Minimal Psychological Intervention in Diabetes Patients

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Depression
• Interventions: Behavioral: Minimal psychological intervention; Other: Usual care

• Registration Number: NCT02473081
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2015-06
• Study First Submitted: 2015-06-09
• Study First Submitted QC: 2015-06-11
• Last Update Submitted: 2015-06-11
• Study First Posted: 2015-06-16
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minimal Psychological Intervention	Usual care	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.
Minimal Psychological Intervention	Minimal psychological intervention	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.
Usual care	Usual care	Participants in this group received usual care only.

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	Participants were measured during entire follow-up period, an average period of 3 months.
Depressive symptom assessed by 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)	Depressive symptom score was assessed with the 10-item Center for Epidemiologic Studies Depression Scale (CES-D 10).
Diabetes-related distress assessed by 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)	Diabetes-specific emotional distress was assessed with the Problem Areas in Diabetes (PAID) scale.