NCT01525576

Brief Summary

In this trial, we test if adding an Internet-based booster program to regular Internet-based cognitive behavior therapy (ICBT) is effective for patients with obsessive-compulsive disorder (OCD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2012

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

First Submitted

Initial submission to the registry

February 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 31, 2012

Status Verified

July 1, 2012

Enrollment Period

5 months

First QC Date

February 1, 2012

Last Update Submit

July 30, 2012

Conditions

Keywords

booster programinternetcbtStudy the specific effects of adding a booster program

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline of obsessions and compulsions after 3, 8 and 20 months after baseline.

    Yale Brown Obsessive Compulsive Scale (Y-BOCS). Analysis will examine the frequency of relapse from remission between the groups. Furthermore, frequency of incremental cases of remission will be compared between the groups.

    3 months before treatment, 3 weeks after treatment starts, 6 and 18 months after treatment has ended

Secondary Outcomes (4)

  • Change from Baseline of obsessions and compulsions after 8 and 20 months.

    3 months before treatment, 6 and 18 months after treatment has ended

  • Change from Baseline of obsessions and compulsions after 8 and 20 months.

    3 months before treatment, 6 and 18 months after treatment has ended

  • Change from Baseline of obsessions and compulsions after 8 and 20 months.

    3 months before treatment, 6 and 18 months after treatment has ended

  • Change from Baseline of obsessions and compulsions after 8 and 20 months.

    3 months before treatment, 6 and 18 months after treatment has ended

Study Arms (2)

Control group

NO INTERVENTION

No offer of booster program.

Booster

EXPERIMENTAL

3 week booster program + 2 additional weeks two months later for follow-up.

Behavioral: Booster

Interventions

BoosterBEHAVIORAL

3 week booster program + 2 additional weeks two months later for follow-up.

Booster

Eligibility Criteria

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

You may qualify if:

  • Signed consent
  • Previously enrolled in our randomized controlled trial testing ICBT for OCD: NCT01347099

You may not qualify if:

  • Suicidal ideation that could jeopardize participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psykiatri sydväst

Stockholm, Sweden

Location

Related Links

MeSH Terms

Conditions

Obsessive-Compulsive DisorderColor Vision Defects

Interventions

Immunization, Secondary

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersVision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesCone DystrophyEye Diseases, HereditaryEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Christian Ruck

Study Record Dates

First Submitted

February 1, 2012

First Posted

February 3, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 31, 2012

Record last verified: 2012-07

Locations