Targeting Taboo Thoughts In Obsessive-Compulsive Disorder

Karolinska Institutet19 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obsessive-Compulsive Disorder

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Karolinska Institutet

Stockholm, Sweden

Outcomes

Primary Outcomes

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.

Time frame: Week 0, week 10, and 6 months follow up

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Week 0, week 10 and 6 months follow-up

Data from ClinicalTrials.gov

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