DepressionPhase 1NCT01128764
Integrated Treatment for Comorbid Depression and Obesity in Adolescents
A Phase 1 study testing CBT for depression and healthy lifestyle plus exercise and CBT for depression in people with Depression and Overweight, run by Brown University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depression, Overweight
- What is being tested?
- CBT for depression and healthy lifestyle plus exercise and CBT for depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 -
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Depression, Overweight
- Being tested
- CBT for depression and healthy lifestyle plus exercise, CBT for depression
- Medical subject headings
- Depression, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT for depression and healthy lifestyle plus exerciseBehavioural
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.
CBT for depressionBehavioural
Standard CBT treatment for depressed teens that addresses depression using CBT techniques only
| Study group | Role | What they receive |
|---|---|---|
| CBT for depression and healthy lifestyle plus exercise | Experimental | 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. Receives: Behavioral: CBT for depression and healthy lifestyle plus exercise |
| CBT for depression | Active comparator | CBT for depression only Receives: Behavioral: CBT for depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
depressed mood
Measured: baseline, posttreatment , 6 month follow-up
Secondary outcomes (1)
weight
Measured: baseline, posttreatment, 6 month foll-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startDec 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Anthony Spirito, National Institute of Mental Health (NIMH)
- Investigators
- Anthony Spirito, PhD, Principal investigator, Brown UniversityElissa Jelalian, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128764
- Sponsor's protocol ID
- R34MH083092
- Other IDs
- R34MH083092
- Status last verified
- Jul 2014
- First submitted
- 21 May 2010
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jelalian E, Jandasek B, Wolff JC, Seaboyer LM, Jones RN, Spirito A. Cognitive-Behavioral Therapy Plus Healthy Lifestyle Enhancement for Depressed, Overweight/Obese Adolescents: Results of a Pilot Trial. J Clin Child Adolesc Psychol. 2019;48(sup1):S24-S33. doi: 10.1080/15374416.2016.1163705. Epub 2016 Jun 16.
PubMed 27310418
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Treatment for Comorbid Depression and Obesity in Adolescents
- ClinicalTrials.gov ID
- NCT01128764
- Acronym / sponsor ID
- R34MH083092
- Conditions
- Depression, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT for depression and healthy lifestyle plus exercise | Experimental | Behavioral: CBT for depression and healthy lifestyle plus exerciseCBT 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. |
| CBT for depression | Active comparator | Behavioral: CBT for depressionCBT for depression only |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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 -
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT for depression and healthy lifestyle plus exerciseCBT 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. | Behavioural | CBT for depression and healthy lifestyle plus exercise |
| CBT for depressionStandard CBT treatment for depressed teens that addresses depression using CBT techniques only | Behavioural | CBT for depression |
Primary outcome
depressed mood
Time frame: baseline, posttreatment , 6 month follow-up
1 secondary outcome
weight
Time frame: baseline, posttreatment, 6 month foll-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
- Derived from this study: PubMed 27310418Jelalian E, Jandasek B, Wolff JC, Seaboyer LM, Jones RN, Spirito A. Cognitive-Behavioral Therapy Plus Healthy Lifestyle Enhancement for Depressed, Overweight/Obese Adolescents: Results of a Pilot Trial. J Clin Child Adolesc Psychol. 2019;48(sup1):S24-S33. doi: 10.1080/15374416.2016.1163705. Epub 2016 Jun 16.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Spirito, PhD principal investigator
Brown University
Elissa Jelalian, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBT for depression and healthy lifestyle plus exercise and CBT for depression in people with Depression and Overweight, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depressed mood (time frame: baseline, posttreatment , 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01128764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2014.