Community-based Cognitive Behavioral Therapy for Type 2 Diabetes
Condition: Type 2 Diabetes; Depression
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Intervention name(s): CBCBT intervention; Adherence counseling; Psycho-education package
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 8 group CBT sessions and 4 weekly follow-up calls; 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.
Other intervention name(s): CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: telephone follow-up; sustainability; cognitive behavioural therapy