- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02150265
Effectiveness of Six Sessions CBT for Adolescents With Emotional Problems in Community Clinics (SMART)
Effectiveness of Cognitive Behavioral Short-term Treatment for Adolescents With Emotional Symptom Problems in Community Clinics in Norway. A Randomized Controlled Study
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tromsø, Norway
- University Hospital of North Norway
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Age 14 to 18 years Referred to Community Mental Health Clinic for Children and Adolescents
- Score above 6 on Emotional symptoms scale on the SDQ Fluent Norwegian language
Exclusion Criteria:
- Indicators for Pervasive Developmental Disorder (PDD) Acute suicidal symptoms Psycho-active drug treatment start coinciding with start of intervention Symptoms indicating psychotic disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At recruitment, before treatment start and at 6 months follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At recruitment, before treatment start and at 6 months follow up
|
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
|
At recruitment, before treatment start and at 6 months follow up
|
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
|
At recruitment, before treatment start and at 6 months follow up
|
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
|
At recruitment, before treatment start and at 6 months follow up
|
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
|
At recruitment, before treatment start and at 6 months follow up. The short version (CORE 10) mid-therapy: 3 weeks after starting treatment
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Publications and helpful links
General Publications
- Lorentzen V, Fagermo K, Handegard BH, Neumer SP, Skre I. Long-term effectiveness and trajectories of change after treatment with SMART, a transdiagnostic CBT for adolescents with emotional problems. BMC Psychol. 2022 Jul 5;10(1):167. doi: 10.1186/s40359-022-00872-y.
- Lorentzen V, Fagermo K, Handegard BH, Skre I, Neumer SP. A randomized controlled trial of a six-session cognitive behavioral treatment of emotional disorders in adolescents 14-17 years old in child and adolescent mental health services (CAMHS). BMC Psychol. 2020 Mar 14;8(1):25. doi: 10.1186/s40359-020-0393-x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011/1937
- 8563/PFP1112-13 (Other Grant/Funding Number: Northern Norway Regional Health Authority (Helse Nord RHF))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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