Clinical trial NCT04261361: Community-based Cognitive Behavioral Therapy for Type 2 Diabetes
Official title: A Randomized Controlled Trial of Community-based Cognitive Behavioral Therapy for Type 2 Diabetes in Hong Kong
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Depression
Keywords: telephone follow-up
sustainability
cognitive behavioural therapy
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 168
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Depressive symptoms
timeFrame: Change from baseline through study completion, an average of 24 weeks
measure: Glycemic control
timeFrame: Change from baseline through study completion, an average of 24 weeks
Secondary outcomes:
measure: The Summary of DM Self-care Activities Questionnaire (SDSCA)
timeFrame: Change from baseline through study completion, an average of 24 weeks
measure: DM-specific distress
timeFrame: Change from baseline through study completion, an average of 24 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Applied Social Sciences, Hong Kong Polytechnic University
city: Kowloon
country: Hong Kong
facility: Institute of Active Ageing
Study officials:
affiliation: Applied Social Sciences, Hong Kong Polytechnic University
name: Alma Au, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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