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Mood and Diabetes Empowerment & Improvement Training (MADE-IT)

27 maggio 2015 aggiornato da: Dr. Jeanne Miranda, University of California, Los Angeles

University of California, Los Angeles (UCLA)/Drew Project EXPORT: Mood and Diabetes Empowerment & Improvement Training (MADE IT)

In this project, investigators examine the impact of a mood treatment enhanced diabetes self-care intervention for depressed, low-income Latino diabetics. The investigators hypothesize that the mood treatment enhancement will lead to significant improvement in both diabetes and depression outcomes as compared with the self-care intervention alone.

Panoramica dello studio

Stato

Completato

Descrizione dettagliata

The Phase I pilot recruited older Latinos from Dr. Mangione's previous study (who agreed to participate in future research) and 10 participants from a community settings. Those with low mood and poor glycemic control were offered a 12-week intervention combining cognitive behavioral therapy mood management techniques and diabetes self-care into one seamless intervention. Drs. Mangione and Miranda supervised and reviewed (through audiotapes) well-trained health educators conducting the intervention sessions. The study manuals were modified following this Phase I pilot intervention.

The final intervention manual was tested in a randomized trial in Phase II, compared the Mood and Diabetes Empowerment and Improvement Training intervention with enhanced care as usual (providing participants with a letter regarding their mood and hemoglobin (Hb)A1c with recommendations for improving care for their provider). The target population was low-income Latinos with depression and poor glycemic control. Both mood and diabetes outcomes are evaluated.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

121

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • California
      • Los Angeles, California, Stati Uniti, 90095
        • UCLA Psychr & Biobehav Sci

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

50 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Latino men and women age 50 and older
  • Must speak English or Spanish
  • Hb A1c greater than or equal to 8%
  • Currently not taking medication for depression
  • A score of 5 or greater on the Geriatric Depression Scale (GDS)

Exclusion Criteria:

  • Persons who are legally blind, dialysis dependent, diagnosed with dementia, and/or with hemiparesis from a cerebral vascular accident
  • Do not have sufficient hearing or cognitive function

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Wait-listed Control Group
Participants in the Wait-listed Control Group will receive augmented access and communication with a primary care provider. The augmentation would consist of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team will also attach a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will also be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
Sperimentale: Empowerment and CBT Classes
Participants will attend weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants will learn cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants will learn a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change "experiments" designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis.
Participants randomized to the intervention arm will receive a manual with 3 CBT modules and 1 Diabetes Empowerment module. CBT Module 1 covers "Understanding Depression and Diabetes", Module 2 "How Thoughts Affect Your Mood and Diabetes Care", Module 3 "How Activities Affect Your Mood and Diabetes Care". The Diabetes Empowerment Module covers topics including the following: food, exercise, medicine, diabetes and your health, social support, communication skills, and community resources.
Altri nomi:
  • CBT Classes
  • Diabetes Classes

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Hemoglobin A1c at 6 Months
Lasso di tempo: Baseline and 6 months
Hemoglobin A1c (HbA1c) measures glycemic control over the past three months. HbA1c was measured by a blood draw and laboratory test.
Baseline and 6 months
Change From Baseline in Depression Measures at 6 Months
Lasso di tempo: Baseline and 6 months

The Geriatric Depression Scale (GDS) measures depression in older adults. The short form we used consists of 15 yes or no questions. The scale range is 0 to 15, where higher scores indicate greater severity of depression.

The Patient Health Questionnaire-9 (PHQ-9) measures depression in patients. The questionnaire consists of 9 questions where patients self report how frequently they have depression symptoms over the past two weeks. The scale ranges is 0 to 27 where higher scores indicate greater severity of depression.

Baseline and 6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Blood Pressure at 6 Months
Lasso di tempo: Baseline and 6 months
Baseline and 6 months
Change From Baseline in Low Density Lipoprotein-C at 6 Months
Lasso di tempo: Baseline and 6 months
Baseline and 6 months
Change From Baseline in EQ-5D at 6 Months
Lasso di tempo: Baseline and 6 months

The EQ-5D measures general quality of life. The index score is based on 5 questions about mobility, self-care, pain, usual activities, and psychological status. The EuroQol Group provides a U.S. preference-weighted algorithm to calculate the index scores. A score of 1 indicates no problems while a score of -0.11 indicates severe problems.

The scale score is based on a visual analog of a thermostat, where 0 represents worst imaginable health and 100 represents best imaginable health. Patients mark a tick for where they feel their health is on that scale.

Baseline and 6 months
Change From Baseline in Yale Physical Activity Scale - Index Summary Score at 6 Months
Lasso di tempo: Baseline and 6 months
The Yale Physical Activity Scale measures physical function and activities of daily living. Five activity indices (vigorous activity, leisurely walking, moving, standing and sitting) are calculated by multiplying the frequency of activity with the duration and a weighted factor. The 5 indices are then summed to create an index summary. Higher scores indicate more activity. The minimum and maximum scores are 0 and 142.
Baseline and 6 months
Change From Baseline in Self-Efficacy (Diabetes Empowerment Scale) at 6 Months
Lasso di tempo: Baseline and 6 months
The Diabetes Empowerment Scale Short Form (DES-SF) measures diabetes-related psychosocial self-efficacy. The questionnaire presents 8 statements on self-efficacy where participants rate how strongly they agree. The answers are summed to create a score where higher scores indicate more empowerment. The score range is 0 to 8.
Baseline and 6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Jeanne Miranda, PhD, UCLA Psychr & Biobehav Sci

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2009

Completamento primario (Effettivo)

1 gennaio 2012

Completamento dello studio (Effettivo)

1 gennaio 2012

Date di iscrizione allo studio

Primo inviato

1 agosto 2013

Primo inviato che soddisfa i criteri di controllo qualità

9 dicembre 2013

Primo Inserito (Stima)

13 dicembre 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

1 giugno 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 maggio 2015

Ultimo verificato

1 maggio 2015

Maggiori informazioni

Termini relativi a questo studio

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Empowerment and CBT Classes

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