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Completed

NCT Number: NCT02473081

Minimal Psychological Intervention in Diabetes Patients

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Behavioral Symptoms Depression Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimal psychological intervention

Behavioral

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.

Usual Care

Other

Usual care was given by their family physicians.

Primary outcomes

  1. Depressive symptom assessed by CES-D 10

    Time frame: 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).

  2. Diabetes-related distress assessed by PAID scale

    Time frame: 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.

  3. Hemoglobin A1c

    Time frame: Participants were measured during entire follow-up period, an average period of 3 months.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 16, 2015
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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