Integrated Treatment for Comorbid Depression and Obesity in Adolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anthony Spirito, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT01128764
First received: May 21, 2010
Last updated: July 28, 2014
Last verified: July 2014
  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.


Condition Intervention Phase
Depression
Overweight
Behavioral: CBT for depression and healthy lifestyle plus exercise
Behavioral: CBT for depression
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Integrated Treatment for Comorbid Depression and Obesity in Adolescents

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • depressed mood [ Time Frame: baseline, posttreatment , 6 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • weight [ Time Frame: baseline, posttreatment, 6 month foll-up ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: December 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT for depression and healthy lifestyle plus exercise
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.
Behavioral: CBT for depression and healthy lifestyle plus exercise
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.
Active Comparator: CBT for depression
CBT for depression only
Behavioral: CBT for depression
Standard CBT treatment for depressed teens that addresses depression using CBT techniques only

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01128764

Locations
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Anthony Spirito, PhD Brown University
Principal Investigator: Elissa Jelalian, PhD Brown University
  More Information

No publications provided

Responsible Party: Anthony Spirito, Professor, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT01128764     History of Changes
Other Study ID Numbers: R34 MH083092, R34MH083092
Study First Received: May 21, 2010
Last Updated: July 28, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Overweight
Behavioral Symptoms
Mood Disorders
Mental Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014