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

Trial Summary

What is the purpose of this trial?

Randomized controlled trial of an exposure-based behavioral treatment (CBT) in adults with functional dyspepsia who meet criteria for avoidant/restrictive food intake disorder (ARFID) with weight loss.

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 data supports the idea that Cognitive Behavioral Therapy for ARFID is an effective treatment?

The available research does not provide specific data on the effectiveness of Cognitive Behavioral Therapy (CBT) for ARFID. Instead, it focuses on the use of CBT and Acceptance and Commitment Therapy (ACT) for depression. These studies suggest that both CBT and ACT are effective for treating depression, with some evidence indicating that CBT might outperform ACT. However, there is no direct evidence in the provided research about CBT's effectiveness for ARFID specifically. ^{1 2 3 4 5}

What safety data exists for Cognitive Behavioral Therapy and related therapies?

The provided research does not directly address safety data for Cognitive Behavioral Therapy (CBT) or its related therapies like MBCT, DBT, or ACT. However, it does suggest that these therapies are being studied for their feasibility, acceptability, and clinical outcomes in various conditions such as borderline personality disorder, generalized anxiety disorder, and PTSD. This implies that these therapies are generally considered safe enough to be tested in clinical settings, but specific safety data is not detailed in the abstracts provided. ^{6 7 8 9 10}

Is Cognitive Behavioral Therapy a promising treatment for ARFID?

Yes, Cognitive Behavioral Therapy (CBT) is a promising treatment. It includes approaches like Acceptance and Commitment Therapy (ACT), which has shown effectiveness in improving mental health conditions like anxiety and depression. These therapies help people manage their thoughts and emotions better, leading to improved quality of life. ^{1 8 10 11 12}

Research Team

Helen Burton Murray, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. United States 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. [2018]

2. England pubmed.ncbi.nlm.nih.gov

One year follow-up and mediation in cognitive behavioral therapy and acceptance and commitment therapy for adult depression. [2021]

3. United States 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. [2021]

4. Switzerland 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. [2019]

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

Clinical errors in cognitive-behavior therapy. [2018]

6. England pubmed.ncbi.nlm.nih.gov

A feasibility study of mindfulness-based cognitive therapy for individuals with borderline personality disorder. [2018]

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

A pilot study of group mindfulness-based cognitive therapy (MBCT) for combat veterans with posttraumatic stress disorder (PTSD). [2022]

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

Efficacy of an acceptance-based group behavioral therapy for generalized anxiety disorder. [2022]

9. Hungary pubmed.ncbi.nlm.nih.gov

[Borderline personality disorder and non-suicidal self-injury: the role of mindfulness training in risk reduction]. [2023]

10. Netherlands 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. [2021]

11. India 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. [2022]

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

An Acceptance-Based Behavioral Therapy for Individuals with Generalized Anxiety Disorder. [2020]