Obsessive-Compulsive DisorderNCT04313439
Targeting Taboo Thoughts In Obsessive-Compulsive Disorder
A study testing Online cognitive therapy (I-CT) in people with Obsessive-Compulsive Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Online cognitive therapy (I-CT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSweden
- Study dates
- 26 Mar 2020to 11 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of OCD taboo thoughts as specified in the DSM-5
- ≥ 18 years
- Situated in Sweden
- Informed consent
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Online cognitive therapy (I-CT)
- Keywords
- Obsessions, Cognitive therapy, Internet
- Medical subject headings
- Obsessive-Compulsive Disorder, Obsessive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online cognitive therapy (I-CT)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Online Cognitive Therapy (I-CT) Receives: Other: Online cognitive therapy (I-CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0, week 10, and 6 months follow up
Secondary outcomes (10)
The self-rated Yale Brown Obsessive Compulsive Scale (Y-BOCS)
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.
Measured: Weeks 0 to 10 through treatment and 6 months follow-up
Personal Significance Scale (PSS)
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.
Measured: Weeks 0 to 10 through treatment and 6 months follow-up
Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)
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.
Measured: Week 0, week 10 and 6 months follow-up
Clinical Global Impression (CGI)
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.
Measured: Week 0, week 10 and 6 months follow-up
Work and social adjustment scale (WSAS)
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.
Measured: Week 0, week 10 and 6 months follow-up
Thought Action Fusion Scale (TAFS)
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.
Measured: Week 0, week 10 and 6 months follow-up
Penn State Worry Questionnaire (PSWQ)
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.
Measured: Week 0, week 10 and 6 months follow-up
Meta-Cognitive Questionnaire (Negative metacognitions subscale; MCQ-NC)
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.
Measured: Week 0, week 10 and 6 months follow-up
Patient Satisfaction Questionnaire (PSQ)
Satisfaction of treatment at week 10. Qualitative questions.
Measured: Week 10
Adverse events (AE)
Number of adverse events every week during treatment and post treatment week 10.
Measured: Weeks 0 to 10 through treatment and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start26 Mar 2020
- Primary completion15 Feb 2021
- Study completion11 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Andersson, Karolinska Institutet
- Investigators
- Erik Andersson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313439
- Sponsor's protocol ID
- EPN Dnr 2019-06047
- Status last verified
- Aug 2021
- First submitted
- 12 Mar 2020
- Last updated
- 17 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Taboo Thoughts In Obsessive-Compulsive Disorder Using Internet- Delivered Cognitive Therapy
- ClinicalTrials.gov ID
- NCT04313439
- Acronym / sponsor ID
- EPN Dnr 2019-06047
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessions, Cognitive therapy, Internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 26 Mar 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 11 Aug 2021 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Online cognitive therapy (I-CT)Online Cognitive Therapy (I-CT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of OCD taboo thoughts as specified in the DSM-5
- ≥ 18 years
- Situated in Sweden
- Informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Treatment |
Primary outcome
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.
10 secondary outcomes
The self-rated Yale Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: 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
Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)
Time frame: Week 0, week 10 and 6 months follow-up
Clinical Global Impression (CGI)
Time frame: 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
Thought Action Fusion Scale (TAFS)
Time frame: 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
Meta-Cognitive Questionnaire (Negative metacognitions subscale; MCQ-NC)
Time frame: Week 0, week 10 and 6 months follow-up
Patient Satisfaction Questionnaire (PSQ)
Time frame: Week 10
Adverse events (AE)
Time frame: Weeks 0 to 10 through treatment and 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
Related trials for Obsessive-Compulsive Disorder
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
Recruiting
tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder
Obsessive-Compulsive Disorder
Recruiting
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
Mindfulness Skills, Psychosocial Education
Not yet recruiting
tDCS and Symptom Provocation in Treatment-Resistant OCD
Obsessive - Compulsive Disorder
RecruitingPhase 2
SONATA Dose Duration LIFU for OCD
Obsessive - Compulsive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Andersson, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online cognitive therapy (I-CT) in people with Obsessive-Compulsive Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinician rated Yale Brown Obsessive Compulsive Scale (Y-BOCS) (time frame: Week 0, week 10, and 6 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.