Targeting Taboo Thoughts In Obsessive-Compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04313439
• Other study ID #: EPN Dnr 2019-06047
• Status: Completed
• Phase: N/A
• Start date: March 26, 2020
• Est. completion date: August 11, 2021

Study information

• Verified date: August 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 11, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 0, week 10, and 6 months follow up
Secondary	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.	Weeks 0 to 10 through treatment and 6 months follow-up
Secondary	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.	Weeks 0 to 10 through treatment and 6 months follow-up
Secondary	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.	Week 0, week 10 and 6 months follow-up
Secondary	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.	Week 0, week 10 and 6 months follow-up
Secondary	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.	Week 0, week 10 and 6 months follow-up
Secondary	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.	Week 0, week 10 and 6 months follow-up
Secondary	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.	Week 0, week 10 and 6 months follow-up
Secondary	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.	Week 0, week 10 and 6 months follow-up
Secondary	Patient Satisfaction Questionnaire (PSQ)	Satisfaction of treatment at week 10. Qualitative questions.	Week 10
Secondary	Adverse events (AE)	Number of adverse events every week during treatment and post treatment week 10.	Weeks 0 to 10 through treatment and 6 months follow-up