Depression
Conditions
Keywords
Depression, Adolescents, Treatment
Brief summary
Depression in youth is a serious public health concern for which more personalized treatments are needed. This study will test the effect of an intervention aimed at enhancing depressed children's social cognitive capacities (e.g., ability to take another's perspective), thereby making treatment of depression in youth more efficient and effective. Participants in both the R61 (N=42) and R33 (N=82) will be youth between 12 and 17 years old currently experiencing a depressive disorder. Youth will be randomized to either an enhanced CBT intervention that teaches social cognitive skills, particularly social perspective taking and theory of mind as compared to CBT only. The primary target is improvement in the social cognitive skills at post treatment in the first trial (R61) and improvements in both social cognitive skills and depressive symptoms at post-treatment and at a 4-month follow-up (R33).
Detailed description
Depression in youth is a recurrent and impairing disorder. Although some treatments have shown modest effects in children and adolescents (e.g., cognitive behavioral therapy -- CBT), there remains a critical need to build upon these therapies in order to reach even more youths with depression. One variable hypothesized to affect children's interpersonal relationships is their level of social cognitive development on abilities particularly relevant to social functioning and CBT (e.g., social perspective taking; theory of mind). The first RCT (R61) will test the efficacy of an intervention aimed at increasing children's social cognitive (SC) abilities.Youth (ages 12-17; N=42) with depression diagnoses or clinical levels of depressive symptoms (CESD \> 20) will be randomized to either the social cognitive training enhanced CBT (SCT-CBT) or CBT only. Pre- and post-treatment evaluations will assess the social cognitions. In the second RCT (R33), we will conduct a replication trial with a new sample of 82 youth (ages 12-17) again randomized to SCT-CBT or CBT only. Youth will be evaluated with regard to the SC abilities (i.e., theory of mind), level of depressive symptoms, and social functioning at baseline, post-treatment, and at a 4-month follow-up (R33). Finally, in the R33 we will test if increases in SC abilities partially account for the relation between treatment condition and decreases in depression. If the SCT-CBT intervention significantly improves children's SC abilities and social functioning and decreases depression, then this will provide therapists with a more efficient and personalized treatment of depression in youth,
Interventions
BEHAVIORALCognitive behavior therapy with social cognitive training (CBT+SCT)
The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. We will conduct individual therapy based on the Coping with Stress manual used in other depression treatment studies with adolescents. In addition, the investigators will teach the teen explicitly about theory of mind and social perspective taking during each session and we will use examples from their own life to help them learn the skills.
BEHAVIORALCBT-only
The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. The investigators will conduct individual therapy based on the Coping with Stress manual used in other depression treatment studies with adolescents.
Sponsors
National Institute of Mental Health (NIMH)
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The individuals who conduct the assessments of the outcome measures will be unaware of to which condition the participant was randomized
Intervention model description
The study has two intervention arms: (1) CBT + SCT is cognitive behavioral therapy enhanced with training in social cognitive abilities (e.g., social perspective taking), and (2) CBT-only is cognitive behavioral therapy without the additional SCT training component. Adolescents are randomized to either condition. We will stratify randomization by gender, age (12-14; 15-17), race/ethnicity (minority status), and medication use.
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 12- to 17-years-old * diagnosis of a current depressive disorder (e.g., major depressive episode; persistent depressive disorder) or a score on the Children's Depression Rating Scale (CDRS) \>= 40
Exclusion criteria
* ever met criteria for a diagnosis of bipolar disorder, schizophrenia, autism, or conduct disorder * current alcohol or substance use disorder with significant impairment * imminent risk of suicide * reading level \< 4th grade * estimated IQ\<80
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Faux Pas Recognition Test | week 12 | The Faux Pas Recognition Task consists of 10 Faux Pas Stories and 10 Control Stories without a faux pas, scoring one point for every correct faux pas perception. The higher score is 20 and lower score 0; domain scores are scaled in a positive direction (i.e. higher scores denote higher theory of mind). Faux Pas Recognition test measures the ability to identify and explain faux pas situations where a character unintentionally insults another person due to lack of knowledge about some key feature of the other character. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Children Depression Rating Scale - Revised | week 12 | The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression). The CDRS-R is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113. Scores above 35 are considered to represent clinically significant symptoms. We measured depressive symptoms with the CDRS-R as a secondary outcome. |
Countries
United States
Participant flow
Recruitment details
Recruitment was primarily through a university listserv
Pre-assignment details
Participants were randomized to condition shortly after eligibility was confirmed.
Participants by arm
| Arm | Count |
|---|---|
| CBT+SCT Cognitive behavioral therapy plus social cognitive skills training (SCT)
Cognitive behavior therapy with social cognitive training (CBT+SCT): The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. We will conduct individual therapy based on the Coping with Stress manual used in other depression treatment studies with adolescents. In addition, the investigators will teach the teen explicitly about theory of mind and social perspective taking during each session and we will use examples from their own life to help them learn the skills. | 23 |
| CBT-only Cognitive behavioral therapy only (without SCT)
CBT-only: The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. The investigators will conduct individual therapy based on the Coping with Stress manual used in other depression treatment studies with adolescents. | 22 |
| Total | 45 |
Baseline characteristics
| Characteristic | CBT+SCT | CBT-only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 23 Participants | 22 Participants | 45 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.87 years STANDARD_DEVIATION 1.49 | 14.82 years STANDARD_DEVIATION 1.62 | 14.845 years STANDARD_DEVIATION 1.545 |
| Children's Depression Rating Scale | 48.26 units on a scale STANDARD_DEVIATION 5.66 | 48.77 units on a scale STANDARD_DEVIATION 6.32 | 48.52 units on a scale STANDARD_DEVIATION 5.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 20 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Faux Pas Recognition Test | 0.853 units on a scale STANDARD_DEVIATION 0.083 | 0.851 units on a scale STANDARD_DEVIATION 0.072 | 0.852 units on a scale STANDARD_DEVIATION 0.077 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 18 Participants | 37 Participants |
| Region of Enrollment United States | 23 participants | 22 participants | 45 participants |
| Sex: Female, Male Female | 15 Participants | 14 Participants | 29 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 22 |
| other Total, other adverse events | 0 / 23 | 0 / 22 |
| serious Total, serious adverse events | 0 / 23 | 0 / 22 |
Outcome results
Primary
Faux Pas Recognition Test
The Faux Pas Recognition Task consists of 10 Faux Pas Stories and 10 Control Stories without a faux pas, scoring one point for every correct faux pas perception. The higher score is 20 and lower score 0; domain scores are scaled in a positive direction (i.e. higher scores denote higher theory of mind). Faux Pas Recognition test measures the ability to identify and explain faux pas situations where a character unintentionally insults another person due to lack of knowledge about some key feature of the other character.
Time frame: week 12
Population: Participants were 45 youth (64% female), ages 12 through 17 years old (Mean = 14.84, S.D. = 1.54). Youth either met diagnostic criteria for a major depressive episode or persistent depressive disorder or a score of 35 or greater on the Children's Depression Rating Scale.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT+SCT | Faux Pas Recognition Test | 0.901 score on a scale | Standard Deviation 0.059 |
| CBT-only | Faux Pas Recognition Test | 0.854 score on a scale | Standard Deviation 0.071 |
Comparison: Statistical analysis will compare the post-intervention scores on the primary outcome (Faux Pas Recognition Test scores), controlling for pre-intervention scores.p-value: <0.05ANCOVA
Secondary
Children Depression Rating Scale - Revised
The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression). The CDRS-R is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113. Scores above 35 are considered to represent clinically significant symptoms. We measured depressive symptoms with the CDRS-R as a secondary outcome.
Time frame: week 12
Population: Study participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT+SCT | Children Depression Rating Scale - Revised | 23.74 score on a scale | Standard Deviation 5.59 |
| CBT-only | Children Depression Rating Scale - Revised | 34.59 score on a scale | Standard Deviation 10.6 |
p-value: <0.05ANCOVA