Effectiveness of Six Sessions CBT for Adolescents With Emotional Problems in Community Clinics (SMART)
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|ClinicalTrials.gov Identifier: NCT02150265|
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : May 23, 2019
Background: There is need for more effectiveness studies concerning treatment of emotional symptom problems indicating anxiety and depression in adolescents. SMART is the only treatment manual for combined emotional disorders developed in Norwegian.
Purpose: To find the best individualized treatment for adolescents with emotional difficulties by: Finding criteria for the selection of appropriate patients for treatment with cognitive-behavior therapy program SMART in an outpatient population (14-18 years). Finding predictors of completion of treatment program SMART. Examining the effects of treatment with the SMART program at 6 months follow-up.
Design: A randomized controlled study in six outpatient clinics in the north of Norway. N= 160 referred adolescents (14-18 years) with score above 6 on the Emotional Problems scale of the Strength and Difficulties Questionnaire (SDQ). Two thirds are treated according to the SMART-manual immediately, while the waiting list control group is treated with SMART after six weeks.
Hypothesis: The SMART treatment is an effective treatment for emotional symptom problems.
Publication: The results sought published internationally and nationally and will be communicated to clinicians.
|Condition or disease||Intervention/treatment||Phase|
|Generalized Anxiety Disorder Social Phobia Agoraphobia Depression Panic Disorder||Behavioral: SMART manual cognitive behavioral therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||163 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effectiveness of Cognitive Behavioral Short-term Treatment for Adolescents With Emotional Symptom Problems in Community Clinics in Norway. A Randomized Controlled Study|
|Actual Study Start Date :||January 1, 2013|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||March 1, 2018|
No Intervention: Waiting list control group
6 week waiting list
Experimental: Individual cognitive behavioral therapy with SMART
SMART manual cognitive behavioral therapy individual weekly sessions for 6 weeks
Behavioral: SMART manual cognitive behavioral therapy
- Status of primary emotional disorder based on theDevelopment and Well-Being Assessment (DAWBA) interview schedule with parents and youths [ Time Frame: At recruitment, before treatment start and at 6 months follow up ]Diagnostic interview
- SDQ Strengths and Difficulties Questionnaire [ Time Frame: At recruitment, before treatment start and at 6 months follow up ]Measure of general emotional and behavioral symptoms and strengths
- Anxiety symptom score on the Multi-Dimensional Anxiety Scale for Children (MASC) [ Time Frame: At recruitment, before treatment start and at 6 months follow up ]Measure of anxiety symptoms
- Depression symptom status as measured by the self-rating instrument Beck Depression Inventory (BDI-II) [ Time Frame: At recruitment, before treatment start and at 6 months follow up ]Measure of depressive symptoms
- Life functioning as measured by the rating scale C-GAS rated by clinicians [ Time Frame: At recruitment, before treatment start and at 6 months follow up ]Measure of functioning
- General outcome measured by Clinical Outcomes in Routine Evaluations Outcome Measure (CORE-OM) [ Time Frame: At recruitment, before treatment start and at 6 months follow up. The short version (CORE 10) mid-therapy: 3 weeks after starting treatment ]Measure of symptoms, risk, functioning and total burden of disorder
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): NCT02150265
|University Hospital of North Norway|
|Principal Investigator:||Ingunn Skre, PhD||UiT Arctic University of Norway|
|Study Chair:||Simon-Peter Neumer, Dr philos||Regionsenter for barn og unges psykiske helse, Sør-Øst|