Psychological Treatment for Intrusive Thoughts

Overseen By Sara Velazquez, B.S.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Psychotropic medications

Disqualifiers: Psychotic disorder, Bipolar, ADHD, others

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

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how psychological treatments can assist individuals with repetitive negative thinking (RNT), such as intrusive thoughts, worries, and ruminations. It seeks to determine if specific therapies, namely Emotion Regulation Therapy - Attention Regulation (AR-ERT) and Supportive Psychotherapy (SPT), can help individuals manage these thoughts and enhance their focus. The trial is recruiting individuals in Massachusetts who primarily struggle with these thoughts and seek help to manage them. Participants must have internet access and be comfortable using a computer for tasks. As an unphased trial, this study provides a unique opportunity to explore innovative therapies that could significantly enhance mental well-being.

Will I have to stop taking my current medications?

The trial requires that participants have a stable dose of psychotropic medications, so if your medication dose is unstable or you recently stopped taking them, you may need to adjust before joining.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Emotion Regulation Therapy - Attention Regulation (AR-ERT) has been tested for safety in people with anxiety disorders, and results suggest it is generally well-tolerated. One study on a shorter version of this therapy, involving a diverse group of young adults, found no major safety concerns. Participants handled the therapy well, indicating it might be safe for those with repetitive negative thoughts.

Supportive Psychotherapy (SPT) is another treatment often used for mental health issues like anxiety and depression. It focuses on providing emotional support and has been widely used without significant safety issues. Studies have shown it helps people manage unwanted, intrusive thoughts without causing harm.

Both AR-ERT and SPT are considered safe options based on existing research. However, discussing any personal concerns with the trial staff before joining the study is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for repetitive negative thinking because they offer unique approaches compared to traditional cognitive-behavioral therapy (CBT) and medication options like SSRIs. Emotion Regulation Therapy - Attention Regulation (AR-ERT) focuses on improving how individuals manage their attention and emotional responses, potentially leading to more effective control over intrusive thoughts. Meanwhile, Supportive Psychotherapy (SPT) provides a comforting space that emphasizes emotional support, which may benefit those who haven't found success with other therapies. These treatments aim to provide alternative pathways for managing negative thought patterns, offering hope for individuals seeking new solutions.

What evidence suggests that this trial's treatments could be effective for repetitive negative thinking?

Research shows that Emotion Regulation Therapy - Attention Regulation (AR-ERT), one of the treatments in this trial, can help manage repetitive negative thoughts. Studies indicate that improving emotional regulation often leads to better outcomes in treating conditions like depression and anxiety. Those who manage their emotions well typically experience more positive feelings and fewer negative ones.

Supportive Psychotherapy (SPT), another treatment option in this trial, has also been found to help with unwanted and repetitive negative thoughts. Older studies and clinical guidelines suggest that SPT effectively creates a supportive environment for managing these thoughts. Both treatments in this trial show promise in helping individuals shift their focus away from negative thinking patterns. ^{6 7 8 9 10}

Who Is on the Research Team?

Ryan J Jacoby, Ph.D.

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 in Massachusetts with repetitive negative thinking due to OCD, GAD, or MDD. Participants must be fluent in English, right-handed, have internet access and a device with a camera and microphone. They should not be currently receiving psychotherapy or have unstable psychotropic medication use.

Inclusion Criteria

I am seeking treatment mainly because I can't stop worrying or thinking negatively.

I can use a computer and do tasks that require quick responses.

Access to a device with an internet connection, camera, and microphone (e.g., computer, smart phone, tablet)

Exclusion Criteria

My ADHD affects my ability to focus on tasks.

You have been diagnosed with a severe mental illness like schizophrenia or bipolar disorder in the past.

I am currently in psychotherapy or plan to start during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either Emotion Regulation Therapy-Attention Regulation (AR-ERT) or Supportive Psychotherapy (SPT) over 8 weeks

8 weeks

8 visits (virtual), some assessments in-person

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Emotion Regulation Therapy - Attention Regulation (AR-ERT)
• Supportive Psychotherapy (SPT)

Trial Overview

The study tests if psychological treatments can improve attention control among those who struggle to stop unwanted thoughts related to OCD, GAD, and MDD. It compares Emotion Regulation Therapy focused on Attention Regulation (AR-ERT) against Supportive Psychotherapy (SPT).

How Is the Trial Designed?

Group I: Emotion Regulation Therapy - Attention Regulation (AR-ERT) Experimental Treatment 1 Intervention

Individuals with repetitive negative thinking receiving Emotion Regulation Therapy - Attention Regulation.

Group II: Supportive Psychotherapy (SPT) Active Control 1 Intervention

Individuals with repetitive negative thinking receiving Supportive Psychotherapy.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10896752/

A Study of Emotion Regulation Difficulties, Repetitive ...

Therefore, the present study aimed to compare emotion regulation difficulties, repetitive negative thinking, and experiential avoidance between people who ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7611874/

A meta-analysis of emotional regulation outcomes in ...

This meta-analysis examined whether improvements in ER skills were associated with psychological treatment outcomes for depression and/or anxiety in youth.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2211364924000794

Associations between emotion regulation, symptom ...

Results showed that higher-than-usual self-perceived ER effectiveness was associated with higher current positive affect and lower current negative affect and ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2589979124000234

A systematic review of interventions aimed at improving ...

The aim of this review was to map the landscape of interventions targeting emotional regulation difficulties and identify their effectiveness and the ...

5.

cambridge.org

cambridge.org/core/journals/psychological-medicine/article/efficacy-of-cognitive-behavioral-therapy-in-treating-repetitive-negative-thinking-rumination-and-worry-a-transdiagnostic-metaanalysis/64501ADD80C860C7E253F625BB7D115F

Efficacy of cognitive behavioral therapy in treating ...

Efficacy of cognitive behavioral therapy in treating repetitive negative thinking, rumination, and worry – a transdiagnostic meta-analysis ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4973631/

Emotion Regulation Therapy for Generalized Anxiety Disorder

ERT is a mechanism-targeted intervention focusing on patterns of motivational dysfunction while cultivating emotion regulation skills.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7486678/

A Pilot Study of Emotion Regulation Therapy for Generalized ...

The aim of this pilot study was to examine the effectiveness of a briefer 16-session version of ERT in a racially and ethnically diverse sample of young adults.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0022395624002310

Interventions targeting emotion regulation: A systematic ...

Our goal was to investigate the psychotherapeutic interventions used to address ED and gauge their effectiveness, safety, and potential mechanisms across ...

9.

researchgate.net

researchgate.net/publication/313114137_Emotion_Regulation_Therapy_A_Mechanism-Targeted_Treatment_for_Disorders_of_Distress

Emotion Regulation Therapy: A Mechanism-Targeted ...

Despite the success of cognitive behavioral therapies for emotional disorders, a sizable subgroup of patients with distress disorders fail to evidence adequate ...

10.

nimh.nih.gov

nimh.nih.gov/health/publications/obsessive-compulsive-disorder-when-unwanted-thoughts-or-repetitive-behaviors-take-over

When Unwanted Thoughts or Repetitive Behaviors Take Over

Obsessions are repeated thoughts, urges, or mental images that are intrusive, unwanted, and make most people anxious. Common obsessions include: Fear of germs ...