Diabetes Mellitus, Type 2NCT02473081
Minimal Psychological Intervention in Diabetes Patients
A study testing Minimal psychological intervention in people with Diabetes Mellitus, Type 2 and Depression, run by National Cheng-Kung University Hospital.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Depression
- What is being tested?
- Minimal psychological intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Diabetes disease
Who cannot join
- 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
About this study
Official title: The Long-term Effect of a Minimal Psychological Intervention on Type 2 Diabetes Patients' Depressive Symptom, Diabetes-related Distress and Glycemic Control
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.
- Conditions
- Diabetes Mellitus, Type 2, Depression
- Being tested
- Minimal psychological intervention, Usual care
- Keywords
- Type 2 diabetes, Minimal psychological intervention, Glycemic control, Depressive symptoms, Problem Area in Diabetes, Middle-aged and older adults, HbA1c protein, human
- Medical subject headings
- Diabetes Mellitus, Type 2, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal psychological interventionBehavioural
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 careOther
Usual care was given by their family physicians.
| Study group | Role | What they receive |
|---|---|---|
| Minimal Psychological Intervention | Experimental | 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. Receives: Behavioral: Minimal psychological intervention; Other: Usual care |
| Usual care | Other | Participants in this group received usual care only. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Measured: Participants were measured during entire follow-up period, an average period of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Ching-Ju Chiu, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473081
- Sponsor's protocol ID
- NSC 101-2314-B-006-001-
- Status last verified
- Jun 2015
- First submitted
- 9 Jun 2015
- Last updated
- 16 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Effect of a Minimal Psychological Intervention on Type 2 Diabetes Patients' Depressive Symptom, Diabetes-related Distress and Glycemic Control
- ClinicalTrials.gov ID
- NCT02473081
- Acronym / sponsor ID
- NSC 101-2314-B-006-001-
- Conditions
- Diabetes Mellitus, Type 2, Depression
- Keywords
- Type 2 diabetes, Minimal psychological intervention, Glycemic control, Depressive symptoms, Problem Area in Diabetes, Middle-aged and older adults, HbA1c protein, human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal Psychological Intervention | Experimental | Behavioral: Minimal psychological intervention, Other: Usual careParticipants 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 | Other | Other: Usual careParticipants in this group received usual care only. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Diabetes disease
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimal psychological interventionMinimal 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. | Behavioural | Minimal Psychological Intervention |
| Usual careUsual care was given by their family physicians. | Other | Minimal Psychological Intervention, Usual care |
Primary outcome
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).
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.
Hemoglobin A1c
Time frame: Participants were measured during entire follow-up period, an average period of 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal psychological intervention in people with Diabetes Mellitus, Type 2 and Depression, run by National Cheng-Kung University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.