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Integrated Treatment for Comorbid Depression and Obesity in Adolescents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01128764
First Posted: May 24, 2010
Last Update Posted: July 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Anthony Spirito, National Institute of Mental Health (NIMH)
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Anthony Spirito, National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • depressed mood [ Time Frame: baseline, posttreatment , 6 month follow-up ]

Secondary Outcome Measures:
  • weight [ Time Frame: baseline, posttreatment, 6 month foll-up ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128764


Locations
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Anthony Spirito, PhD Brown University
Principal Investigator: Elissa Jelalian, PhD Brown University
  More Information

Responsible Party: Anthony Spirito, Professor, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT01128764     History of Changes
Other Study ID Numbers: R34MH083092 ( U.S. NIH Grant/Contract )
First Submitted: May 21, 2010
First Posted: May 24, 2010
Last Update Posted: July 29, 2014
Last Verified: July 2014

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


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