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
1 other identifier
interventional
182
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Oct 2012
Shorter than P25 for not_applicable diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 9, 2015
CompletedFirst Posted
Study publicly available on registry
June 16, 2015
CompletedJune 16, 2015
June 1, 2015
9 months
June 9, 2015
June 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Study Arms (2)
Minimal Psychological Intervention
EXPERIMENTALParticipants 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
OTHERParticipants in this group received usual care only.
Interventions
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 was given by their family physicians.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Diabetes disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 9, 2015
First Posted
June 16, 2015
Study Start
October 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
June 16, 2015
Record last verified: 2015-06