NCT01347099

Brief Summary

Cognitive behavior therapy (CBT) is an effective treatment for obsessive compulsive disorder (OCD) but there is a lack of properly trained CBT therapists. One possible treatment alternative is Internet-based CBT (ICBT) with minimal therapist input. The aim of this study was therefore to evaluate ICBT for OCD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2011

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 21, 2018

Status Verified

May 1, 2011

Enrollment Period

4 months

First QC Date

May 2, 2011

Last Update Submit

March 19, 2018

Conditions

Obsessive Compulsive Disorder

Keywords

CBTOCDInternetReduce symptom burden

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline of obsessions and compulsions after 10 weeks and at 3- and 12 months after treatment.

    Yale Brown Obsessive Compulsive Scale (Y-BOCS)

    Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended

Secondary Outcomes (5)

  • Change from Baseline of obsessions and compulsions after 10 weeks and at 3- and 12 months after treatment.

    Two days before treatment, once per week for 10 weeks after treatment starts, 3 and 12 months after treatment has ended

  • Change from Baseline of obsessions and compulsions after 10 weeks and at 3- and 12 months after treatment.

    Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after the treatment has ended

  • Change from Baseline of depressive symptoms after 10 weeks and at 3- and 12 months after treatment.

    Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended

  • Change from Baseline of meta cognitions after 10 weeks and at 3- and 12 months after treatment.

    Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended

  • Change from Baseline of quality of life after 10 weeks and at 3- and 12 months after treatment.

    Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended

Study Arms (2)

Internet CBT

EXPERIMENTAL

Internet-delivered CBT. Contact with therapist thru an e-mail system. 10 weeks.

Behavioral: Internet-based cognitive behavior therapy

Support therapy

PLACEBO COMPARATOR

10 weeks. Therapist support contact through e-mail.

Behavioral: Support therapy on Internet

Interventions

Internet-based cognitive behavior therapyBEHAVIORAL

Internet-delivered CBT. Contact with therapist thru an e-mail system. 10 weeks

Internet CBT
Support therapy on InternetBEHAVIORAL

Internet-delivered support therapy. Contact with therapist thru an e-mail system. 10 weeks

Support therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary diagnosis of obsessive compulsive disorder (OCD)
  • At least 18 years old
  • Able to read and write in swedish
  • Computer access

You may not qualify if:

  • other primary diagnosis
  • substance abuse,
  • psychosis,
  • bipolar disorder,
  • suicidal ideation,
  • adjusted pharmacological treatment the last two months
  • current psychological treatment for OCD,
  • been treated with CBT the last two years,
  • serious somatic disease,
  • Y---BOCS\>31
  • hoarding as primary OCD subtype

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psykiatri Sydväst

Stockholm, Sweden

Location

Related Publications (1)

  • Andersson E, Enander J, Andren P, Hedman E, Ljotsson B, Hursti T, Bergstrom J, Kaldo V, Lindefors N, Andersson G, Ruck C. Internet-based cognitive behaviour therapy for obsessive-compulsive disorder: a randomized controlled trial. Psychol Med. 2012 Oct;42(10):2193-203. doi: 10.1017/S0033291712000244. Epub 2012 Feb 21.

    PMID: 22348650RESULT

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Christian Rück, MD, PhD

    Department of Clinical Neuroscience, KI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2011

First Posted

May 4, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 21, 2018

Record last verified: 2011-05

Locations

SE(1)