adherence and Sub-clinical Depression for Type 2 Diabetes

Brief description of study

Objectives: The aim of the study is evaluate the efficacy of a telephone assisted cognitive behavioral therapy for adherence (CBT-AD) in type 2 diabetes.

Hypothesis: CBT-AD 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-AC protocol (Safren et al., 2013) will be used in the intervention. Specific components include: 1) introducing CBT-AD 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-II (BDI-II) and glycemic control. Secondary outcomes include adherence by the Morisky Medication Adherence Scale, 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: CBT-AD would significantly reduce depressive symptoms and improve glycemic control. With secondary outcomes, CBT-AD will improve adherence and self-care and reduce diabetes-specific distress.

Detailed Study Description

A program based on CBT-AD 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 CBT-AD 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 CBT-AD 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 CBT in the initial training.

Clinical Study Identifier: NCT04261361

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