NCT04313439

Brief Summary

The purpose of this pilot study is to investigate if a cognitive treatment targeting obsessive beliefs in patients with aggressive obsessions is feasible and effective as an online treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

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

March 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

March 26, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2021

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

March 12, 2020

Last Update Submit

August 16, 2021

Conditions

Keywords

ObsessionsCognitive therapyInternet

Outcome Measures

Primary Outcomes (1)

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

    Change in obsessions and compulsions from baseline to week 10 and 6 months after treatment has ended. Minimum value is 0. Maximum value is 40. Higher score means more symptoms.

    Week 0, week 10, and 6 months follow up

Secondary Outcomes (10)

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

    Weeks 0 to 10 through treatment and 6 months follow-up

  • Personal Significance Scale (PSS)

    Weeks 0 to 10 through treatment and 6 months follow-up

  • Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)

    Week 0, week 10 and 6 months follow-up

  • Clinical Global Impression (CGI)

    Week 0, week 10 and 6 months follow-up

  • Work and social adjustment scale (WSAS)

    Week 0, week 10 and 6 months follow-up

  • +5 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

Online Cognitive Therapy (I-CT)

Other: Online cognitive therapy (I-CT)

Interventions

The treatment is an online cognitive therapy consisting of a structured self-help program over ten weeks, divided into eight modules, administered in an encrypted web platform. The program is based on the treatment manual "The treatment of Obsessions" by Stanley Rachman. In this treatment, the participant is recommended to perform daily exercises in order to identify and modify interpretations made about the importance of their obsessive thoughts. A designated therapist have email contact with the participant within the encrypted platform.

Treatment

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of OCD taboo thoughts as specified in the DSM-5
  • ≥ 18 years
  • Situated in Sweden
  • Informed consent

You may not qualify if:

  • No signed consent
  • Not fluent speaking in Swedish or cognitive abilities to read written material in the study
  • Adjusted pharmacological treatment the last month symptoms that may affect OCD symptoms
  • Substance dependence during the last six months
  • Psychosis
  • Ongoing mania or hypomania
  • Suicidal risk that may affect study participation
  • Personality disorder that may significantly affect the treatment participation
  • Other ongoing psychological treatments that may affect OCD-symptoms
  • Other primary psychiatric diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 17177, Sweden

Location

MeSH Terms

Conditions

Obsessive-Compulsive DisorderObsessive Behavior

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Erik Andersson, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 12, 2020

First Posted

March 18, 2020

Study Start

March 26, 2020

Primary Completion

February 15, 2021

Study Completion

August 11, 2021

Last Updated

August 17, 2021

Record last verified: 2021-08

Locations