Cognitive Behavioral Therapy for ARFID

Overseen By Blythe Peterson, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Narcotic analgesics

Disqualifiers: Pregnancy, Psychosis, Diabetes, Cancer, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of Cognitive Behavioral Therapy (CBT) for adults struggling with eating due to functional dyspepsia (a chronic stomach issue) and avoidant/restrictive food intake disorder (ARFID). Researchers will divide participants into two groups: one will receive CBT tailored to their condition, while the other will continue with their usual care. The trial aims to determine if CBT can improve eating habits and reduce weight loss. Suitable candidates are adults who have lost at least 5% of their weight since symptom onset and have not previously undergone CBT. As an unphased trial, this study provides a unique opportunity for participants to contribute to understanding how CBT can benefit those with eating difficulties.

Do I have to stop taking my current medications for this trial?

The trial does not specify that you must stop taking your current medications, but you need to be on a stable dose for 30 days if you are on any medication.

What prior data suggests that Cognitive Behavioral Therapy is safe for treating ARFID with functional dyspepsia?

Research has shown that Cognitive Behavioral Therapy (CBT) is generally safe and well-tolerated. CBT, a type of talk therapy, helps individuals manage problems by changing their thoughts and behaviors. Studies have found that CBT effectively addresses many mental health issues, such as anxiety and depression. It avoids medication use, thereby sidestepping drug-related side effects.

Overall, participants in CBT typically experience no major side effects. As a common and well-studied therapy, its safety is well-established. Those considering this trial can feel confident in CBT's safety based on existing research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for ARFID, which often involves nutritional counseling and sometimes medication, Cognitive Behavioral Therapy (CBT) focuses on changing the thoughts and behaviors associated with food intake. Researchers are excited about CBT because it directly addresses the psychological patterns that contribute to food avoidance and restriction, offering a more targeted approach than traditional methods. This therapy empowers individuals by helping them develop healthier eating habits and coping strategies, potentially leading to more sustainable long-term outcomes.

What evidence suggests that Cognitive Behavioral Therapy is effective for ARFID?

Research shows that Cognitive Behavioral Therapy (CBT), which participants in this trial may receive, effectively treats various mental health issues. CBT helps individuals recognize and change negative thoughts that affect their feelings and actions. Studies have found it particularly helpful for mood problems, anxiety, and some eating disorders. For eating disorders, CBT often focuses on changing thoughts and behaviors related to food and body image. These therapy sessions aim to improve symptoms and overall quality of life. Although limited data exists on CBT for ARFID (Avoidant/Restrictive Food Intake Disorder), its success with similar conditions suggests it could be beneficial. ^{1 3 4 6 7}

Who Is on the Research Team?

Helen Burton Murray, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults with functional dyspepsia and ARFID, who've lost weight since the onset of FD. They must be stable enough for outpatient care, have not had CBT for FD or ARFID before, can use a computer with webcam, haven't changed medications recently, speak English fluently, and don’t have certain medical conditions like psychosis or recent surgeries.

Inclusion Criteria

Negative upper endoscopy or upper radiographic GI series to rule out structural/organic cause for FD

Computer/internet webcam access

I have been diagnosed with a type of indigestion that gets worse after eating.

Exclusion Criteria

Inability to provide informed consent

Current enteral or parenteral feeding

Use of narcotic analgesics greater than three days per week

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cognitive behavioral therapy for functional dyspepsia with avoidant restrictive food intake disorder, consisting of eight 1-hour sessions delivered weekly via a secure video platform

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy

Trial Overview

The study tests an exposure-based cognitive behavioral therapy (CBT) specifically designed to treat avoidant/restrictive food intake in individuals suffering from functional dyspepsia. Participants are randomly assigned to receive this treatment to see if it helps improve their condition.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy Experimental Treatment 1 Intervention

Subjects will receive cognitive behavioral therapy for functional dyspepsia with avoidant restrictive food intake disorder.

Group II: Usual Care Active Control 1 Intervention

In the usual care condition, participants will be allowed to continue with treatment they are already receiving at the time of randomization, and we will collect detailed data on the nature of these interventions. Participants will be allowed to pursue non study treatments in this condition.

Cognitive Behavioral Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in United States as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)
• Substance use disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Acceptance and Commitment Therapy (ACT) showed significant improvements in global mental health, depression, cognitive fusion, and values in complex clients treated by both psychologists and non-psychologists in a National Health Service setting.

The positive effects of ACT were partially maintained at a 3-month follow-up, indicating its potential long-term benefits, and outcomes were similar regardless of the therapist's professional background.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Evaluation of Acceptance and Commitment Therapy Delivered by Psychologists and Non-Psychologists in an NHS Community Adult Mental Health Service: a Preliminary Analysis. Richardson, T., Bell, L., Bolderston, H., et al.[2018]

An 8-week mindfulness-based cognitive therapy (MBCT) program is being tested for its effectiveness in improving mindfulness skills and reducing self-harm behaviors in patients with borderline personality disorder (BPD) who engage in non-suicidal self-injury (NSSI).

The study will involve 60 BPD patients and aims to demonstrate that MBCT is more effective than waiting list or supportive therapy in enhancing emotion and impulse control, which are critical for managing BPD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Borderline personality disorder and non-suicidal self-injury: the role of mindfulness training in risk reduction]. Kresznerits, S., Zinner-Gérecz, Á., Perczel-Forintos, D.[2023]

A randomized controlled trial with 82 patients showed that both Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) significantly reduced depressive symptoms and improved quality of life after 12 months, with no significant difference in effectiveness between the two therapies.

Both therapies appear to work by changing dysfunctional attitudes and promoting decentering, while experiential avoidance was specifically linked to treatment effects in ACT, suggesting different mechanisms of action despite similar outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One year follow-up and mediation in cognitive behavioral therapy and acceptance and commitment therapy for adult depression. A-Tjak, JGL., Morina, N., Topper, M., et al.[2021]

Acceptance and Commitment Therapy (ACT) is an effective treatment for Major Depressive Disorder (MDD), utilizing mindfulness and acceptance strategies to enhance psychological flexibility, which is crucial for behavior change.

ACT can be delivered in various formats, including individual, group, or self-help options, and has shown empirical support for its efficacy in improving depression outcomes through its core processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy for Major Depressive Disorder: Insights into a New Generation of Face-to-Face Treatment and Digital Self-Help Approaches. Apolinário-Hagen, J., Drüge, M., Hennemann, S., et al.[2021]

Cognitive-behavioral therapy (CBT) is effective for many disorders, but some patients do not fully benefit due to clinical errors during therapy, such as neglecting detailed functional analysis and inadequate patient engagement in treatment planning.

Awareness of these clinical errors, like focusing too much on beliefs without behavioral tests and not holding patients accountable, can help therapists improve treatment outcomes in CBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical errors in cognitive-behavior therapy. Kim, EH., Hollon, SD., Olatunji, BO.[2018]

Mindfulness-based cognitive therapy adapted for individuals with borderline personality disorder (BPD) was found to be acceptable, with 22 participants completing an 8-week intervention.

While only attentional control showed significant improvement overall, some participants experienced benefits in mindfulness and dissociation, suggesting that further research into MBCT for BPD is warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study of mindfulness-based cognitive therapy for individuals with borderline personality disorder. Sachse, S., Keville, S., Feigenbaum, J.[2018]

In a randomized clinical trial involving 18 women with generalized anxiety disorder (GAD), Acceptance-based behavior therapy (ABBT) significantly reduced the severity of GAD symptoms and improved quality of life compared to a control group that did not receive psychotherapy.

While ABBT led to a decrease in worry severity, this change was not statistically significant when compared to the control group, indicating that while ABBT is effective for symptom relief, its impact on worry may require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of acceptance-based behavior therapy on severity of symptoms, worry and quality of life in women with generalized anxiety disorder. Zargar, F., Asgharnejad Farid, AA., Atef-Vahid, MK., et al.[2021]

In a study involving 92 individuals with generalized anxiety disorder, acceptance-based group behavioral therapy (ABBT) showed a faster improvement in symptoms compared to standard nondirective supportive therapy (NDST) over 10 sessions.

Both therapies led to significant reductions in anxiety symptoms, but ABBT participants experienced quicker changes, particularly in physical health quality of life, indicating its potential effectiveness in treating GAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an acceptance-based group behavioral therapy for generalized anxiety disorder. de Almeida Sampaio, TP., Jorge, RC., Martins, DS., et al.[2022]

Acceptance Based Behavioral Therapy (ABBT) is designed to help individuals with Generalized Anxiety Disorder (GAD) by encouraging acceptance and mindfulness instead of avoidance of painful emotions and thoughts.

ABBT focuses on helping clients engage in meaningful activities that align with their values, which can lead to more effective coping strategies compared to traditional avoidance behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Acceptance-Based Behavioral Therapy for Individuals with Generalized Anxiety Disorder. Hayes-Skelton, SA., Orsillo, SM., Roemer, L.[2020]

Acceptance-based behavior therapy (ABBT) and applied relaxation (AR) were found to have similar effects on patients with generalized anxiety disorder (GAD) in terms of acceptance of internal experiences, engagement in meaningful activities, and quality of life, based on a study involving 18 patients over 12 weeks.

Both therapies were administered alongside routine drug treatments, indicating that ABBT can be considered an effective alternative to the commonly used AR therapy for managing GAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the effectiveness of acceptance-based behavior therapy and applied relaxation on acceptance of internal experiences, engagement in valued actions and quality of life in generalized anxiety disorder. Zargar, F., Farid, AA., Atef-Vahid, MK., et al.[2022]

Mindfulness-based cognitive therapy (MBCT) adapted for combat PTSD showed significant improvement in PTSD symptoms compared to treatment-as-usual, with a notable reduction in avoidance symptoms and PTSD-related negative cognitions.

The study involved 37 participants (20 in the MBCT group and 17 in the TAU group) over an 8-week period, and 75% of MBCT completers demonstrated good compliance and clinically meaningful improvements in their PTSD assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of group mindfulness-based cognitive therapy (MBCT) for combat veterans with posttraumatic stress disorder (PTSD). King, AP., Erickson, TM., Giardino, ND., et al.[2022]

In a randomized controlled trial with 82 patients suffering from major depressive disorder, both Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT) showed high remission rates of 75% and 80%, respectively, indicating both therapies are effective.

There were no significant differences in effectiveness between ACT and CBT, suggesting that ACT is a viable alternative treatment for depression, warranting further research to explore their effects on different patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial in Routine Clinical Practice Comparing Acceptance and Commitment Therapy with Cognitive Behavioral Therapy for the Treatment of Major Depressive Disorder. A-Tjak, JGL., Morina, N., Topper, M., et al.[2019]

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