A Pychoeducational Intervention for Women With Diabetes

NCT01185561 | Completed Results DMC

• 1 other identifier: 108324
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Depression; Anxiety; Anger

Keywords

Diabetes; SWEEP; Dysphoria

Outcome Measures

Primary Outcomes (1)

• 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.

  6 Months

Secondary Outcomes (3)

• State-Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test Score

  6 Months

• State-Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test Score

  6 Months

• State-Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test Score

  6 Months

Study Arms (2)

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

Behavioral: Psychoeducational intervention

Interventions

Psychoeducational intervention BEHAVIORAL

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.

Psychoeducational intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

There are no limitations or caveats to report.

Results Point of Contact

• Title: Sue Penckofer, Ph.D.
• Organization: Loyola University

spencko@luc.edu

708-216-9303

Study Officials

• Sue Penckofer, PhD

  Loyola University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: August 20, 2010
• Study Start: March 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 14, 2016
• Results First Posted: December 14, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)