Expired Study
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Providence, Rhode Island 02912


Purpose:

Lifetime prevalence of major depression is estimated at 28% by age 18 (Lewinsohn et al., 1999), with higher cumulative rates in females (35%) than males (19%). Approximately 17% of children and adolescents in the United States are obese as defined by a BMI above the 95th percentile, with more than 30% falling between the 85th and 95th percentiles (Ogden et al., 2008). Overweight children and adolescents are at increased risk for type 2 diabetes (Pinhas-Hamiel et al., 1996) and overwhelming risk for adult obesity (Guo et al., 1994). There is a substantial percentage of adolescents who are both overweight and depressed with estimates from clinical samples averaging 25%. Treatment of teens with comorbid medical and psychiatric conditions such as overweight/obesity and depression has received little to no attention in the psychosocial treatment research literature. Due to the large number of adolescents who are both depressed and overweight, developing a behavioral treatment that addresses both problems simultaneously has important public health significance. The purpose of this proposal is to combine treatments for depression and overweight to address these co-occurring conditions in one intervention. The long-term objectives of this research are to develop efficient and effective treatments for co-occurring physical and emotional disorders. The research program will be divided into 3 major phases: a development phase (Stage 1a), a pilot study phase (Stage 1b), and a revision phase. During the development phase (Stage 1a), a treatment for overweight teens and CBT treatment for depressed teens will be adapted into one integrated protocol that addresses depression using CBT techniques, an exercise component, and advice regarding healthy eating. As part of this phase, we will adapt existing intervention manuals and therapist training materials, and gain some initial clinical experience with the intervention via an open trial with 6 teens. During the randomized pilot study phase (Stage 1b), the integrated intervention will be compared to a control group receiving CBT treatment for depression alone (N=40 in total). During the pilot phase, the feasibility and acceptability of administering the program will be assessed. In addition, we will compare change in depressed mood at end of treatment and 6 month follow-up periods across the two groups. During the revision phase, the intervention manual will be further developed and refined, based on experiences and observations made during the development and pilot study phases.


Criteria:

Inclusion Criteria: Adolescents must: 1) be between the ages of 12 and 18 years (18 year olds must still be in high school and living at home); 2) be at or above the 85th percentile with reference to age and gender-specific Body Mass Index (BMI); 3) have at least one parent available to participate in the treatment protocol; 4) speak English; 5) agree to study participation and random assignment; and 6) be available for follow-up. In order to meet the depressed mood criterion, adolescents must have a primary diagnosis of major depressive disorder (single or recurrent), based on the KSADS-PL with a CGI-Severity ≥ 3 for depression and CDRS ≥ 36. Participants must be healthy, as established by their primary care physician, in order to participate in the exercise program - Exclusion Criteria: Adolescents will be excluded if: 1) they are currently receiving psychotherapy or participating in another weight loss program (only can have been in a weight loss program in the past); 2) they have a medical condition that would interfere with the prescribed dietary plan or participation in physical activity; 3) they are developmentally delayed such that the intervention materials will not be appropriate; 4) they are actively suicidal at intake; 5) they have not been on a stable dose of a psychostimulant for 6 months to ensure that a recently prescribed psychostimulant is not contributing to weight loss; 6) teens on an SSRI will not be allowed to participate due to potential effects of medication on weight loss; 7) they have a substance abuse or dependence diagnosis; or 8) they have failed a medication or psychotherapy trial for depression in the past.


Study is Available At:


Original ID:

R34 MH083092


NCT ID:

NCT01128764


Secondary ID:

R34MH083092


Study Acronym:


Brief Title:

Integrated Treatment for Comorbid Depression and Obesity in Adolescents


Official Title:

Integrated Treatment for Comorbid Depression and Obesity in Adolescents


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

12 Years


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Brown University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

36


Enrollment Type:

Actual


Overall Contact Information

Official Name:Anthony Spirito, PhD
Principal Investigator
Brown University

Study Dates

Start Date:December 2009
Completion Date:December 2013
Completion Type:Actual
Primary Completion Date:December 2013
Primary Completion Type:Actual
Verification Date:July 2014
Last Changed Date:July 28, 2014
First Received Date:May 21, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:depressed mood
Time Frame:baseline, posttreatment , 6 month follow-up
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:weight
Time Frame:baseline, posttreatment, 6 month foll-up
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:CBT for depression
Description:Standard CBT treatment for depressed teens that addresses depression using CBT techniques only
Arm Name:CBT for depression
Intervention Type:Behavioral
Name:CBT for depression and healthy lifestyle plus exer
Description:CBT treatment for depressed teens will be adapted into one integrated protocol that addresses depression using CBT techniques, an exercise component, and advice regarding healthy eating.
Arm Name:CBT for depression and healthy lifestyle plus exer

Study Arms

Study Arm Type:Active Comparator
Arm Name:CBT for depression
Description:CBT for depression only
Study Arm Type:Experimental
Arm Name:CBT for depression and healthy lifestyle plus exercise
Description:CBT treatment for depressed teens will be adapted into one integrated protocol that addresses depression using CBT techniques, an exercise component, and advice regarding healthy eating.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Brown University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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