Please select the eligibility criteria that correspond to the clinical trial below.
Title: Integrated Treatment for Comorbid Depression and Obesity in Adolescents
Brief Summary: 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.


Options:
A: Inclusion Criteria:

* Adolescents 13-16 years old
* 20-90% overweight with reference gender and age
* At least 1 parent who can participate
* English speaking
* Agree to study participation and random assignment
* Be available for long-term follow-up

Exclusion Criteria:

* Current involvement in another weight loss program
* Unable to adhere to prescribed dietary plan and physical activity due to medical condition
* Unable to understand intervention materials
* In treatment for or diagnosed with psychiatric disorder
B: 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.
C: Inclusion Criteria:

Criteria for participation in the study include:

* Being overweight (BMI \> 85th percentile for age and sex, weight for height \>85th percentile, or weight \>120% of ideal for height). In addition, at least half of the study participants will have a BMI \> 95th percentile for age and sex. Study participants will have a maximum body weight of 285 pounds.
* Adolescent subjects must also have at least two of the following risk factors:

  * family history of type 2 diabetes in a first-or second-degree relative,
  * race/ethnicity of American Indian, African-American, Hispanic, Asian/Pacific Islander, or
  * signs of insulin resistance (acanthosis nigricans, hypertension, dyslipidemia, or polycystic ovarian syndrome).
* In addition, adolescent subjects must be able to read and speak English or Spanish, have access to the Internet at home, school, or work, be reachable at a telephone number, be willing to participate in monthly 90-minute group meetings, have plans to stay in the San Diego area for the one-year study period, and have an English or Spanish speaking parent/guardian also willing to participate in the study.
* Parental consent (obtained in parents primary language) and subject assent is also required.
* Participants must have a parent or guardian agree to enroll who is able to speak and read in English or Spanish, has ongoing access and uses the internet, and plans to reside in San Diego for the length of the study.

Exclusion Criteria:

Subjects will be excluded from participation if they have any of the following conditions:

* Diabetes
* Pregnancy
* Cardiovascular problem, musculoskeletal problem or any medical condition that would limit their ability to comply with physical activity or dietary recommendations.
* Patients in foster care will be ineligible due to difficulty in obtaining follow-up measures.
D: Inclusion Criteria:

* patients from POC/HSM
* aged between 12 and 18 years
* BMI percentile ≥ 95th
* internet access at least once a week

Exclusion Criteria:

* presence of severe psychopathology
* inability to communicate in writing
* pregnancy
* having been proposed for bariatric surgery

Answer: B