Community-based Cognitive Behavioral Therapy for Type 2 Diabetes

June 5, 2023 updated by: Dr. Au May-lan Alma, The Hong Kong Polytechnic University

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Hong Kong, Hong Kong
        • Applied Social Sciences, Hong Kong Polytechnic University
      • Kowloon, Hong Kong
        • Institute of Active Ageing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBCBT intervention
  1. Adherence counseling
  2. Psycho-education package
  3. 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.
8 group CBT sessions and 4 weekly follow-up calls
Other Names:
  • CBT
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.
Active Comparator: enhanced treatment as usual (ETAU)
  1. Adherence counseling;
  2. Psycho-education package;
  3. 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline through study completion, an average of 24 weeks
Glycemic control
Time Frame: Change from baseline through study completion, an average of 24 weeks
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)
Time Frame: Change from baseline through study completion, an average of 24 weeks
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
Time Frame: Change from baseline through study completion, an average of 24 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alma Au, PhD, Applied Social Sciences, Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2018

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

May 22, 2017

First Submitted That Met QC Criteria

February 6, 2020

First Posted (Actual)

February 7, 2020

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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