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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Face-to-face CBT | Active Comparator | 16 sessions of individual CBT delivered in 14 weeks. |
|
| Internet-based CBT | Experimental | Internet-based CBT (ICBT) with therapist support (14 weeks). |
|
| ICBT without therapist support | Experimental | Internet-based CBT without therapist support (14 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-behavioral therapy (face-to-face) | Behavioral |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Rück | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mottagningen för Tvångssyndrom | Huddinge | 14186 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25970252 | Background | 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. | |
| 25066102 |
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| Internet-based Cognitive-behavioral therapy |
| Behavioral |
With therapist support |
|
|
| Internet-based Cognitive-behavioral therapy without therapist support | Behavioral |
|
| 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. |
| 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. |
| Sheehan Disability Scale (SDS) | Change from baseline to treatmentweek 15, 3- and 12-month follow-up. |
| Montgomery-Åsberg Depression Rating Scale - self-rated (MADRS-S) | Change from baseline to treatmentweek 15, 3- and 12-month follow-up. |
| Euroqol (EQ-5D) | Change from baseline to treatmentweek 15, 3- and 12-month follow-up. |
| Clinical Global Impression - Improvement (CGI-I) | Treatmentweek 15, 3- and 12-month follow-up. |
| Insomnia Severity Index (ISI) | Treatmentweek 15, 3- and 12-month follow-up. |
| Treatment credibility scale | Change from baseline to treatmentweek 2. |
| Satisfaction with treatment scale | Treatmentweek 15 |
| 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. |
| Safety Monitoring Uniform Report Form (SMURF) | Treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up. |
| Patient EX/RP Adherence Scale (PEAS) | Treatmentweek 6 and 15 |
| Working Alliance Inventory - short revised | Change from baseline to treatment week 6 and 15 |
| 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. |
| 35285923 | Result | 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. |
| 30185575 | Derived | 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. |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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