Comparison of Behavioral Activation and Antidepressant Medication in the Treatment of Adolescents With Depression
| Status: | Terminated |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 13 - 17 |
| Updated: | 12/22/2017 |
| Start Date: | January 2013 |
| End Date: | March 2014 |
Randomized Trial of Behavioral Activation and Antidepressant Medication in the Treatment of Adolescents With Major Depression
This study focuses on treating adolescents with depression. The study has two main purposes.
The first is to compare a new form of therapy for depression called Behavioral Activation
(BA) to the antidepressant medication fluoxetine. BA therapy helps depressed people get more
involved in activities they find enjoyable, which can reduce symptoms of depression. Research
shows that both BA and fluoxetine work to reduce depressive symptoms in adolescents. However,
unlike previous research, this study examines how well the two treatment options work in
comparison to each other. Participants in the study are randomized to receive treatment with
either BA or fluoxetine for 18 weeks.
The second aim of the study is to examine the brain functions of adolescents in both
treatment groups. Participants undergo functional Magnetic Resonance Imaging (fMRI) scans
before and after treatment. The data from these scans will be used to compare the brains of
participants in the BA condition with those in the fluoxetine condition. Also, the scans may
show possible differences between participants' brains before and after treatment. These data
may help scientists determine the ideal form of depression treatment for different types of
people.
The first is to compare a new form of therapy for depression called Behavioral Activation
(BA) to the antidepressant medication fluoxetine. BA therapy helps depressed people get more
involved in activities they find enjoyable, which can reduce symptoms of depression. Research
shows that both BA and fluoxetine work to reduce depressive symptoms in adolescents. However,
unlike previous research, this study examines how well the two treatment options work in
comparison to each other. Participants in the study are randomized to receive treatment with
either BA or fluoxetine for 18 weeks.
The second aim of the study is to examine the brain functions of adolescents in both
treatment groups. Participants undergo functional Magnetic Resonance Imaging (fMRI) scans
before and after treatment. The data from these scans will be used to compare the brains of
participants in the BA condition with those in the fluoxetine condition. Also, the scans may
show possible differences between participants' brains before and after treatment. These data
may help scientists determine the ideal form of depression treatment for different types of
people.
Depression is a serious diagnosis that can have severe consequences; it is not just
experiencing "the blues" or having sad feelings that most people get from time to time.
People who are diagnosed with depression have overwhelming feelings of sadness that are
present for at least two weeks. In addition, they also experience symptoms such as changes in
their appetite or sleep patterns, feelings of guilt or worthlessness, lack of energy or
motivation, and even thoughts of suicide. People with depression have difficulty functioning
in many areas of their lives, including at work, at school, and in social relationships.
Those who have this diagnosis often need medication, therapy, or a combination of both to
relieve their symptoms and regain their usual functioning.
This study investigates whether a type of psychotherapy called Behavioral Activation (BA) is
as effective as antidepressant medication in the treatment of adolescents diagnosed with
depression. In this study, BA is compared to fluoxetine, which is known to help treat
depressive symptoms in this population. BA has been shown to be efficacious in reducing
depression in adolescents, but it is not yet known how it compares to another leading
treatment for depression in this age group. Thus, this study's primary goal is to see how BA
compares to fluoxetine.
This study also examines brain activity as it relates to depression and treatment. The study
includes functional Magnetic Resonance Imaging (fMRI) scans of participants in both
conditions before and after they undergo treatment. Participants play a game in the scanner
called the Monetary Incentive Delay (MID) task, and they have the opportunity to win money
(reward) or to avoid losing money (loss). After they play the MID game, the scan images show
certain brain regions that are activated in reward and loss situations. This study looks at
how these brain regions relate to treatment response, especially because the goal of BA is to
help people enjoy rewards more. The study also compares brain activity between the two
treatment groups, as well as changes in brain activity from pre- to post-treatment. This part
of the study should provide information about which kinds of people respond to which kinds of
treatment.
Behavioral activation is a new therapy that has been shown to successfully treat depressed
adults and adolescents. BA is a type of therapy that helps depressed people get involved in
activities that they find to be enjoying and rewarding. The developers of this therapy
believe that people are depressed because they are not experiencing rewarding and positive
events in their lives very often. For example, when people become depressed, they usually
become isolated from others. They also stop doing the things they used to enjoy, or they do
them far less often. As a result, they have fewer experiences that make them feel a sense of
accomplishment and happiness, and their depression becomes more severe. The worse the
symptoms get, the less they engage in rewarding activities. The developers of BA have
established a therapy program that helps the patient choose and participate in activities
that are rewarding. The therapist acts as a coach, monitoring progress and giving feedback
about these activities and the relationship between this activation and mood. This type of
therapy is not just designed to get depressed people to do more; rather, time is spent
choosing and evaluating specific activities that are particularly rewarding for the client
and evaluating the outcome of these activities. Although BA is a novel intervention, early
evidence shows that BA is effective with regard to alleviating symptoms of depression. In
addition, the results of these studies show that it works in a relatively short amount of
time (approximately four months).
Because so little is known about effective psychosocial treatments for depressed adolescents,
and because of the risks associated with treating adolescents with medications, it is
important to work on developing and supporting new treatments for this at-risk population.
The aim of this pilot study is to generate knowledge for both the scientific community and
for clinicians by gaining new insight into what works for depressed teens. To accomplish
these goals, this study will treat 20 adolescents who meet criteria for Major Depressive
Disorder with 18 weeks of therapy or medication. Ten adolescents will be assigned to the BA
condition, and 10 will be assigned to the fluoxetine condition. Those in the medication
condition will visit with their psychiatrist regularly but will not receive psychotherapy.
Those who receive BA will receive between 18 and 20 sessions of therapy.
It is important to note that people are experiencing first episodes of depression at younger
and younger ages; hence, rates of depression are rising in younger age groups. Also, suicide
is the third leading cause of death among adolescents, and depression is associated with
increased thoughts of suicide and suicide attempts. Depressed children and adolescents are
more likely to develop a host of other problems, such as substance abuse, and they are more
likely to report experiencing stressful life events. For all these reasons, it is important
that scientists work to develop therapies that relieve depression in this population. Studies
such as this one can help advance knowledge about how best to treat this dangerous illness.
experiencing "the blues" or having sad feelings that most people get from time to time.
People who are diagnosed with depression have overwhelming feelings of sadness that are
present for at least two weeks. In addition, they also experience symptoms such as changes in
their appetite or sleep patterns, feelings of guilt or worthlessness, lack of energy or
motivation, and even thoughts of suicide. People with depression have difficulty functioning
in many areas of their lives, including at work, at school, and in social relationships.
Those who have this diagnosis often need medication, therapy, or a combination of both to
relieve their symptoms and regain their usual functioning.
This study investigates whether a type of psychotherapy called Behavioral Activation (BA) is
as effective as antidepressant medication in the treatment of adolescents diagnosed with
depression. In this study, BA is compared to fluoxetine, which is known to help treat
depressive symptoms in this population. BA has been shown to be efficacious in reducing
depression in adolescents, but it is not yet known how it compares to another leading
treatment for depression in this age group. Thus, this study's primary goal is to see how BA
compares to fluoxetine.
This study also examines brain activity as it relates to depression and treatment. The study
includes functional Magnetic Resonance Imaging (fMRI) scans of participants in both
conditions before and after they undergo treatment. Participants play a game in the scanner
called the Monetary Incentive Delay (MID) task, and they have the opportunity to win money
(reward) or to avoid losing money (loss). After they play the MID game, the scan images show
certain brain regions that are activated in reward and loss situations. This study looks at
how these brain regions relate to treatment response, especially because the goal of BA is to
help people enjoy rewards more. The study also compares brain activity between the two
treatment groups, as well as changes in brain activity from pre- to post-treatment. This part
of the study should provide information about which kinds of people respond to which kinds of
treatment.
Behavioral activation is a new therapy that has been shown to successfully treat depressed
adults and adolescents. BA is a type of therapy that helps depressed people get involved in
activities that they find to be enjoying and rewarding. The developers of this therapy
believe that people are depressed because they are not experiencing rewarding and positive
events in their lives very often. For example, when people become depressed, they usually
become isolated from others. They also stop doing the things they used to enjoy, or they do
them far less often. As a result, they have fewer experiences that make them feel a sense of
accomplishment and happiness, and their depression becomes more severe. The worse the
symptoms get, the less they engage in rewarding activities. The developers of BA have
established a therapy program that helps the patient choose and participate in activities
that are rewarding. The therapist acts as a coach, monitoring progress and giving feedback
about these activities and the relationship between this activation and mood. This type of
therapy is not just designed to get depressed people to do more; rather, time is spent
choosing and evaluating specific activities that are particularly rewarding for the client
and evaluating the outcome of these activities. Although BA is a novel intervention, early
evidence shows that BA is effective with regard to alleviating symptoms of depression. In
addition, the results of these studies show that it works in a relatively short amount of
time (approximately four months).
Because so little is known about effective psychosocial treatments for depressed adolescents,
and because of the risks associated with treating adolescents with medications, it is
important to work on developing and supporting new treatments for this at-risk population.
The aim of this pilot study is to generate knowledge for both the scientific community and
for clinicians by gaining new insight into what works for depressed teens. To accomplish
these goals, this study will treat 20 adolescents who meet criteria for Major Depressive
Disorder with 18 weeks of therapy or medication. Ten adolescents will be assigned to the BA
condition, and 10 will be assigned to the fluoxetine condition. Those in the medication
condition will visit with their psychiatrist regularly but will not receive psychotherapy.
Those who receive BA will receive between 18 and 20 sessions of therapy.
It is important to note that people are experiencing first episodes of depression at younger
and younger ages; hence, rates of depression are rising in younger age groups. Also, suicide
is the third leading cause of death among adolescents, and depression is associated with
increased thoughts of suicide and suicide attempts. Depressed children and adolescents are
more likely to develop a host of other problems, such as substance abuse, and they are more
likely to report experiencing stressful life events. For all these reasons, it is important
that scientists work to develop therapies that relieve depression in this population. Studies
such as this one can help advance knowledge about how best to treat this dangerous illness.
Inclusion Criteria:
- Male and female adolescents ages 13-17
- Current diagnosis of Major Depressive Disorder as determined by the Kiddie Schedule
for Affective Disorders and Schizophrenia (KSADS-PL), Children's Depression Rating
Scale (CDRS-R) raw score > 45 (T-score > 65) at baseline
- Estimated full scale IQ > 80 as determined by the Wechsler Intelligence Scale for
Children (WISC)
- Able to receive outpatient care
- Willing to discontinue other psychosocial treatments
- Not taking psychotropic medications in the one month prior to consent, with the
exception of psychostimulant medication prescribed for the treatment of
attention-deficit/hyperactivity disorder (ADHD)
Exclusion Criteria:
- Current or past diagnosis of bipolar, schizophrenia, schizophreniform, schizoaffective
disorders, or psychosis not otherwise specified
- Current diagnosis of developmental disorder, severe conduct disorder, life-threatening
anorexia, obsessive-compulsive disorder, or autism-spectrum disorders
- Taking psychotropic medications prior to entry
- Estimated IQ < 80
- Alcohol/drug dependence or abuse within the last 3 months
- Potential/confirmed neurological disorder or epilepsy
- Claustrophobia
- Presence of a medical condition that precludes fMRI
- Endorsement of imminent and serious suicidality
- Medical conditions for which treatment with fluoxetine is contraindicated or that take
precedence over the presence of major depressive disorder (MDD)
- Pregnancy
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