Clinical trial NCT04313439: Targeting Taboo Thoughts In Obsessive-Compulsive Disorder
Official title: Targeting Taboo Thoughts In Obsessive-Compulsive Disorder Using Internet- Delivered Cognitive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Obsessions
Cognitive therapy
Internet
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The clinician rated Yale Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: Week 0, week 10, and 6 months follow up
Secondary outcomes:
measure: The self-rated Yale Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: Weeks 0 to 10 through treatment and 6 months follow-up
measure: Personal Significance Scale (PSS)
timeFrame: Weeks 0 to 10 through treatment and 6 months follow-up
measure: Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)
timeFrame: Week 0, week 10 and 6 months follow-up
measure: Clinical Global Impression (CGI)
timeFrame: Week 0, week 10 and 6 months follow-up
measure: Work and social adjustment scale (WSAS)
timeFrame: Week 0, week 10 and 6 months follow-up
measure: Thought Action Fusion Scale (TAFS)
timeFrame: Week 0, week 10 and 6 months follow-up
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: Week 0, week 10 and 6 months follow-up
measure: Meta-Cognitive Questionnaire (Negative metacognitions subscale; MCQ-NC)
timeFrame: Week 0, week 10 and 6 months follow-up
measure: Patient Satisfaction Questionnaire (PSQ)
timeFrame: Week 10
measure: Adverse events (AE)
timeFrame: Weeks 0 to 10 through treatment and 6 months follow-up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Erik Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References: