Aftercare Treatment for Obsessive-Compulsive Disorder

Overseen By Maria Filippou-Frye, MD, MBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Children, Active suicidality

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to provide participants diagnosed with obsessive compulsive disorder (OCD) and completed one of the active study protocols at the Rodriguez Lab, with open/aftercare treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the aftercare treatment for obsessive-compulsive disorder?

Research shows that combining medication with talk therapy, like cognitive-behavioral therapy, can lead to significant improvement in OCD symptoms. Medications that affect serotonin levels, such as SSRIs, are effective for many patients, and adding therapy can enhance these effects. ^{1 2 3 4 5}

Is the aftercare treatment for OCD safe for humans?

Safety data for treatments like psychotherapy and pharmacotherapy for OCD is limited, but some studies suggest that adverse events are not consistently defined or monitored. Pharmacotherapy, including drugs like clomipramine and paroxetine, has been used safely in many patients, though high doses and long treatment durations are sometimes needed. ^{3 6 7 8 9}

How does the aftercare treatment for OCD differ from other treatments?

The aftercare treatment for OCD may involve transcranial direct current stimulation (tDCS), which is a non-invasive method that uses a low electrical current to stimulate specific areas of the brain. This approach is different from traditional OCD treatments like medication or cognitive-behavioral therapy, as it directly targets brain activity without the need for drugs. ^{10 11 12 13 14}

Research Team

Carolyn Rodriguez, MD, PhD

Principal Investigator

Assistant Professor, Stanford University

Eligibility Criteria

This trial is for adults with Obsessive Compulsive Disorder (OCD) who have finished a previous study at the Rodriguez Lab. They must understand the risks and benefits of this study, be able to consent, and speak English. It's not open to anyone under 18 or those currently having thoughts of suicide.

Inclusion Criteria

I understand the risks, benefits, and procedures of the study and can consent.

Ability to speak and understand English

Completed an active study protocol at the Rodriguez Lab at Stanford University

Exclusion Criteria

I am under 18 years old.

Active suicidality

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either pharmacotherapy by a psychiatrist or evidence-based psychotherapy by a trained psychologist

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Treatment Details

Interventions

• Pharmacotherapy
• Psychotherapy

Trial Overview The trial offers ongoing treatment options for OCD through pharmacotherapy (medication) and psychotherapy (counseling). It's designed for patients from prior studies at the Rodriguez Lab to continue receiving care and support.

Participant Groups

Group I: Pharmacotherapy Active Control 1 Intervention

Participants will receive pharmacotherapy by a psychiatrist

Group II: Psychotherapy Active Control 1 Intervention

Participants will receive evidenced based psychotherapy by a trained psychologist

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

This study will analyze adverse events in psychotherapy for youth with OCD by including at least 128 participants aged 8-17, comparing family-based cognitive behavioral therapy (FCBT) and family-based psychoeducation and relaxation training (FPRT).

The mixed methods approach will combine quantitative assessments of adverse events with qualitative interviews to better understand their nature and causes, aiming to improve the safety and effectiveness of psychotherapy for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder: A mixed methods study and analysis plan for the TECTO trial. Pretzmann, L., Christensen, SH., Bryde Christensen, A., et al.[2023]

A systematic review of 115 psychotherapy study protocols revealed that while 77 protocols explicitly addressed harm, there was a lack of standardization in how harm was conceptualized and assessed, particularly regarding adverse events.

The review highlighted that although serious adverse events were defined consistently, the definitions and considerations for adverse events varied widely, suggesting a need for more standardized approaches in clinical research to effectively monitor and report harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. Klatte, R., Strauss, B., Flückiger, C., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

A review of pharmacologic treatments for obsessive-compulsive disorder. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Moving beyond first-line treatment options for OCD. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Current issues in the pharmacologic management of obsessive compulsive disorder. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A 2012 evidence-based algorithm for the pharmacotherapy for obsessive-compulsive disorder. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of obsessive-compulsive disorder and obsessive-compulsive spectrum disorders. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder: A mixed methods study and analysis plan for the TECTO trial. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

[Drug treatment of obsessive-compulsive disorder. With proper drugs and some patience many patients can be helped]. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Acute and long-term treatment and prevention of relapse of obsessive-compulsive disorder with paroxetine. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Comments on: "Transcranial Direct Current Stimulation for Obsessive-Compulsive Disorder: A Systematic Review". [2020]

11. Germany pubmed.ncbi.nlm.nih.gov

Treatment of Clostridium difficile-associated diarrhea and colitis. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Rifaximin Redux: treatment of recurrent Clostridium difficile infections with rifaximin immediately post-vancomycin treatment. [2020]

13. Chile pubmed.ncbi.nlm.nih.gov

[Multidisciplinary approach of Clostridium difficile infection]. [2020]

14. India pubmed.ncbi.nlm.nih.gov

Clostridium difficile infection: clinical spectrum and approach to management. [2022]