Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder

Obsessive-compulsive Disorder Clinical Trial

Official title:

Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder - a Randomized Controlled Non-inferiority Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541968
• Other study ID #: OCD F2F vs ICBT
• Status: Completed
• Phase: N/A
• Start date: September 3, 2015
• Est. completion date: January 31, 2021

Study information

• Verified date: April 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 31, 2021
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Cognitive-behavioral therapy (face-to-face)

• Internet-based Cognitive-behavioral therapy
With therapist support
• Internet-based Cognitive-behavioral therapy without therapist support

Locations

Country	Name	City	State
Sweden	Mottagningen för Tvångssyndrom	Huddinge

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Andersson E, Hedman E, Enander J, Radu Djurfeldt D, Ljótsson B, Cervenka S, Isung J, Svanborg C, Mataix-Cols D, Kaldo V, Andersson G, Lindefors N, Rück 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. — View Citation

Andersson E, Steneby S, Karlsson K, Ljótsson B, Hedman E, Enander J, Kaldo V, Andersson G, Lindefors N, Rück 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. — View Citation

Lundström L, Flygare O, Andersson E, Enander J, Bottai M, Ivanov VZ, Boberg J, Pascal D, Mataix-Cols D, Rück C. Effect of Internet-Based vs Face-to-Face Cognitive Behavioral Therapy for Adults With Obsessive-Compulsive Disorder: A Randomized Clinical Tria — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)		Change from baseline to treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up.
Secondary	Clinical Global Impression - Severity (CGI-S)		Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
Secondary	Global Assessment of Functioning (GAF)		Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
Secondary	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	Diagnostic status	Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
Secondary	Yale-Brown Obsessive-Compulsive Scale - self-rated (Y-BOCS)		Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
Secondary	Obsessive-Compulsive Inventory - Revised (OCI-R)		Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
Secondary	Sheehan Disability Scale (SDS)		Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
Secondary	Montgomery-Åsberg Depression Rating Scale - self-rated (MADRS-S)		Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
Secondary	Euroqol (EQ-5D)		Change from baseline to treatmentweek 15, 3- and 12-month follow-up.
Secondary	Clinical Global Impression - Improvement (CGI-I)		Treatmentweek 15, 3- and 12-month follow-up.
Secondary	Insomnia Severity Index (ISI)		Treatmentweek 15, 3- and 12-month follow-up.
Secondary	Treatment credibility scale		Change from baseline to treatmentweek 2.
Secondary	Satisfaction with treatment scale		Treatmentweek 15
Secondary	TiC-P	Self-rated questionnaire on healthcare utilization and productivity losses in patients with a psychiatric disorder	Treatmentweek 0, 15, 3- and 12-month follow-up.
Secondary	Safety Monitoring Uniform Report Form (SMURF)		Treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up.
Secondary	Patient EX/RP Adherence Scale (PEAS)		Treatmentweek 6 and 15
Secondary	Working Alliance Inventory - short revised		Change from baseline to treatment week 6 and 15