Clinical trial NCT02150265: Effectiveness of Six Sessions CBT for Adolescents With Emotional Problems in Community Clinics
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
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Social Phobia
Agoraphobia
Depression
Panic Disorder
Lead sponsor: University of Tromso
Sponsor class: OTHER
Collaborators: name: The Royal Norwegian Ministry of Health
name: Regionsenter for barn og unges psykiske helse
First posted: 2014-05-29
Enrollment: 163
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Status of primary emotional disorder based on theDevelopment and Well-Being Assessment (DAWBA) interview schedule with parents and youths
timeFrame: At recruitment, before treatment start and at 6 months follow up
Secondary outcomes:
measure: SDQ Strengths and Difficulties Questionnaire
timeFrame: At recruitment, before treatment start and at 6 months follow up
measure: Anxiety symptom score on the Multi-Dimensional Anxiety Scale for Children (MASC)
timeFrame: At recruitment, before treatment start and at 6 months follow up
measure: Depression symptom status as measured by the self-rating instrument Beck Depression Inventory (BDI-II)
timeFrame: At recruitment, before treatment start and at 6 months follow up
measure: Life functioning as measured by the rating scale C-GAS rated by clinicians
timeFrame: At recruitment, before treatment start and at 6 months follow up
measure: General outcome measured by Clinical Outcomes in Routine Evaluations Outcome Measure (CORE-OM)
timeFrame: At recruitment, before treatment start and at 6 months follow up. The short version (CORE 10) mid-therapy: 3 weeks after starting treatment
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: UiT Arctic University of Norway
name: Ingunn Skre, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regionsenter for barn og unges psykiske helse, Sør-Øst
name: Simon-Peter Neumer, Dr philos
role: STUDY_CHAIR
References:
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.
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.