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Targeting Taboo Thoughts In Obsessive-Compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Online cognitive therapy (I-CT)

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Obsessions, Cognitive therapy, Internet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Karolinska Institutet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Online Cognitive Therapy (I-CT)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

Patient Satisfaction Questionnaire (PSQ)

Satisfaction of treatment at week 10. Qualitative questions.

Adverse events (AE)

Number of adverse events every week during treatment and post treatment week 10.

Full Information

NCT ID

NCT04313439

First Posted

March 12, 2020

Last Updated

August 16, 2021

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT04313439

Brief Title

Targeting Taboo Thoughts In Obsessive-Compulsive Disorder

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

March 26, 2020 (Actual)

Primary Completion Date

February 15, 2021 (Actual)

Study Completion Date

August 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive-Compulsive Disorder

Keywords

Obsessions, Cognitive therapy, Internet

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Online Cognitive Therapy (I-CT)

Intervention Type

Other

Intervention Name(s)

Online cognitive therapy (I-CT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

The clinician rated Yale Brown Obsessive Compulsive Scale (Y-BOCS)

Description

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 Outcome Measure Information:

Title

The self-rated Yale Brown Obsessive Compulsive Scale (Y-BOCS)

Description

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

Title

Personal Significance Scale (PSS)

Description

Time Frame

Weeks 0 to 10 through treatment and 6 months follow-up

Title

Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)

Description

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