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Completed

NCT Number: NCT02150265

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

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.

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Key information

Conditions

Generalized Anxiety Disorder Agoraphobia Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Panic Disorder Phobia, Social Phobic Disorders Social Phobia

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of North Norway

Tromsø, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMART manual cognitive behavioral therapy

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Tromso

Other

Collaborators

  • Regionsenter for barn og unges psykiske helse
  • The Royal Norwegian Ministry of Health

Registry information

Official study title

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

Acronym: SMART

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
May 29, 2014
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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