Minimal Psychological Intervention in Diabetes Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the telephone-delivered Minimal Psychological Intervention (MPI) could improve diabetes' depressive symptom and diabetes-related immediately , as well as HbA1c level in the long-term.

Official Title
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The Long-term Effect of a Minimal Psychological Intervention on Type 2 Diabetes Patients' Depressive Symptom, Diabetes-related Distress and Glycemic Control

Conditions
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Diabetes Mellitus, Type 2, Depression

Intervention / Treatment
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* Behavioral: Minimal psychological intervention
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Diabetes disease Exclusion Criteria: Were using anti-depression medication With ongoing psychological/psychiatric treatment Had been diagnosed with psychosis (ex. schizophrenia or bipolar disorder) Had severe cognitive problem or hearing impairment Lost their partner within three months

Ages Eligible for Study
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Minimum Age: 50 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimal Psychological Intervention<br>Participants allocated to this group not only received the usual care as given by their family physicians, but also accepted biweekly minimal psychological intervention via telephone during six weeks. | Behavioral: Minimal psychological intervention<br>* Minimal psychological intervention (MPI) was used to help adults with chronic illness to manage their psychological burden by breaking through a negative spiral between thoughts and behaviors.<br>Other: Usual care<br>* Usual care was given by their family physicians.<br>|
| Other: Usual care<br>Participants in this group received usual care only. | Other: Usual care<br>* Usual care was given by their family physicians.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptom assessed by CES-D 10 | Depressive symptom score was assessed with the 10-item Center for Epidemiologic Studies Depression Scale (CES-D 10). | At three points in time: at baseline (wave 1), post-intervention or 6 weeks after randomization (wave 2), and 1 month after the intervention period or 10 weeks after randomization (wave 3) | 
| Diabetes-related distress assessed by PAID scale | Diabetes-specific emotional distress was assessed with the Problem Areas in Diabetes (PAID) scale. | At three points in time: at baseline (wave 1), post-intervention or 6 weeks after randomization (wave 2), and 1 month after the intervention period or 10 weeks after randomization (wave 3) | 
| Hemoglobin A1c |  | Participants were measured during entire follow-up period, an average period of 3 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Minimal psychological intervention, Glycemic control, Depressive symptoms, Problem Area in Diabetes, Middle-aged and older adults, HbA1c protein, human