Generalized Anxiety DisorderSMARTNCT02150265
Effectiveness of Six Sessions CBT for Adolescents With Emotional Problems in Community Clinics
A study testing SMART manual cognitive behavioral therapy in people with Generalized Anxiety Disorder and Social Phobia, run by University of Tromso at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Generalized Anxiety Disorder, Social Phobia, Agoraphobia
- What is being tested?
- SMART manual cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2013to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Indicators for Pervasive Developmental Disorder (PDD) Acute suicidal symptoms Psycho-active drug treatment start coinciding with start of intervention Symptoms indicating psychotic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Cognitive Behavioral Short-term Treatment for Adolescents With Emotional Symptom Problems in Community Clinics in Norway. A Randomized Controlled Study
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.
Read more
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.
- Being tested
- SMART manual cognitive behavioral therapy
- Medical subject headings
- Generalized Anxiety Disorder, Phobia, Social, Agoraphobia, Depression, Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART manual cognitive behavioral therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Waiting list control group | No intervention | 6 week waiting list |
| Individual cognitive behavioral therapy with SMART | Experimental | SMART manual cognitive behavioral therapy individual weekly sessions for 6 weeks Receives: Behavioral: SMART manual cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Status of primary emotional disorder based on theDevelopment and Well-Being Assessment (DAWBA) interview schedule with parents and youths
Diagnostic interview
Measured: At recruitment, before treatment start and at 6 months follow up
Secondary outcomes (5)
SDQ Strengths and Difficulties Questionnaire
Measure of general emotional and behavioral symptoms and strengths
Measured: At recruitment, before treatment start and at 6 months follow up
Anxiety symptom score on the Multi-Dimensional Anxiety Scale for Children (MASC)
Measure of anxiety symptoms
Measured: At recruitment, before treatment start and at 6 months follow up
Depression symptom status as measured by the self-rating instrument Beck Depression Inventory (BDI-II)
Measure of depressive symptoms
Measured: At recruitment, before treatment start and at 6 months follow up
Life functioning as measured by the rating scale C-GAS rated by clinicians
Measure of functioning
Measured: At recruitment, before treatment start and at 6 months follow up
General outcome measured by Clinical Outcomes in Routine Evaluations Outcome Measure (CORE-OM)
Measure of symptoms, risk, functioning and total burden of disorder
Measured: At recruitment, before treatment start and at 6 months follow up. The short version (CORE 10) mid-therapy: 3 weeks after starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study start1 Jan 2013
- Primary completion30 Jun 2017
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health, Regionsenter for barn og unges psykiske helse
- Responsible party
- Sponsor
- Investigators
- Ingunn Skre, PhD, Principal investigator, UiT Arctic University of NorwaySimon-Peter Neumer, Dr philos, Study chair, Regionsenter for barn og unges psykiske helse, Sør-Øst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150265
- Sponsor's protocol ID
- 2011/1937
- Other IDs
- 8563/PFP1112-13
- Acronym
- SMART
- Status last verified
- May 2019
- First submitted
- 26 May 2014
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
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 35791020Lorentzen 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
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cognitive Behavioral Short-term Treatment for Adolescents With Emotional Symptom Problems in Community Clinics in Norway. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02150265
- Acronym / sponsor ID
- SMART / 2011/1937
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health, Regionsenter for barn og unges psykiske helse
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waiting list control group | No intervention | –6 week waiting list |
| Individual cognitive behavioral therapy with SMART | Experimental | Behavioral: SMART manual cognitive behavioral therapySMART manual cognitive behavioral therapy individual weekly sessions for 6 weeks |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Indicators for Pervasive Developmental Disorder (PDD) Acute suicidal symptoms Psycho-active drug treatment start coinciding with start of intervention Symptoms indicating psychotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMART manual cognitive behavioral therapy | Behavioural | Individual cognitive behavioral therapy with SMART |
Primary outcome
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
5 secondary outcomes
SDQ Strengths and Difficulties Questionnaire
Time frame: At recruitment, before treatment start and at 6 months follow up
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Derived from this study: PubMed 35791020Lorentzen 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.
- Derived from this study: PubMed 32171328Lorentzen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART manual cognitive behavioral therapy in people with Generalized Anxiety Disorder and Social Phobia, run by University of Tromso at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02150265, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.