Treatment Effects of Family Based Cognitive Therapy in Children and Adolescents With Obsessive Compulsive Disorder

Obsessive-Compulsive Disorder in Adolescence Clinical Trial

— TECTO  

Official title:

Treatment Effects of Family Based Cognitive Therapy in Children and Adolescents With Obsessive Compulsive Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03595098
• Other study ID #: TECTO-Trial-DP-395
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 28, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: Copenhagen Trial Unit, Center for Clinical Intervention Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The aim is to conduct this investigation in an optimal trial design with the lowest possible risk of bias.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: June 30, 2024
• Est. primary completion date: April 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder
• Obsessive-Compulsive Disorder in Adolescence
• Obsessive-Compulsive Disorder in Children

Intervention

Behavioral:
• Family Based Cognitive Behavioural Therapy
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 Training
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.

Locations

Country	Name	City	State
Denmark	Child and Adolescent Mental Health Centre, Bispebjerg	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Anne Katrine Pagsberg	Copenhagen Trial Unit, Center for Clinical Intervention Research, Danish Research Centre for Magnetic Resonance

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Magnetic resonance imaging	This is exploratory outcome. Magnetic resonance imaging (MRI) is used to obtain images of the patients' brains before and after treatment and the scanning consists of both structural and functional scans. From the functional scans response-inhibition-related and switch-related activity during Stop Signal Task performance and Task Switching performance is examined.	Week 0 and 16
Other	Family Accommodation Scale	This is exploratory outcome showing family factors. Family Accommodation Scale (FAS): a 13-item parent-report measure designed to assess accommodation of a child's OCD-related behaviors over the previous month. In an effort to assess multiple dimensions to accommodations (rather than one in isolation), items are anchored with respect to either frequency or magnitude utilizing a 5-pt Likert scale ranging from 0 (Never) to 4 (Daily) with higher scores indicating greater parental accommodation.	Week 4, 8, 16 and 40
Other	Family Environment Scale	This is exploratory outcome showing family factors. Family Environment Scale (FES)is composed of 90 items and 10 subscales that measure actual, preferred, and expected family social environments. The 10 subscales assess three dimensions: relationship dimensions, personal growth (or goal orientation) dimensions, and system maintenance dimensions. There are three FES forms (real, ideal, and expectations); only the FES real form will be used, which examines a family member's perception of the family as it is. The scale ranges from 10 to 40, with a score of 10 being representative of no family conflict and a score of 40 being representative of the greatest magnitude of family conflict. Therefore, a decrease in score represents a decrease in self-reported family conflict.	Week 0
Other	Parental Stress Scale	This is exploratory outcome showing family factors. Parental Stress Scale (PSS)measures parental stress in the parental relationship and consists of 18 items. The parent answers different statements about his or her relationship to the child by scoring each item on a five-point Likert-scale (1-5), 5 representing the highest amount of agreement with the statement and 1 representing the highest amount of dis-agreement. The positively formulated items are scored in reverse. PSS is thus scored on a scale from 18 to 90, where higher scores reflect greater stress.	Week 4, 8, 16 and 40
Other	Child Obsessive-Compulsive Impact Scale	This is exploratory clinical outcome.Child Obsessive-Compulsive Impact Scale (COIS) is a 33-item parent-report and self-report questionnaire that assesses OCD-related impairment in various areas of the child's life, including school, social, and home/family activities. For each item, the respondent rates the child's level of impairment on a 4-point Likert scale from 0 (not at all) to 3 (very much). The total score (0-99) is the sum of the item scores. Higher scores reflect more severe impairment.	Week 4, 8, 16 and 40
Other	Clinical Global Impression Severity and Clinical Global Impression Improvement Scale	This is exploratory clinical outcome. Clinical Global Impression Severity and Clinical Global Impression Improvement Scale (CGI-I and CGI-S) measure symptom severity, treatment response, and the efficacy of treatments in treatment studies of patients with mental disorders. Therefore higher scores indicate a worse mental state of the patient. The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-I scores range from 1 (very much improved) through to 7 (very much worse).	Week 4, 8, 16 and 40
Other	Occurrence of Serious Adverse Events	This is exploratory clinical outcome. Occurrence of Serious Adverse Events.Any adverse events such as results in death, is life-threatening, requires hospitalisation or prolongs existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect, which does not necessarily have a causal relationship with the intervention will be registered register.	Week 0-Week 40
Other	Children's Global Assessment Scale	This is exploratory clinical outcome. Children's Global Assessment Scale Scale is a numeric scale used by mental health clinicians to rate the general functioning of youths under the age of 18. It is the 100-point single-item score, scored from 0-100 (worse to normal).	Week 4, 8, 16 and 40
Other	Remission	This is exploratory clinical outcome. Proportion of patients no longer meeting the diagnostic criteria for OCD, ICD-10 F.42 assessed with Schedule for Affective Disorders and Schizophrenia for school-aged children, Present and Lifetime version (K-SADS-PL) at the end of the intervention (remission).	Week 16
Other	OCD symptoms remission	This is exploratory clinical outcome.This is a binary, exploratory, clinical outcome. Treatment response based on the definition of a reduction in CY-BOCS score at week 16 of at least 30% in intraindividual comparison with the score at week 0.	Week 16
Other	Toronto Obsessive-Compulsive Rating Scale	This is an exploratory clinical outcome. Toronto Obsessive-Compulsive Rating Scale (TOCS) is a quantitative and multidimensional measure of Obsessive-Compulsive traits in children and adolescents. Questionnaire with 21 items, and each item is scored on a 7-point likert scale from -3 to 3. Dimension scores ranges from -3 to 3. The total scale ranges from -63 to 63. Higher values represents worse outcome.	Week 0 and week 16
Other	Risk taking and decision-making ability	This is exploratory cognition outcome. Risk taking and decision-making assessed by Cambridge Gambling Task	Week 0 and week 16th
Other	Planning ability	This is exploratory cognition outcome. Planning ability assessed by Stockings of Cambridge test. It is a computerized neuropsychological test assessing executive functions. There are two main outcomes: Reaction time and accuracy. Low reaction time combined with high accuracy represents better planning ability.	Week 0 and week 16th
Other	Working memory capacity	This is exploratory cognition outcome. Working memory capacity assessed by Spatial Working Memory test. It requires retention and manipulation of visuospatial information. This self-ordered test has notable executive function demands and provides a measure of strategy as well as working memory errors. Reaction time and accuracy. Low reaction time combined with high accuracy represents better memory capacity.	Week 0 and week 16th
Other	Motor skills	This is an exploratory cognition outcome. Motor skills assessed with Purdue Pegboard test. It controls for potential effects of differences in motor skills on performance on other tasks in the battery. Test is a rectangular board with 2 sets of 25 holes running vertically and 4 concave cups at the top. Small metal pegs are placed in the cup on the side being tested, with subjects asked to remove the pegs and place them vertically in the holes as rapidly as possible. The number of pegs placed in 30 seconds is scored. More accurate placed pegs represent better motor skills.	Week 0 and week 16th
Other	Habit formation	This is exploratory cognition outcome. Weather Prediction Learning Task, which is a probabilistic classification learning task in which participants learn to predict the weather (i.e. "sun" or "rain" outcomes) based on combinations of cues that predict "sun" versus "rain" outcomes. Better prediction mean better outcome.	Week 0 and week 16th
Other	Change in Delis-Kaplan Executive Function System (D-KEFS)	This is an exploratory cognition outcome.The Delis-Kaplan Executive Function System (DKEFS). Test three tests from D-KEFS will be used: Trail Making, Verbal Fluency, and Design Fluency. The three test measures set-shifting ability, processing speed, and response inhibition. Each test has a scaled score going from 1-19, where higher values represent better outcome.	Week 0 and week 16th
Other	Change in Thought-Action Fusion Questionnaire for Adolescents	This is exploratory outcome. Thought-Action Fusion Questionnaire for Adolescents (TAFQ-A): a 15-item questionnaire measuring cognitive biases that are thought to play an important role in the development of obsessions. Each item is scored on a 4-point likert scale from 1-4, were higher values represent worse outcome.	Week 0, 4, 8, 16 and 40
Other	Executive function	This is exploratory outcome. Behaviour Rating Inventory of Executive Function: a self-report and parent-report questionnaire assessing impairment of executive function. Executive function in daily life (range:70-210). Higher score indicate greater executive dysfunction.	Week 0 and week 16
Primary	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.	Week 0, 4, 8, 16 and 40
Secondary	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.	Week 0, 4, 8, 16 and 40
Secondary	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.	Week 4, 8, 16 and 40

External Links

•   Updated systematic review of cognitive behavioural therapy for children and adolescents with obsessive-compulsive disorder