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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 11, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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