Targeting Taboo Thoughts In Obsessive-Compulsive Disorder

Not Applicable

Completed

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Other: Online cognitive therapy (I-CT)

• Registration Number: NCT04313439
• Lead Sponsor: Karolinska Institutet

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-18
• Study Start: 2020-03-26
• Primary Completion: 2021-02-15
• Status Verified: 2021-08
• Study Completion: 2021-08-11
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Online cognitive therapy (I-CT)	Online Cognitive Therapy (I-CT)

Primary Outcome Measures

Name	Time	Method
The clinician rated Yale Brown Obsessive Compulsive Scale (Y-BOCS)	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression (CGI)	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.
The self-rated Yale Brown Obsessive Compulsive Scale (Y-BOCS)	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.
Penn State Worry Questionnaire (PSWQ)	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.
Patient Satisfaction Questionnaire (PSQ)	Week 10	Satisfaction of treatment at week 10. Qualitative questions.
Personal Significance Scale (PSS)	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.
Work and social adjustment scale (WSAS)	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.
Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)	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.
Thought Action Fusion Scale (TAFS)	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.
Meta-Cognitive Questionnaire (Negative metacognitions subscale; MCQ-NC)	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.
Adverse events (AE)	Weeks 0 to 10 through treatment and 6 months follow-up	Number of adverse events every week during treatment and post treatment week 10.

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden