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Completed

NCT Number: NCT04313439

Targeting Taboo Thoughts In Obsessive-Compulsive Disorder

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.

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Obsessive Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, 17177, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Personal Significance Scale (PSS)

    Time frame: 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.

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

    Time frame: 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.

  4. Clinical Global Impression (CGI)

    Time frame: 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.

  5. Work and social adjustment scale (WSAS)

    Time frame: 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.

  6. Thought Action Fusion Scale (TAFS)

    Time frame: 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.

  7. Penn State Worry Questionnaire (PSWQ)

    Time frame: 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.

  8. Meta-Cognitive Questionnaire (Negative metacognitions subscale; MCQ-NC)

    Time frame: 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.

  9. Patient Satisfaction Questionnaire (PSQ)

    Time frame: Week 10

    Satisfaction of treatment at week 10. Qualitative questions.

  10. Adverse events (AE)

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

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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2020
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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