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Obsessive-compulsive DisorderNCT02541968

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

A study testing Cognitive-behavioral therapy (face-to-face), Internet-based Cognitive-behavioral therapy and Internet-based Cognitive-behavioral therapy without therapist support in people with Obsessive-compulsive Disorder, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obsessive-compulsive Disorder
What is being tested?
Cognitive-behavioral therapy (face-to-face), Internet-based Cognitive-behavioral therapy and Internet-based Cognitive-behavioral therapy without therapist support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSweden
Study dates
3 Sep 2015to 31 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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.

Who cannot join

  • 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,
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Mottagningen för Tvångssyndrom

    Huddinge, 14186

Other trials in Sweden

About this study

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

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.

Read more

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?

Being tested
Cognitive-behavioral therapy (face-to-face), Internet-based Cognitive-behavioral therapy, Internet-based Cognitive-behavioral therapy without therapist support
Medical subject headings
Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive-behavioral therapy (face-to-face)Behavioural

    Also called CBT

  • Internet-based Cognitive-behavioral therapyBehavioural

    Also called ICBT

    With therapist support

  • Internet-based Cognitive-behavioral therapy without therapist supportBehavioural

Study groups in NCT02541968
Study groupRoleWhat they receive
Face-to-face CBTActive comparator16 sessions of individual CBT delivered in 14 weeks.
Receives: Behavioral: Cognitive-behavioral therapy (face-to-face)
Internet-based CBTExperimentalInternet-based CBT (ICBT) with therapist support (14 weeks).
Receives: Behavioral: Internet-based Cognitive-behavioral therapy
ICBT without therapist supportExperimentalInternet-based CBT without therapist support (14 weeks).
Receives: Behavioral: Internet-based Cognitive-behavioral therapy without therapist support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

    Measured: Change from baseline to treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up.

Secondary outcomes (16)

  1. Clinical Global Impression - Severity (CGI-S)

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

  2. Global Assessment of Functioning (GAF)

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

  3. 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

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

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

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

  5. Obsessive-Compulsive Inventory - Revised (OCI-R)

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

  6. Sheehan Disability Scale (SDS)

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

  7. Montgomery-Åsberg Depression Rating Scale - self-rated (MADRS-S)

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

  8. Euroqol (EQ-5D)

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

  9. Clinical Global Impression - Improvement (CGI-I)

    Measured: Treatmentweek 15, 3- and 12-month follow-up.

  10. Insomnia Severity Index (ISI)

    Measured: Treatmentweek 15, 3- and 12-month follow-up.

  11. Treatment credibility scale

    Measured: Change from baseline to treatmentweek 2.

  12. Satisfaction with treatment scale

    Measured: Treatmentweek 15

  13. TiC-P

    Self-rated questionnaire on healthcare utilization and productivity losses in patients with a psychiatric disorder

    Measured: Treatmentweek 0, 15, 3- and 12-month follow-up.

  14. Safety Monitoring Uniform Report Form (SMURF)

    Measured: Treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up.

  15. Patient EX/RP Adherence Scale (PEAS)

    Measured: Treatmentweek 6 and 15

  16. Working Alliance Inventory - short revised

    Measured: Change from baseline to treatment week 6 and 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2015 (estimated)
  2. Study start3 Sep 2015
  3. Primary completionMay 2019
  4. Study completion31 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02541968
Sponsor's protocol ID
OCD F2F vs ICBT
Status last verified
Apr 2022
First submitted
24 Aug 2015
Last updated
22 Apr 2022
Results posted
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25970252

  • 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.

    PubMed 25066102

  • 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.

    PubMed 35285923

  • 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.

    PubMed 30185575

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive-behavioral therapy (face-to-face), Internet-based Cognitive-behavioral therapy and Internet-based Cognitive-behavioral therapy without therapist support in people with Obsessive-compulsive Disorder, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) (time frame: Change from baseline to treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02541968, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.

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