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CompletedNCT02150265SMARTUpdated May 23, 2019

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

An interventional study of SMART manual cognitive behavioral therapy in Generalized Anxiety Disorder, Social Phobia and Agoraphobia, sponsored by University of Tromso. Completed at 1 site in Norway. Open to participants aged 14 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-05-23.

Sponsored by University of Tromso · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jan 2013, registered May 2014).
Phase
Not applicable
Study type
Interventional
Enrollment
163
Allocation
Randomized
Ages
14 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Generalized Anxiety Disorder
  • Social Phobia
  • Agoraphobia
  • Depression
  • Panic Disorder
03

In context

Generalized Anxiety Disorder

517 studies on the registry are indexed under Generalized Anxiety Disorder; 124 are open to participants now.

This study's enrollment of 163 is above the median of 83 across 439 interventional studies indexed under Generalized Anxiety Disorder.

Browse Generalized Anxiety Disorder studies →

Lead sponsor

University of Tromso is the lead sponsor of 60 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
163 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralSMART manual cognitive behavioral therapy
06

What researchers measure

Primary outcomes

  1. Status of primary emotional disorder based on theDevelopment and Well-Being Assessment (DAWBA) interview schedule with parents and youths

    Diagnostic interview

    Time frame: At recruitment, before treatment start and at 6 months follow up

Secondary outcomes

  1. SDQ Strengths and Difficulties Questionnaire

    Measure of general emotional and behavioral symptoms and strengths

    Time frame: At recruitment, before treatment start and at 6 months follow up

  2. Anxiety symptom score on the Multi-Dimensional Anxiety Scale for Children (MASC)

    Measure of anxiety symptoms

    Time frame: At recruitment, before treatment start and at 6 months follow up

  3. Depression symptom status as measured by the self-rating instrument Beck Depression Inventory (BDI-II)

    Measure of depressive symptoms

    Time frame: At recruitment, before treatment start and at 6 months follow up

  4. Life functioning as measured by the rating scale C-GAS rated by clinicians

    Measure of functioning

    Time frame: At recruitment, before treatment start and at 6 months follow up

  5. General outcome measured by Clinical Outcomes in Routine Evaluations Outcome Measure (CORE-OM)

    Measure of symptoms, risk, functioning and total burden of disorder

    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

07

Study locations

1 site
  • University Hospital of North Norway
    Tromsø, Norway
08

References and documents

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. PubMed 35791020 ↗
  • 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. PubMed 32171328 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02150265
Lead sponsor
University of Tromso
Collaborators
The Royal Norwegian Ministry of Health, Regionsenter for barn og unges psykiske helse
Responsible party
Sponsor
First posted
May 29, 2014
Start date
Jan 1, 2013
Primary completion
Jun 30, 2017
Completion
Mar 1, 2018
Last update
May 23, 2019

Study contacts

Ingunn Skre, PhD
principal investigator · UiT Arctic University of Norway
Simon-Peter Neumer, Dr philos
study chair · Regionsenter for barn og unges psykiske helse, Sør-Øst

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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