A Randomized Controlled Trial of Community-based Cognitive Behavioral Therapy for Type 2 Diabetes in Hong Kong
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 168
- Locations
- 2
- Primary Endpoint
- Glycemic control
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients have to meet the following criteria: 1) aged between 25 to 60 years; 2) living with Type 2 DM, 3) community dwelling, 4) independent in their activities of daily living as indicated on the Barthel Index and 5) obtained on screening a score of 5 to 9 on the Patient Health Questionnaire Depression Scale (PHQ-9).
Exclusion Criteria
- •Patients will be excluded by a clinician/ investigator for major depression within the past 6 months, lifetime history of other psychiatric disorder including psychosis, schizophrenia ad bipolar affective disorder, serious suicidal risk, alcohol or substance abuse and medical illnesses with prognosis of less than 12 months to live (as identified by reviewing their medical history), already taking medication or receiving psychological intervention for depressive disorders or related symptom, bedridden, having memory loss, not being able to understand or communicate in Chinese language, or refusing to give consent.
Outcomes
Primary Outcomes
Glycemic control
Time Frame: Change from baseline through study completion, an average of 24 weeks
Glycated haemoglobin (HbA1c) is used to measure glycemic control
Depressive symptoms
Time Frame: Change from baseline through study completion, an average of 24 weeks
The Beck Depression Inventory (BDI-I) assesses cognitive, behavioral and somatic symptoms of depression.
Secondary Outcomes
- The Summary of DM Self-care Activities Questionnaire (SDSCA)(Change from baseline through study completion, an average of 24 weeks)
- DM-specific distress(Change from baseline through study completion, an average of 24 weeks)
Investigators
Dr. Au May-lan Alma
Associate Professor
The Hong Kong Polytechnic University