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Minimal Psychological Intervention in Diabetes Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02473081
Enrollment
182
Registered
2015-06-16
Start date
2012-10-31
Completion date
2013-07-31
Last updated
2015-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes, Minimal psychological intervention, Glycemic control, Depressive symptoms, Problem Area in Diabetes, Middle-aged and older adults, HbA1c protein, human

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.

Interventions

BEHAVIORALMinimal 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.

OTHERUsual care

Usual care was given by their family physicians.

Sponsors

National Science and Technology Council, Taiwan
CollaboratorOTHER_GOV
National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Depressive symptom assessed by CES-D 10At 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 scaleAt 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.
Hemoglobin A1cParticipants were measured during entire follow-up period, an average period of 3 months.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026