Community-based Cognitive Behavioral Therapy for Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial of Community-based Cognitive Behavioral Therapy for Type 2 Diabetes in Hong Kong

Conditions
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Type 2 Diabetes, Depression

Intervention / Treatment
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* Behavioral: CBCBT intervention
* Behavioral: Adherence counseling
* Behavioral: Psycho-education package


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBCBT intervention<br>Adherence counseling Psycho-education package 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. | Behavioral: CBCBT intervention<br>* 8 group CBT sessions and 4 weekly follow-up calls<br>* Other names: CBT;Behavioral: Adherence counseling<br>* 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.<br>Behavioral: Psycho-education package<br>* Printed materials of a DM self-management education program will be delivered to both the CBCBT and ETAU groups.<br>|
| Active Comparator: enhanced treatment as usual (ETAU)<br>Adherence counseling; Psycho-education package; To maintain some control over the contact time, we will give them 4 bi-weekly individual phone calls of about 10 minutes each while the CBCBT intervention group is having their 8 weeks of face-to-face group sessions. | Behavioral: Adherence counseling<br>* 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.<br>Behavioral: Psycho-education package<br>* Printed materials of a DM self-management education program will be delivered to both the CBCBT and ETAU groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms | The Beck Depression Inventory (BDI-I) assesses cognitive, behavioral and somatic symptoms of depression. | Change from baseline through study completion, an average of 24 weeks | 
| Glycemic control | Glycated haemoglobin (HbA1c) is used to measure glycemic control | Change from baseline through study completion, an average of 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Change from baseline through study completion, an average of 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telephone follow-up, sustainability, cognitive behavioural therapy