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

Primary Purpose

Generalized Anxiety Disorder, Social Phobia, Agoraphobia

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
SMART manual cognitive behavioral therapy
Sponsored by
University of Tromso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of North Norway

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Waiting list control group

Individual cognitive behavioral therapy with SMART

Arm Description

6 week waiting list

SMART manual cognitive behavioral therapy individual weekly sessions for 6 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

SDQ Strengths and Difficulties Questionnaire
Measure of general emotional and behavioral symptoms and strengths
Anxiety symptom score on the Multi-Dimensional Anxiety Scale for Children (MASC)
Measure of anxiety symptoms
Depression symptom status as measured by the self-rating instrument Beck Depression Inventory (BDI-II)
Measure of depressive symptoms
Life functioning as measured by the rating scale C-GAS rated by clinicians
Measure of functioning
General outcome measured by Clinical Outcomes in Routine Evaluations Outcome Measure (CORE-OM)
Measure of symptoms, risk, functioning and total burden of disorder

Full Information

First Posted
May 26, 2014
Last Updated
May 21, 2019
Sponsor
University of Tromso
Collaborators
The Royal Norwegian Ministry of Health, Regionsenter for barn og unges psykiske helse
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1. Study Identification

Unique Protocol Identification Number
NCT02150265
Brief Title
Effectiveness of Six Sessions CBT for Adolescents With Emotional Problems in Community Clinics
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tromso
Collaborators
The Royal Norwegian Ministry of Health, Regionsenter for barn og unges psykiske helse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Social Phobia, Agoraphobia, Depression, Panic Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waiting list control group
Arm Type
No Intervention
Arm Description
6 week waiting list
Arm Title
Individual cognitive behavioral therapy with SMART
Arm Type
Experimental
Arm Description
SMART manual cognitive behavioral therapy individual weekly sessions for 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
SMART manual cognitive behavioral therapy
Primary Outcome Measure Information:
Title
Status of primary emotional disorder based on theDevelopment and Well-Being Assessment (DAWBA) interview schedule with parents and youths
Description
Diagnostic interview
Time Frame
At recruitment, before treatment start and at 6 months follow up
Secondary Outcome Measure Information:
Title
SDQ Strengths and Difficulties Questionnaire
Description
Measure of general emotional and behavioral symptoms and strengths
Time Frame
At recruitment, before treatment start and at 6 months follow up
Title
Anxiety symptom score on the Multi-Dimensional Anxiety Scale for Children (MASC)
Description
Measure of anxiety symptoms
Time Frame
At recruitment, before treatment start and at 6 months follow up
Title
Depression symptom status as measured by the self-rating instrument Beck Depression Inventory (BDI-II)
Description
Measure of depressive symptoms
Time Frame
At recruitment, before treatment start and at 6 months follow up
Title
Life functioning as measured by the rating scale C-GAS rated by clinicians
Description
Measure of functioning
Time Frame
At recruitment, before treatment start and at 6 months follow up
Title
General outcome measured by Clinical Outcomes in Routine Evaluations Outcome Measure (CORE-OM)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingunn Skre, PhD
Organizational Affiliation
UiT Arctic University of Norway
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simon-Peter Neumer, Dr philos
Organizational Affiliation
Regionsenter for barn og unges psykiske helse, Sør-Øst
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of North Norway
City
Tromsø
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
35791020
Citation
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.
Results Reference
derived
PubMed Identifier
32171328
Citation
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.
Results Reference
derived

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

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