Supporting Treatment Adherence Needs in Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-09-30

Brief Summary

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There is an unmet treatment need for depressed adolescents with type 1 diabetes. To address this unmet need, we have designed a new, family-based, cognitive-behavioral intervention to reduce depressive symptoms, improve family functioning, and improve medication compliance. The intervention is delivered in two phases (1 - reduction of depressive symptoms and family conflict, 2 - adherence promotion) as efforts to improve adherence will have a greater likelihood of success if individual and family functioning variables are addressed first. To test the effectiveness of this intervention in reducing depressive symptoms and improving adherence, we will conduct a randomized controlled trial comparing this new intervention to usual care in a sample of fifty-two adolescents with type 1 diabetes and their primary caregivers. Given the absence of this type of intervention and the significance of the problem, this study is timely and important, as it has the potential to positively impact diabetes-specific health outcomes.

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Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lifestyle counseling

Group Type EXPERIMENTAL

Family-based cognitive-behavioral treatment

Intervention Type BEHAVIORAL

Participants will engage in ten weekly sessions aimed at improving depressive symptoms and medication compliance via reducing family conflict and improving communication among family members.

Wait list control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Family-based cognitive-behavioral treatment

Participants will engage in ten weekly sessions aimed at improving depressive symptoms and medication compliance via reducing family conflict and improving communication among family members.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 13-17
* Diagnosis of type 1 diabetes according to criteria from the ADA for at least 1 year
* Daily insulin dosing of at least 0.5 units per kilogram per day
* Clinical elevation on the CDI (i.e., score at or above 13)
* Assent to participation in study

Exclusion Criteria

* Other chronic, physical disease or condition except for celiac or thyroid disease
* Diagnosis of major mental disorder (e.g., bipolar disorder, thought disorder, anorexia nervosa)
* Diagnosis of developmental disorder (e.g., mental retardation, autism, Asperger's)
* Current enrollment in psychotherapy specifically targeting depression

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No