Effectiveness of Six Sessions CBT for Adolescents With Emotional Problems in Community Clinics

Depression Clinical Trial

— SMART  

Official title:

Effectiveness of Cognitive Behavioral Short-term Treatment for Adolescents With Emotional Symptom Problems in Community Clinics in Norway. A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150265
• Other study ID #: 2011/1937
• Secondary ID: 8563/PFP1112-13
• Status: Completed
• Phase: N/A
• Start date: January 1, 2013
• Est. completion date: March 1, 2018

Study information

• Verified date: May 2019
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: March 1, 2018
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Agoraphobia
• Anxiety Disorders
• Depression
• Disease
• Generalized Anxiety Disorder
• Panic Disorder
• Phobia, Social
• Social Phobia

Intervention

Behavioral:
• SMART manual cognitive behavioral therapy

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø

Sponsors (3)

Lead Sponsor	Collaborator
University of Tromso	Regionsenter for barn og unges psykiske helse, The Royal Norwegian Ministry of Health

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Status of primary emotional disorder based on theDevelopment and Well-Being Assessment (DAWBA) interview schedule with parents and youths	Diagnostic interview	At recruitment, before treatment start and at 6 months follow up
Secondary	SDQ Strengths and Difficulties Questionnaire	Measure of general emotional and behavioral symptoms and strengths	At recruitment, before treatment start and at 6 months follow up
Secondary	Anxiety symptom score on the Multi-Dimensional Anxiety Scale for Children (MASC)	Measure of anxiety symptoms	At recruitment, before treatment start and at 6 months follow up
Secondary	Depression symptom status as measured by the self-rating instrument Beck Depression Inventory (BDI-II)	Measure of depressive symptoms	At recruitment, before treatment start and at 6 months follow up
Secondary	Life functioning as measured by the rating scale C-GAS rated by clinicians	Measure of functioning	At recruitment, before treatment start and at 6 months follow up
Secondary	General outcome measured by Clinical Outcomes in Routine Evaluations Outcome Measure (CORE-OM)	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