DepressionSWEEPNCT01185561
A Pychoeducational Intervention for Women With Diabetes
A study testing Psychoeducational intervention in people with Depression and Anxiety, run by Loyola University at 1 site in United States.
Trial summary
This proposal describes a small randomized study to determine whether usual medical care (UMC) for diabetes combined with a psychoeducational program is more effective than UMC for diabetes alone. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Depression, Anxiety, Anger
- What is being tested?
- Psychoeducational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Nov 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 to 75 years;
- have type 2 diabetes greater than six months and being medically managed
- score greater than or equal to 16 on the Center for Epidemiological Studies Depression (CES-D) scale which is indicative of depressive symptoms.
- score greater than or equal to 12 on the CES-D plus a history of depression or currently being treated for depression.
Who cannot join
- Women with current alcohol or substance abuse disorders, or a history of bipolar depression or any other psychotic disorder will be excluded.
- Women will also be excluded if they have a diabetes knowledge test score of less than 70% and severe complications of diabetes (blindness, renal failure, or major amputation which includes most toes, foot, knee, or leg)
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
This proposal describes a small randomized study to determine whether usual medical care (UMC) for diabetes combined with a psychoeducational program is more effective than UMC for diabetes alone. This program differs from other diabetes programs by focusing on the management of dysphoric symptoms (depressive symptoms, anxiety, and anger). Diabetes self-care behaviors will be discussed and measured, but they are not the primary focus of the intervention. The psychoeducational program will address: 1) education about how dysphoric symptoms affect glycemic control; 2) recognition of dysphoric symptoms; and 3) management of dysphoric symptoms using Cognitive Behavioral Therapy (CBT). Subjects will be randomized to receive the group psychoeducational intervention or no additional treatment. All subjects will receive UMC for diabetes.
Read the detailed description
Diabetes is the fifth deadliest disease in the United States with no known cure, and cardiovascular disease (CVD) is the leading cause of death in persons with diabetes. Diabetes is the only disease that causes women to have as much heart disease as men. The relative risk of cardiac mortality has been reported to be 2.6 for women with diabetes as compared to 1.9 for men with diabetes after controlling for other cardiac risk factors. While cardiac mortality for men with diabetes has declined (13.1%), there has been a 23% increase in age-adjusted cardiac mortality for women with diabetes. This poor outcome, occurring in a time of significant advances in the management of heart disease, suggests the need to consider directing treatment at other risk factors. Depression may be one such risk factor.
Depression is an independent risk factor for CVD, and is associated with poorer self-management and decreased health-related quality of life. Approximately 25% of persons with diabetes have depression, and the rate of depression in women with diabetes is double that of men with diabetes. Women with diabetes exhibit worse diabetes self-care, glycemic control, and poorer quality of life than men with diabetes, which are exacerbated by depression. Other affective symptoms including anxiety and anger commonly accompany depressive symptoms appear to impose similar risks for poor medical outcomes, and occur more often in women with diabetes than men with diabetes.
Research has shown that treatment of depression with medication and/or cognitive behavioral therapy (CBT) effectively relieves depression and improves glycemic control in persons with diabetes. More recent evidence suggests that these benefits are more durable in patients treated with CBT vs. antidepressants alone. There has been no research on "symptom clusters" (i.e., depression, anxiety, and anger) in persons with diabetes, and their effect on glycemic control and self-management. In addition, a CBT program to treat a cluster of dysphoric symptoms has not been tested in persons with diabetes. Since women with diabetes have greater depression and anxiety, worse glycemic control, and increased cardiac mortality than men with diabetes, we are proposing to test the feasibility and effectiveness of a psychoeducational intervention to promote emotional health in women with type 2 diabetes.
This proposal describes a small randomized controlled trial to determine whether usual medical care (UMC) for diabetes combined with a psychoeducational program is more effective than UMC for diabetes alone. This program differs from other diabetes programs by focusing on the management of dysphoric symptoms (depressive symptoms, anxiety, and anger). Diabetes self-care behaviors will be discussed and measured, but they are not the primary focus of the intervention. The psychoeducational program will address: 1) education about how dysphoric symptoms affect glycemic control; 2) recognition of dysphoric symptoms; and 3) management of dysphoric symptoms using CBT. A repeated measures, experimental design will be used. Subjects will be randomized to receive the group psychoeducational intervention or no additional treatment. All subjects will receive UMC for diabetes. The aims and hypotheses for the study are:
Primary Aim: To determine the effect of a psychoeducational intervention on dysphoric symptoms. The primary hypothesis is that women receiving a psychoeducational intervention plus UMC will report fewer dysphoric symptoms (depression, anxiety, and anger) at three and six months follow-up.
Secondary Aim: To determine the effect of a psychoeducational intervention on glycemic control, diabetes self-management, and health-related quality of life. The secondary hypothesis is that women receiving a psychoeducational intervention plus UMC will have decreased hemoglobin A1c, report better diabetes self-management (increased self-care behaviors and self-efficacy), and report increased health-related quality of life (increased functional status, life satisfaction, and decreased diabetes-related distress) at three and six months follow-up.
- Conditions
- Depression, Anxiety, Anger
- Being tested
- Psychoeducational intervention
- Keywords
- Diabetes, SWEEP, Dysphoria
- Medical subject headings
- Depression, Anxiety Disorders, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational interventionBehavioural
The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.
| Study group | Role | What they receive |
|---|---|---|
| Usual medical care | No intervention | Participants assigned to this arm represent the control group and will receive usual medical care only. |
| Psychoeducational intervention | Experimental | Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes Receives: Behavioral: Psychoeducational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiologic Studies Depression (CES-D) Score
The CES-D score was compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The CES-D is a self-report questionnaire assessing frequency and severity of depression symptoms. Scores may range from 0 to 60, where higher scores indicate worse mood.
Measured: 6 Months
Secondary outcomes (3)
State-Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test Score
Scores on the The State-Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test are compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAI state anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.
Measured: 6 Months
State-Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test Score
Scores on the The State-Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test are compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAI trait anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.
Measured: 6 Months
State-Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test Score
Scores on the The State-Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test will be compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAXI anger expression subtest is a 24-item scale measuring how anger is generally being experienced and expressed. Scores may range from 0 to 72 with higher scores indicating greater anger.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startMar 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sue Penckofer, Loyola University
- Investigators
- Sue Penckofer, PhD, Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185561
- Sponsor's protocol ID
- 108324
- Acronym
- SWEEP
- Status last verified
- Oct 2016
- First submitted
- 18 Aug 2010
- Last updated
- 14 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pychoeducational Intervention for Women With Diabetes
- ClinicalTrials.gov ID
- NCT01185561
- Acronym / sponsor ID
- SWEEP / 108324
- Conditions
- Depression, Anxiety, Anger
- Keywords
- Diabetes, SWEEP, Dysphoria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 20 Aug 2010 (estimated)
- Results
- Posted 14 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal describes a small randomized study to determine whether usual medical care (UMC) for diabetes combined with a psychoeducational program is more effective than UMC for diabetes alone. This program differs from other diabetes programs by focusing on the management of dysphoric symptoms (depressive symptoms, anxiety, and anger). Diabetes self-care behaviors will be discussed and measured, but they are not the primary focus of the intervention. The psychoeducational program will address: 1) education about how dysphoric symptoms affect glycemic control; 2) recognition of dysphoric symptoms; and 3) management of dysphoric symptoms using Cognitive Behavioral Therapy (CBT). Subjects will be randomized to receive the group psychoeducational intervention or no additional treatment. All subjects will receive UMC for diabetes.
Detailed description
Diabetes is the fifth deadliest disease in the United States with no known cure, and cardiovascular disease (CVD) is the leading cause of death in persons with diabetes. Diabetes is the only disease that causes women to have as much heart disease as men. The relative risk of cardiac mortality has been reported to be 2.6 for women with diabetes as compared to 1.9 for men with diabetes after controlling for other cardiac risk factors. While cardiac mortality for men with diabetes has declined (13.1%), there has been a 23% increase in age-adjusted cardiac mortality for women with diabetes. This poor outcome, occurring in a time of significant advances in the management of heart disease, suggests the need to consider directing treatment at other risk factors. Depression may be one such risk factor.
Depression is an independent risk factor for CVD, and is associated with poorer self-management and decreased health-related quality of life. Approximately 25% of persons with diabetes have depression, and the rate of depression in women with diabetes is double that of men with diabetes. Women with diabetes exhibit worse diabetes self-care, glycemic control, and poorer quality of life than men with diabetes, which are exacerbated by depression. Other affective symptoms including anxiety and anger commonly accompany depressive symptoms appear to impose similar risks for poor medical outcomes, and occur more often in women with diabetes than men with diabetes.
Research has shown that treatment of depression with medication and/or cognitive behavioral therapy (CBT) effectively relieves depression and improves glycemic control in persons with diabetes. More recent evidence suggests that these benefits are more durable in patients treated with CBT vs. antidepressants alone. There has been no research on "symptom clusters" (i.e., depression, anxiety, and anger) in persons with diabetes, and their effect on glycemic control and self-management. In addition, a CBT program to treat a cluster of dysphoric symptoms has not been tested in persons with diabetes. Since women with diabetes have greater depression and anxiety, worse glycemic control, and increased cardiac mortality than men with diabetes, we are proposing to test the feasibility and effectiveness of a psychoeducational intervention to promote emotional health in women with type 2 diabetes.
This proposal describes a small randomized controlled trial to determine whether usual medical care (UMC) for diabetes combined with a psychoeducational program is more effective than UMC for diabetes alone. This program differs from other diabetes programs by focusing on the management of dysphoric symptoms (depressive symptoms, anxiety, and anger). Diabetes self-care behaviors will be discussed and measured, but they are not the primary focus of the intervention. The psychoeducational program will address: 1) education about how dysphoric symptoms affect glycemic control; 2) recognition of dysphoric symptoms; and 3) management of dysphoric symptoms using CBT. A repeated measures, experimental design will be used. Subjects will be randomized to receive the group psychoeducational intervention or no additional treatment. All subjects will receive UMC for diabetes. The aims and hypotheses for the study are:
Primary Aim: To determine the effect of a psychoeducational intervention on dysphoric symptoms. The primary hypothesis is that women receiving a psychoeducational intervention plus UMC will report fewer dysphoric symptoms (depression, anxiety, and anger) at three and six months follow-up.
Secondary Aim: To determine the effect of a psychoeducational intervention on glycemic control, diabetes self-management, and health-related quality of life. The secondary hypothesis is that women receiving a psychoeducational intervention plus UMC will have decreased hemoglobin A1c, report better diabetes self-management (increased self-care behaviors and self-efficacy), and report increased health-related quality of life (increased functional status, life satisfaction, and decreased diabetes-related distress) at three and six months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual medical care | No intervention | –Participants assigned to this arm represent the control group and will receive usual medical care only. |
| Psychoeducational intervention | Experimental | Behavioral: Psychoeducational interventionParticipants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 18 to 75 years;
- have type 2 diabetes greater than six months and being medically managed
- score greater than or equal to 16 on the Center for Epidemiological Studies Depression (CES-D) scale which is indicative of depressive symptoms.
- score greater than or equal to 12 on the CES-D plus a history of depression or currently being treated for depression.
Key exclusion criteria (2 listed)
- Women with current alcohol or substance abuse disorders, or a history of bipolar depression or any other psychotic disorder will be excluded.
- Women will also be excluded if they have a diabetes knowledge test score of less than 70% and severe complications of diabetes (blindness, renal failure, or major amputation which includes most toes, foot, knee, or leg)
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 |
|---|---|---|
| Psychoeducational interventionThe intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills. | Behavioural | Psychoeducational intervention |
Primary outcome
Center for Epidemiologic Studies Depression (CES-D) Score
Time frame: 6 Months
The CES-D score was compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The CES-D is a self-report questionnaire assessing frequency and severity of depression symptoms. Scores may range from 0 to 60, where higher scores indicate worse mood.
3 secondary outcomes
State-Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test Score
Time frame: 6 Months
State-Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test Score
Time frame: 6 Months
State-Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test Score
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sue Penckofer, PhD principal investigator
Loyola University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational intervention in people with Depression and Anxiety, run by Loyola University at 1 site in United States.
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 4 inclusion and 2 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 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 14 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Center for Epidemiologic Studies Depression (CES-D) Score (time frame: 6 Months). 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 14 Dec 2016; AzTrials last refreshed its copy on 6 Nov 2026.