Clinical trial NCT02541968: Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder
Official title: Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder - a Randomized Controlled Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-compulsive Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Randomized controlled non-inferiority trial comparing therapist-guided Internet-based Cognitive behavioral therapy (ICBT), self-guided ICBT, and individual face-to-face (f2f) CBT for Obsessive-Compulsive Disorder (OCD) in adults.

The primary objective is to evaluate whether ICBT is a non-inferior treatment option compared to the best possible available treatment for OCD, individual face to face (f2f) CBT. A second objective is to compare the efficacy of self-guided vs. therapist-guided ICBT. As this question has cost implications for the health system, a third objective is to carry out a health economic evaluation of both forms of ICBT, in relation to the gold standard f2f CBT. A fourth objective is to explore whether ICBT is equally suited for clinic-referred cases compared to self-referred patients. Finally, a fifth objective is to investigate whether genetic markers, in combination with clinical variables, can be employed to predict treatment outcomes with CBT in general.

Research Questions:

Q1: Is therapist-guided internet-based CBT (ICBT) for OCD non-inferior to face-to-face (f2f) CBT with regard to OCD symptoms, function and quality of life?

Q2: Is entirely self-guided ICBT non-inferior to f2f CBT with regard to OCD symptoms, function and quality of life?

Q3: Is ICBT a cost-effective treatment, compared to f2f CBT?

Q4: Is there a difference in treatment outcome between self-referred and clinical referred patients?

Q5: Can clinical variables and genetic markers be useful to predict which patients will benefit from CBT?


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age,
* Internet access,
* primary diagnosis of OCD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5),
* Written consent of participation in the study.

Exclusion Criteria:

* Other psychological treatment for OCD during the treatment period,
* Adjustment of concurrent psychotropic medication within the last two months,
* bipolar disorder,
* psychosis,
* alcohol or substance dependence,
* completed CBT for OCD in the last 12 months,
* hoarding disorder or OCD with primary hoarding symptoms,
* suicidal ideation,
* subjects that lack the ability to read written Swedish or lack the cognitive ability to assimilate to the written material,
* Autism spectrum disorder,
* organic brain disorder.

Primary outcomes:
measure: Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
timeFrame: Change from baseline to treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up.
Secondary outcomes:
measure: Clinical Global Impression - Severity (CGI-S)
timeFrame: Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
measure: Global Assessment of Functioning (GAF)
timeFrame: Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
measure: Structured Clinical Interview for DSM-5 (SCID-5) obsessive-compulsive and related disorders Structured Clinical Interview for DSM-5 (SCID-5) obsessive-compulsive and related disorders
timeFrame: Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
measure: Yale-Brown Obsessive-Compulsive Scale - self-rated (Y-BOCS)
timeFrame: Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
measure: Obsessive-Compulsive Inventory - Revised (OCI-R)
timeFrame: Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
measure: Sheehan Disability Scale (SDS)
timeFrame: Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
measure: Montgomery-Åsberg Depression Rating Scale - self-rated (MADRS-S)
timeFrame: Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
measure: Euroqol (EQ-5D)
timeFrame: Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
measure: Clinical Global Impression - Improvement (CGI-I)
timeFrame: Treatmentweek 15, 3- and 12-month follow-up.
measure: Insomnia Severity Index (ISI)
timeFrame: Treatmentweek 15, 3- and 12-month follow-up.
measure: Treatment credibility scale
timeFrame: Change from baseline to treatmentweek 2.
measure: Satisfaction with treatment scale
timeFrame: Treatmentweek 15
measure: TiC-P
timeFrame: Treatmentweek 0, 15, 3- and 12-month follow-up.
measure: Safety Monitoring Uniform Report Form (SMURF)
timeFrame: Treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up.
measure: Patient EX/RP Adherence Scale (PEAS)
timeFrame: Treatmentweek 6 and 15
measure: Working Alliance Inventory - short revised
timeFrame: Change from baseline to treatment week 6 and 15
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Mottagningen för Tvångssyndrom
Study officials:
affiliation: Karolinska Institutet
name: Christian Rück
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersson E, Hedman E, Enander J, Radu Djurfeldt D, Ljotsson B, Cervenka S, Isung J, Svanborg C, Mataix-Cols D, Kaldo V, Andersson G, Lindefors N, Ruck C. D-Cycloserine vs Placebo as Adjunct to Cognitive Behavioral Therapy for Obsessive-Compulsive Disorder and Interaction With Antidepressants: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Jul;72(7):659-67. doi: 10.1001/jamapsychiatry.2015.0546.
citation: Andersson E, Steneby S, Karlsson K, Ljotsson B, Hedman E, Enander J, Kaldo V, Andersson G, Lindefors N, Ruck C. Long-term efficacy of Internet-based cognitive behavior therapy for obsessive-compulsive disorder with or without booster: a randomized controlled trial. Psychol Med. 2014 Oct;44(13):2877-87. doi: 10.1017/S0033291714000543. Epub 2014 Mar 14.
citation: Lundstrom L, Flygare O, Andersson E, Enander J, Bottai M, Ivanov VZ, Boberg J, Pascal D, Mataix-Cols D, Ruck C. Effect of Internet-Based vs Face-to-Face Cognitive Behavioral Therapy for Adults With Obsessive-Compulsive Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e221967. doi: 10.1001/jamanetworkopen.2022.1967.
citation: Ruck C, Lundstrom L, Flygare O, Enander J, Bottai M, Mataix-Cols D, Andersson E. Study protocol for a single-blind, randomised controlled, non-inferiority trial of internet-based versus face-to-face cognitive behaviour therapy for obsessive-compulsive disorder. BMJ Open. 2018 Sep 5;8(9):e022254. doi: 10.1136/bmjopen-2018-022254.