Targeting Taboo Thoughts In Obsessive-Compulsive Disorder

August 16, 2021 updated by: Erik Andersson, Karolinska Institutet

Targeting Taboo Thoughts In Obsessive-Compulsive Disorder Using Internet- Delivered Cognitive Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with obsessive-compulsive disorder who presents with aggressive obsessions (also known as taboo thoughts e.g. fear of being a pedophile) and mental rituals have shown to respond less well to treatment. Thus, there is room for further innovation. The primary objective of this pilot study is to investigate if an internet-based cognitive therapy (I-CT) is feasible and effective in reducing the frequency and distress of aggressive obsessions. The study will also investigate if I-CT is associated with any significant side effects. Another objective of this study is to get a power estimate of the treatment effects for a subsequent randomized controlled study (RCT). This will be done by using an open pilot study with repeated measurements.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17177
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Online Cognitive Therapy (I-CT)
Other: Online cognitive therapy (I-CT)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The clinician rated Yale Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame: Week 0, week 10, and 6 months follow up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The self-rated Yale Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame: Weeks 0 to 10 through treatment and 6 months follow-up
Change in obsessions and compulsions from baseline, during treatment to week 10 and at 6 after treatment has ended. Minimum value is 0. Maximum value is 40. Higher score means more symptoms.
Weeks 0 to 10 through treatment and 6 months follow-up
Personal Significance Scale (PSS)
Time Frame: Weeks 0 to 10 through treatment and 6 months follow-up
Change in perceived personal significance of intrusive thougths from baseline, during treatment to week 10 and at 6 months after treatment has ended. Minimum value is 0. Maximum value is 80. Higher score means more symptoms.
Weeks 0 to 10 through treatment and 6 months follow-up
Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)
Time Frame: Week 0, week 10 and 6 months follow-up
Change in depression from baseline to week 10 and at 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
Clinical Global Impression (CGI)
Time Frame: Week 0, week 10 and 6 months follow-up
Change in symptom severity from baseline to week 10 and 6 months after treatment has ended, and treatment response and the efficacy of treatments at week 10 and 6 months after treatment after treatment has ended. Rated by the psychologist. Minimum value is 0. Maximum value is 6. Higher score means less improvement.
Week 0, week 10 and 6 months follow-up
Work and social adjustment scale (WSAS)
Time Frame: Week 0, week 10 and 6 months follow-up
Change in functional impairment 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
Thought Action Fusion Scale (TAFS)
Time Frame: Week 0, week 10 and 6 months follow-up
Change in maladaptive cognitive intrusions from baseline to week 10 and 6 months after treatment has ended. Minimum value is 0. Maximum value is 76. Higher score means more symptoms.
Week 0, week 10 and 6 months follow-up
Penn State Worry Questionnaire (PSWQ)
Time Frame: Week 0, week 10 and 6 months follow-up
Change in worry from baseline to week 10 and 6 months after treatment has ended. Minimum value is 0. Maximum value is 80. Higher score means more symptoms.
Week 0, week 10 and 6 months follow-up
Meta-Cognitive Questionnaire (Negative metacognitions subscale; MCQ-NC)
Time Frame: Week 0, week 10 and 6 months follow-up
Change in negative meta-cognitions about worrying from baseline to week 10 and 6 months after treatment has ended. Minimum value is 0. Maximum value is 24. Higher score means more symptoms.
Week 0, week 10 and 6 months follow-up
Patient Satisfaction Questionnaire (PSQ)
Time Frame: Week 10
Satisfaction of treatment at week 10. Qualitative questions.
Week 10
Adverse events (AE)
Time Frame: Weeks 0 to 10 through treatment and 6 months follow-up
Number of adverse events every week during treatment and post treatment week 10.
Weeks 0 to 10 through treatment and 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Erik Andersson, PhD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2020

Primary Completion (Actual)

February 15, 2021

Study Completion (Actual)

August 11, 2021

Study Registration Dates

First Submitted

March 12, 2020

First Submitted That Met QC Criteria

March 16, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 16, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPN Dnr 2019-06047

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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