Minimal Psychological Intervention in Diabetes Patients

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473081
• Other study ID #: NSC 101-2314-B-006-001-
• Status: Completed
• Phase: N/A
• First received: June 9, 2015
• Last updated: June 11, 2015
• Start date: October 2012
• Est. completion date: July 2013

Study information

• Verified date: June 2015
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Minimal psychological intervention
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.

Other:
• Usual care
Usual care was given by their family physicians.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital	National Science Council, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	Hemoglobin A1c		Participants were measured during entire follow-up period, an average period of 3 months.	No