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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
Sponsor:
Collaborators:
The Royal Norwegian Ministry of Health
Regionsenter for barn og unges psykiske helse
Information provided by (Responsible Party):
University of Tromso

Brief 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.


Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Social Phobia Agoraphobia Depression Panic Disorder Behavioral: SMART manual cognitive behavioral therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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
Behavioral: SMART manual cognitive behavioral therapy



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Norway
University Hospital of North Norway
Tromsø, Norway
Sponsors and Collaborators
University of Tromso
The Royal Norwegian Ministry of Health
Regionsenter for barn og unges psykiske helse
Investigators
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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

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Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT02150265     History of Changes
Other Study ID Numbers: 2011/1937
8563/PFP1112-13 ( Other Grant/Funding Number: Northern Norway Regional Health Authority (Helse Nord RHF) )
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Panic Disorder
Phobia, Social
Agoraphobia
Pathologic Processes
Mental Disorders
Phobic Disorders