Obsessive-Compulsive Disorder in ChildrenTECTONCT03595098
Treatment Effects of Family Based Cognitive Therapy in Children and Adolescents With Obsessive Compulsive Disorder
A study testing Family Based Cognitive Behavioural Therapy and Family Based Psychoeducation/Relaxation Training in people with Obsessive-Compulsive Disorder in Children and Obsessive-Compulsive Disorder in Adolescence, run by Anne Katrine Pagsberg at 1 site in Denmark.
Trial summary
To investigate the benefits and harms, and the neural and neurocognitive mediators of treatment response, in family-based cognitive behavioural therapy versus family-based psychoeducation and relaxation training in children and adolescents with obsessive compulsive disorder. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Obsessive-Compulsive Disorder in Children, Obsessive-Compulsive Disorder in Adolescence
- What is being tested?
- Family Based Cognitive Behavioural Therapy and Family Based Psychoeducation/Relaxation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Aug 2018to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- OCD diagnosis as primary diagnosis, meeting the criteria for International Classification of Diseases 10 (ICD-10) F42, verified with a semi-structured psychopathological interview using Schedule for Affective Disorders and Schizophrenia for school-aged children, Present and Lifetime version (K-SADS-PL).
- Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) entry score ≥16, a cut-off score used in previous studies.
- Age 8 through 17 years (both inclusive).
- Signed informed consent.
Who cannot join
- Comorbid illness that contraindicates trial participation: pervasive developmental disorder not including Asperger's syndrome (ICD-10 F84.0-84.4 + F84.8-84.9), schizophrenia/paranoid psychosis (ICD-10 F20-25 + F28-29), mania or bipolar disorder (ICD-10 F30 and F31), depressive psychotic disorders (F32.3 + F33.3), substance dependence syndrome (ICD-10 F1x.2).
- Intelligence Quotient <70.
- Treatment with Cognitive Behavioural Therapy (CBT), Serotonin Reuptake Inhibitors, or other antidepressant medication or antipsychotic medication within the last 6 months prior to trial entry.
- For MRI-scanning:
- metal braces on teeth or metal implants;
- any known brain pathology;
- history of severe head-trauma (ICD-10 S6-S9);
- pregnancy.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Child and Adolescent Mental Health Centre, Bispebjerg
Copenhagen, 2100
About this study
To investigate the benefits and harms, and the neural and neurocognitive mediators of treatment response, in family-based cognitive behavioural therapy versus family-based psychoeducation and relaxation training in children and adolescents with obsessive compulsive disorder. The aim is to conduct this investigation in an optimal trial design with the lowest possible risk of bias.
Read the detailed description
Obsessive-compulsive disorder is the fourth most common psychiatric disorder, affecting 1-3% of children and adolescents globally. The recommended first-line treatment is cognitive behavioral therapy with exposure and response prevention. Yet, more than 40% of patients do not, or only partially, benefit from therapy. A better understanding of the mechanisms underlying response to cognitive behavioral therapy is needed to improve treatment. In the TECTO study, we will conduct a combined randomized clinical trial and longitudinal case-control study to elucidate how neural, cognitive, emotional, and neuroendocrine factors moderate and mediate treatment response. At baseline, 128 children and adolescents with obsessive-compulsive disorder will be compared to 128 healthy control participants to map neurobiological, cognitive, and emotional markers of obsessive-compulsive disorder. After baseline assessment, patients are randomly assigned to 16 weeks of either cognitive behavioral therapy with exposure and response prevention or an active control treatment with psychoeducation and relaxation training. This design allows us to test how factors that are specific to cognitive behavioral therapy (e.g. exposure and response prevention) contribute to observed treatment effects. Our primary outcome is OCD symptom severity measured with the Children's Yale-Brown Obessive-Compulsive Scale. Secondary outcomes are health-related quality of life and negative treatment effects. To detect neural and cognitive mediators of treatment, we will measure brain structure and function, and cognitive performance, at baseline and end-of-treatment. Furthermore, we will monitor a range of therapeutic, emotional, family, and neuroendocrine factors before, during, and after treatment. We expect that findings from TECTO will have important theoretical implications and will help refine our understanding of OCD as a heterogeneous and multidimensional disorder. Finally, we expect that our findings will contribute significantly to the improvement of psychotherapy and development of more targeted interventions for pediatric obsessive-compulsive disorder, which can minimize the use of medication, prevent chronicity, and reduce the substantial socioeconomic burden of the disorder.
- Being tested
- Family Based Cognitive Behavioural Therapy, Family Based Psychoeducation/Relaxation Training
- Keywords
- OCD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Based Cognitive Behavioural TherapyBehavioural
Family Based Cognitive Behavioural Therapy (FCBT) focuses on the interrelation between thought, emotion, and behaviour, Exposure and Response Prevention, family involvement, homework assignments, and formulating of specific goals for the child. The important, active components is Exposure and Response Prevention. It involves exposing the child to a feared object, situation or thought, and preventing the child from carrying out compulsions to show the child that distress/anxiety can decrease or disappear without performing rituals.
Family Based Psychoeducation/Relaxation TrainingBehavioural
Family-based Psychoeducation/Relaxation Training (FPRT) as an active control matches the experimental intervention as closely as possible, many elements of the control intervention are similar to FCBT. The main and intended difference between the two approaches is the absence of the Exposure and Response Prevention component, which is deemed the most effective treatment for OCD.
| Study group | Role | What they receive |
|---|---|---|
| FCBT | Experimental | The Family Based Cognitive Behavioural Therapy (FCBT) Receives: Behavioral: Family Based Cognitive Behavioural Therapy |
| FPRT | Active comparator | Family-based Psychoeducation /Relaxation Training (FPRT) Receives: Behavioral: Family Based Psychoeducation/Relaxation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score
Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) is a 10-item questionnaire assessing the severity of obsessive compulsive disorder (OCD). Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.
Measured: Week 0, 4, 8, 16 and 40
Secondary outcomes (2)
health-related quality of life assesses with KIDSCREEN-52
The KIDSCREEN instruments assess children's and adolescents' subjective health and well-being- health-related quality of life (HRQoL). Questionnaire consisted of 52 items which assessed HRQoL in 10 dimensions: physical well-being, psychological well-being, moods and emotions, self perception, autonomy, relation with parents and home life, social support and peers, school environment, social acceptance, and financial resources. Rasch scores are computed for each dimension and are transformed into T-values with a mean of 50 and a standard deviation of 10; higher scores indicate better HRQoL and well-being.
Measured: Week 0, 4, 8, 16 and 40
Occurrence of negative adverse events
The occurrence of negative adverse events is assessed with the Negative Effects Questionnaire (NEQ). The questionnaire is used for both parental reports and self-reports. It consists of 32 items that are scored on a five-point Likert-scale (0-4) where the highest value represents a severe negative effect of the event. The questionnaire differentiates between negative effects that are attributed to the treatment and those possibly caused by other circumstances, as well as one open-ended question.
Measured: Week 4, 8, 16 and 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start28 Aug 2018
- Primary completion7 Apr 2022
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive Disorder in ChildrenStudies 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
- Model description
- single-centre, parallel group superiority randomised clinical trial with blinded outcome assessment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anne Katrine Pagsberg
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Research Centre for Magnetic Resonance, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Responsible party
- Sponsor-investigator, Anne Katrine Pagsberg, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Investigators
- Anne Katrine Pagsberg, Professor, Principal investigator, Child and Adolescent Mental Health Centre, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595098
- Sponsor's protocol ID
- TECTO
- Acronym
- TECTO
- Status last verified
- Jul 2024
- First submitted
- 3 May 2018
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pretzmann L, Christensen SH, Bryde Christensen A, Funch Uhre C, Uhre V, Thoustrup CL, Clemmesen IT, Gudmandsen TA, Korsbjerg NLJ, Mora-Jensen AC, Ritter M, Olsen MH, Clemmensen LKH, Lindschou J, Gluud C, Thomsen PH, Vangkilde S, Hagstrom J, Rozental A, Jeppesen P, Verhulst F, Hybel KA, Lonfeldt NN, Plessen KJ, Poulsen S, Pagsberg AK. Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder: A mixed methods study and analysis plan for the TECTO trial. Contemp Clin Trials Commun. 2023 Jun 20;34:101173. doi: 10.1016/j.conctc.2023.101173. eCollection 2023 Aug.
PubMed 37497354Olsen MH, Hagstrom J, Lonfeldt NN, Uhre C, Uhre V, Pretzmann L, Christensen SH, Thoustrup C, Korsbjerg NLJ, Mora-Jensen AC, Ritter M, Engstrom J, Lindschou J, Siebner HR, Verhulst F, Jeppesen P, Jepsen JRM, Vangkilde S, Thomsen PH, Hybel K, Clemmesen LKH, Gluud C, Plessen KJ, Pagsberg AK, Jakobsen JC. Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents (the TECTO trial): a statistical analysis plan for the randomised clinical trial. Trials. 2022 Oct 6;23(1):854. doi: 10.1186/s13063-022-06799-4.
PubMed 36203215Pagsberg AK, Uhre C, Uhre V, Pretzmann L, Christensen SH, Thoustrup C, Clemmesen I, Gudmandsen AA, Korsbjerg NLJ, Mora-Jensen AC, Ritter M, Thorsen ED, Halberg KSV, Bugge B, Staal N, Ingstrup HK, Moltke BB, Kloster AM, Zoega PJ, Mikkelsen MS, Harboe GS, Larsen KF, Clemmensen LKH, Lindschou J, Jakobsen JC, Engstrom J, Gluud C, Siebner HR, Thomsen PH, Hybel K, Verhulst F, Jeppesen P, Jepsen JRM, Vangkilde S, Olsen MH, Hagstrom J, Lonfeldt NN, Plessen KJ. Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents: protocol for a randomised clinical trial (the TECTO trial). BMC Psychiatry. 2022 Mar 19;22(1):204. doi: 10.1186/s12888-021-03669-2.
PubMed 35305587
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Effects of Family Based Cognitive Therapy in Children and Adolescents With Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT03595098
- Acronym / sponsor ID
- TECTO / TECTO
- Keywords
- OCD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Anne Katrine PagsbergUniversity, hospital or other
- Collaborators
- Danish Research Centre for Magnetic Resonance, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jul 2018 (actual)
- 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.
To investigate the benefits and harms, and the neural and neurocognitive mediators of treatment response, in family-based cognitive behavioural therapy versus family-based psychoeducation and relaxation training in children and adolescents with obsessive compulsive disorder. The aim is to conduct this investigation in an optimal trial design with the lowest possible risk of bias.
Detailed description
Obsessive-compulsive disorder is the fourth most common psychiatric disorder, affecting 1-3% of children and adolescents globally. The recommended first-line treatment is cognitive behavioral therapy with exposure and response prevention. Yet, more than 40% of patients do not, or only partially, benefit from therapy. A better understanding of the mechanisms underlying response to cognitive behavioral therapy is needed to improve treatment. In the TECTO study, we will conduct a combined randomized clinical trial and longitudinal case-control study to elucidate how neural, cognitive, emotional, and neuroendocrine factors moderate and mediate treatment response. At baseline, 128 children and adolescents with obsessive-compulsive disorder will be compared to 128 healthy control participants to map neurobiological, cognitive, and emotional markers of obsessive-compulsive disorder. After baseline assessment, patients are randomly assigned to 16 weeks of either cognitive behavioral therapy with exposure and response prevention or an active control treatment with psychoeducation and relaxation training. This design allows us to test how factors that are specific to cognitive behavioral therapy (e.g. exposure and response prevention) contribute to observed treatment effects. Our primary outcome is OCD symptom severity measured with the Children's Yale-Brown Obessive-Compulsive Scale. Secondary outcomes are health-related quality of life and negative treatment effects. To detect neural and cognitive mediators of treatment, we will measure brain structure and function, and cognitive performance, at baseline and end-of-treatment. Furthermore, we will monitor a range of therapeutic, emotional, family, and neuroendocrine factors before, during, and after treatment. We expect that findings from TECTO will have important theoretical implications and will help refine our understanding of OCD as a heterogeneous and multidimensional disorder. Finally, we expect that our findings will contribute significantly to the improvement of psychotherapy and development of more targeted interventions for pediatric obsessive-compulsive disorder, which can minimize the use of medication, prevent chronicity, and reduce the substantial socioeconomic burden of the disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- single-centre, parallel group superiority randomised clinical trial with blinded outcome assessment
| Arm | Type | Receives |
|---|---|---|
| FCBT | Experimental | Behavioral: Family Based Cognitive Behavioural TherapyThe Family Based Cognitive Behavioural Therapy (FCBT) |
| FPRT | Active comparator | Behavioral: Family Based Psychoeducation/Relaxation TrainingFamily-based Psychoeducation /Relaxation Training (FPRT) |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- OCD diagnosis as primary diagnosis, meeting the criteria for International Classification of Diseases 10 (ICD-10) F42, verified with a semi-structured psychopathological interview using Schedule for Affective Disorders and Schizophrenia for school-aged children, Present and Lifetime version (K-SADS-PL).
- Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) entry score ≥16, a cut-off score used in previous studies.
- Age 8 through 17 years (both inclusive).
- Signed informed consent.
Key exclusion criteria (8 listed)
- Comorbid illness that contraindicates trial participation: pervasive developmental disorder not including Asperger's syndrome (ICD-10 F84.0-84.4 + F84.8-84.9), schizophrenia/paranoid psychosis (ICD-10 F20-25 + F28-29), mania or bipolar disorder (ICD-10 F30 and F31), depressive psychotic disorders (F32.3 + F33.3), substance dependence syndrome (ICD-10 F1x.2).
- Intelligence Quotient <70.
- Treatment with Cognitive Behavioural Therapy (CBT), Serotonin Reuptake Inhibitors, or other antidepressant medication or antipsychotic medication within the last 6 months prior to trial entry.
- For MRI-scanning:
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 |
|---|---|---|
| Family Based Cognitive Behavioural TherapyFamily Based Cognitive Behavioural Therapy (FCBT) focuses on the interrelation between thought, emotion, and behaviour, Exposure and Response Prevention, family involvement, homework assignments, and formulating of specific goals for the child. The important, active components is Exposure and Response Prevention. It involves exposing the child to a feared object, situation or thought, and preventing the child from carrying out compulsions to show the child that distress/anxiety can decrease or disappear without performing rituals. | Behavioural | FCBT |
| Family Based Psychoeducation/Relaxation TrainingFamily-based Psychoeducation/Relaxation Training (FPRT) as an active control matches the experimental intervention as closely as possible, many elements of the control intervention are similar to FCBT. The main and intended difference between the two approaches is the absence of the Exposure and Response Prevention component, which is deemed the most effective treatment for OCD. | Behavioural | FPRT |
Primary outcome
Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score
Time frame: Week 0, 4, 8, 16 and 40
Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) is a 10-item questionnaire assessing the severity of obsessive compulsive disorder (OCD). Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.
2 secondary outcomes
health-related quality of life assesses with KIDSCREEN-52
Time frame: Week 0, 4, 8, 16 and 40
Occurrence of negative adverse events
Time frame: Week 4, 8, 16 and 40
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Derived from this study: PubMed 37497354Pretzmann L, Christensen SH, Bryde Christensen A, Funch Uhre C, Uhre V, Thoustrup CL, Clemmesen IT, Gudmandsen TA, Korsbjerg NLJ, Mora-Jensen AC, Ritter M, Olsen MH, Clemmensen LKH, Lindschou J, Gluud C, Thomsen PH, Vangkilde S, Hagstrom J, Rozental A, Jeppesen P, Verhulst F, Hybel KA, Lonfeldt NN, Plessen KJ, Poulsen S, Pagsberg AK. Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder: A mixed methods study and analysis plan for the TECTO trial. Contemp Clin Trials Commun. 2023 Jun 20;34:101173. doi: 10.1016/j.conctc.2023.101173. eCollection 2023 Aug.
- Derived from this study: PubMed 36203215Olsen MH, Hagstrom J, Lonfeldt NN, Uhre C, Uhre V, Pretzmann L, Christensen SH, Thoustrup C, Korsbjerg NLJ, Mora-Jensen AC, Ritter M, Engstrom J, Lindschou J, Siebner HR, Verhulst F, Jeppesen P, Jepsen JRM, Vangkilde S, Thomsen PH, Hybel K, Clemmesen LKH, Gluud C, Plessen KJ, Pagsberg AK, Jakobsen JC. Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents (the TECTO trial): a statistical analysis plan for the randomised clinical trial. Trials. 2022 Oct 6;23(1):854. doi: 10.1186/s13063-022-06799-4.
- Derived from this study: PubMed 35305587Pagsberg AK, Uhre C, Uhre V, Pretzmann L, Christensen SH, Thoustrup C, Clemmesen I, Gudmandsen AA, Korsbjerg NLJ, Mora-Jensen AC, Ritter M, Thorsen ED, Halberg KSV, Bugge B, Staal N, Ingstrup HK, Moltke BB, Kloster AM, Zoega PJ, Mikkelsen MS, Harboe GS, Larsen KF, Clemmensen LKH, Lindschou J, Jakobsen JC, Engstrom J, Gluud C, Siebner HR, Thomsen PH, Hybel K, Verhulst F, Jeppesen P, Jepsen JRM, Vangkilde S, Olsen MH, Hagstrom J, Lonfeldt NN, Plessen KJ. Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents: protocol for a randomised clinical trial (the TECTO trial). BMC Psychiatry. 2022 Mar 19;22(1):204. doi: 10.1186/s12888-021-03669-2.
- Updated systematic review of cognitive behavioural therapy for children and adolescents with obsessive-compulsive disorderLink provided by the sponsor.
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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.
Anne Katrine Pagsberg, Professor principal investigator
Child and Adolescent Mental Health Centre, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Based Cognitive Behavioural Therapy and Family Based Psychoeducation/Relaxation Training in people with Obsessive-Compulsive Disorder in Children and Obsessive-Compulsive Disorder in Adolescence, run by Anne Katrine Pagsberg at 1 site in Denmark.
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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 5 Jul 2024. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score (time frame: Week 0, 4, 8, 16 and 40). 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 NCT03595098, which also lists 3 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 5 Jul 2024.