Kristina Aspvall1,2, Erik Andersson3, Karin Melin4,5, Lisa Norlin5, Viktor Eriksson2, Sarah Vigerland1,2, Maral Jolstedt1,2, Maria Silverberg-Mörse2, Lena Wallin5,6, Filipa Sampaio7, Inna Feldman7, Matteo Bottai8, Fabian Lenhard1, David Mataix-Cols1,2, Eva Serlachius1,2. 1. Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden. 2. Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden. 3. Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. 4. Institute Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. 5. Region Västra Götaland, Department of Child and Adolescent Psychiatry, Sahlgrenska University Hospital, Gothenburg, Sweden. 6. Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. 7. Department of Public Health and Caring Sciences, Uppsala Universitet, Uppsala, Sweden. 8. Divison of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.
Abstract
Importance: In most countries, young people with obsessive-compulsive disorder have limited access to specialist cognitive behavioral therapy (CBT), a first-line treatment. Objective: To investigate whether internet-delivered CBT implemented in a stepped-care model is noninferior to in-person CBT for pediatric obsessive-compulsive disorder. Design, Setting and Participants: A randomized clinical noninferiority trial conducted at 2 specialist child and adolescent mental health clinics in Sweden. Participants included 152 individuals aged 8 to 17 years with obsessive-compulsive disorder. Enrollment began in October 2017 and ended in May 2019. Follow-up ended in April 2020. Interventions: Participants randomized to the stepped-care group (n = 74) received internet-delivered CBT for 16 weeks. Nonresponders at the 3-month follow-up were then offered a course of traditional face-to-face treatment. Participants randomized to the controlgroup (n = 78) immediately received in-person CBT for 16 weeks. Nonresponders at the 3-month follow-up received additional face-to-face treatment. Main Outcomes and Measures: The primary outcome was the masked assessor-rated Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score at the 6-month follow-up. The scale includes 10 items rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total score range of 0 to 40, with higher scores indicating greater severity. Assessors were masked to treatment allocation at pretreatment, posttreatment, 3-month follow-up, and 6-month follow-up assessments. The predefined noninferiority margin was 4 points on the CY-BOCS. Results: Among the 152 randomized participants (mean age, 13.4 years; 94 [62%] females), 151 (99%) completed the trial. At the 3-month follow-up, 34 participants (46%) in the stepped-care group and 23 (30%) in the in-person CBT group were nonresponders. At the 6-month follow-up, the CY-BOCS score was 11.57 points in the stepped-care group vs 10.57 points in the face-to-face treatment group, corresponding to an estimated mean difference of 0.91 points ([1-sided 97.5% CI, -∞ to 3.28]; P for noninferiority = .02). Increased anxiety (30%-36%) and depressive symptoms (20%-28%) were the most frequently reported adverse events in both groups. There were 2 unrelated serious adverse events (1 in each group). Conclusions and Relevance: Among children and adolescents with obsessive-compulsive disorder, treatment with an internet-delivered CBT program followed by in-person CBT if necessary compared with in-person CBT alone resulted in a noninferior difference in symptoms at the 6-month follow-up. Further research is needed to understand the durability and generalizability of these findings. Trial Registration: ClinicalTrials.gov Identifier: NCT03263546.
RCT Entities:
Importance: In most countries, young people with obsessive-compulsive disorder have limited access to specialist cognitive behavioral therapy (CBT), a first-line treatment. Objective: To investigate whether internet-delivered CBT implemented in a stepped-care model is noninferior to in-person CBT for pediatric obsessive-compulsive disorder. Design, Setting and Participants: A randomized clinical noninferiority trial conducted at 2 specialist child and adolescent mental health clinics in Sweden. Participants included 152 individuals aged 8 to 17 years with obsessive-compulsive disorder. Enrollment began in October 2017 and ended in May 2019. Follow-up ended in April 2020. Interventions: Participants randomized to the stepped-care group (n = 74) received internet-delivered CBT for 16 weeks. Nonresponders at the 3-month follow-up were then offered a course of traditional face-to-face treatment. Participants randomized to the control group (n = 78) immediately received in-person CBT for 16 weeks. Nonresponders at the 3-month follow-up received additional face-to-face treatment. Main Outcomes and Measures: The primary outcome was the masked assessor-rated Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score at the 6-month follow-up. The scale includes 10 items rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total score range of 0 to 40, with higher scores indicating greater severity. Assessors were masked to treatment allocation at pretreatment, posttreatment, 3-month follow-up, and 6-month follow-up assessments. The predefined noninferiority margin was 4 points on the CY-BOCS. Results: Among the 152 randomized participants (mean age, 13.4 years; 94 [62%] females), 151 (99%) completed the trial. At the 3-month follow-up, 34 participants (46%) in the stepped-care group and 23 (30%) in the in-person CBT group were nonresponders. At the 6-month follow-up, the CY-BOCS score was 11.57 points in the stepped-care group vs 10.57 points in the face-to-face treatment group, corresponding to an estimated mean difference of 0.91 points ([1-sided 97.5% CI, -∞ to 3.28]; P for noninferiority = .02). Increased anxiety (30%-36%) and depressive symptoms (20%-28%) were the most frequently reported adverse events in both groups. There were 2 unrelated serious adverse events (1 in each group). Conclusions and Relevance: Among children and adolescents with obsessive-compulsive disorder, treatment with an internet-delivered CBT program followed by in-person CBT if necessary compared with in-person CBT alone resulted in a noninferior difference in symptoms at the 6-month follow-up. Further research is needed to understand the durability and generalizability of these findings. Trial Registration: ClinicalTrials.gov Identifier: NCT03263546.
Authors: Rebecca Mortazavi; Maria Lalouni; Rebecca Grudin; Eva Serlachius; Carl Johan Sundberg; Jessica Norrbom; Ingrid Larsson; Emma Haglund; Andreas Ivarsson; Fabian Lenhard; Tina Cronqvist; Kristina Ingemarsson; Åsa Mårsell; Olof Rask; Håkan Jarbin Journal: BMJ Open Date: 2022-07-12 Impact factor: 3.006
Authors: Frida Wickberg; Fabian Lenhard; Kristina Aspvall; Eva Serlachius; Per Andrén; Fred Johansson; Maria Silverberg-Mörse; David Mataix-Cols Journal: Internet Interv Date: 2022-03-04
Authors: Kristina Aspvall; Filipa Sampaio; Fabian Lenhard; Karin Melin; Lisa Norlin; Eva Serlachius; David Mataix-Cols; Erik Andersson Journal: JAMA Netw Open Date: 2021-07-01