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

NCT02541968 | Completed

• 1 other identifier: OCD F2F vs ICBT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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?

Conditions

Obsessive-compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Clinical Global Impression - Severity (CGI-S)

  Change from baseline to treatmentweek 15, 3- and 12-month follow-up.

• Global Assessment of Functioning (GAF)

  Change from baseline to treatmentweek 15, 3- and 12-month follow-up.

• 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

  Change from baseline to treatmentweek 15, 3- and 12-month follow-up.

• Yale-Brown Obsessive-Compulsive Scale - self-rated (Y-BOCS)

  Change from baseline to treatmentweek 15, 3- and 12-month follow-up.

• Obsessive-Compulsive Inventory - Revised (OCI-R)

  Change from baseline to treatmentweek 15, 3- and 12-month follow-up.

Study Arms (3)

Face-to-face CBT

ACTIVE COMPARATOR

16 sessions of individual CBT delivered in 14 weeks.

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

Internet-based CBT

EXPERIMENTAL

Internet-based CBT (ICBT) with therapist support (14 weeks).

Behavioral: Internet-based Cognitive-behavioral therapy

ICBT without therapist support

EXPERIMENTAL

Internet-based CBT without therapist support (14 weeks).

Behavioral: Internet-based Cognitive-behavioral therapy without therapist support

Interventions

Cognitive-behavioral therapy (face-to-face) BEHAVIORAL

Also known as: CBT

Face-to-face CBT

Internet-based Cognitive-behavioral therapy BEHAVIORAL

With therapist support

Also known as: ICBT

Internet-based CBT

Internet-based Cognitive-behavioral therapy without therapist support BEHAVIORAL

ICBT without therapist support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Mottagningen för Tvångssyndrom

Huddinge, 14186, Sweden

Location

Related Publications (4)

• 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.

  PMID: 25970252 BACKGROUND

• 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.

  PMID: 25066102 BACKGROUND

• 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.

  PMID: 35285923 RESULT

• 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.

  PMID: 30185575 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christian Rück

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: September 4, 2015
• Study Start: September 3, 2015
• Primary Completion: May 1, 2019
• Study Completion: January 31, 2021
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)