Cognitive Behavioural Skills Training for Anxiety Disorders

(COACH Trial)

Overseen By Jill Cumby, RN

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Schizophrenia, Autism, Intellectual disability, 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: Unknown

Duration: 1 year

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to help parents with anxiety disorders manage their own anxiety and teach these skills to their children. The main goal is to prevent anxiety disorders in children who might be at risk, particularly those with a parent who has an anxiety disorder. It is ideal for parents currently dealing with anxiety and who have children aged two to eight. By participating, parents can learn ways to help their children grow up calm and confident. As an unphased trial, this study offers parents a unique opportunity to gain valuable skills that can positively impact their family's well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this program is safe for children and parents?

Research has shown that cognitive behavioral skills training is generally easy for people to handle. Studies highlight it as a leading treatment for anxiety and stress-related issues, making it widely trusted and used. This treatment helps individuals manage anxiety by changing negative thoughts and behaviors.

Safety data on cognitive behavioral skills training indicate few, if any, negative effects. For most people, it is safe and effective. Research reviews have shown that about 60% of children improve with similar methods, without major side effects.

In summary, cognitive behavioral skills training is a well-accepted approach with a strong safety record, designed to help people manage anxiety safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cognitive behavioural skills training for anxiety disorders because it offers a hands-on, skills-based approach that empowers individuals to manage their anxiety actively. Unlike standard treatments like medication or traditional talk therapy, this training emphasizes practical strategies that individuals can use in their daily lives to reduce anxiety symptoms. It focuses on teaching specific techniques to modify thought patterns and behaviors, potentially offering a more personalized and sustainable way to mitigate anxiety compared to other methods.

What evidence suggests that cognitive behavioural skills training is effective for preventing anxiety disorders in children?

Research has shown that cognitive behavioral therapy (CBT) effectively treats anxiety disorders. Studies have found that CBT can greatly reduce anxiety symptoms. In this trial, participants will receive cognitive behavioral skills training, a form of CBT, which has been linked to noticeable decreases in both anxiety and depression symptoms over time for people with moderate to severe anxiety. While not everyone benefits from CBT, about half of those with generalized anxiety disorder see improvement. Overall, CBT has demonstrated better results compared to usual treatment methods, which serve as the control condition in this trial. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for parents with an anxiety disorder who have at least one child aged 2-8 years. They must be able to give informed consent and speak English well enough to participate in the training.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Parents learn skills to cope with their own anxiety and are coached to share these skills with their children

1 year

Follow-up

Participants are monitored for anxiety disorders and functioning over time

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive behavioural skills training

Trial Overview

The study tests a new program aimed at preventing anxiety disorders in children at risk by first teaching coping skills to parents, then coaching them on how to pass these skills onto their children.

How Is the Trial Designed?

Group I: Cognitive behavioural skills training Experimental Treatment 1 Intervention

Group II: No intervention Active Control 1 Intervention

Participants in the control group will receive their usual clinical care and will not be discouraged from seeking any intervention.

Cognitive behavioural skills training is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cognitive Behavioural Therapy (CBT) for:

• Anxiety disorders
• Depression
• Post-traumatic stress disorder (PTSD)

Approved in United States as Cognitive Behavioural Therapy (CBT) for:

• Anxiety disorders
• Depression
• Substance abuse
• Eating disorders

Approved in Canada as Cognitive Behavioural Therapy (CBT) for:

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

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Barbara Pavlova

Lead Sponsor

Trials

1

Recruited

90+

Published Research Related to This Trial

An internet-delivered cognitive behavioral therapy (CBT) intervention called Calming Anxiety was tested on 137 Irish university students, showing that both the treatment and waiting list groups experienced significant reductions in anxiety symptoms after the intervention, but no significant difference between the two groups was found.

While the CBT intervention did not show a clear advantage over the waiting list in reducing anxiety, it did lead to significant improvements in depression and social functioning, indicating potential benefits of the treatment in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an internet-delivered intervention for generalized anxiety disorder in routine care: A randomised controlled trial in a student population. Richards, D., Timulak, L., Rashleigh, C., et al.[2022]

In a feasibility study involving 14 patients, an intensive version of Cognitive Therapy for PTSD (CT-PTSD) was well tolerated, with 85.7% of participants no longer meeting the criteria for PTSD after treatment.

Intensive CT-PTSD not only achieved similar outcomes to traditional weekly therapy but also resulted in faster symptom improvement and greater reductions in depression, suggesting it could be a promising alternative for treating PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive cognitive therapy for PTSD: a feasibility study. Ehlers, A., Clark, DM., Hackmann, A., et al.[2022]

Cognitive Behavioral Therapy (CBT) is likely more effective than waiting lists or no treatment for childhood anxiety disorders, with a remission rate of 49.4% compared to 17.8% for waitlist participants, based on a review of 87 studies involving 5964 participants.

There is limited evidence to suggest that CBT is superior to treatment as usual or alternative treatments, indicating that while CBT is beneficial, its effectiveness compared to other established treatments remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy for anxiety disorders in children and adolescents. James, AC., Reardon, T., Soler, A., et al.[2021]

A systematic review and meta-analysis of 17 studies involving 442 participants found that specific brain regions related to salience and interoception are strong predictors of positive outcomes from cognitive-behavior therapy (CBT) for anxiety-related disorders.

Identifying these neural predictors could help in developing personalized treatment approaches for individuals with anxiety disorders, enhancing the effectiveness of CBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural predictors of cognitive-behavior therapy outcome in anxiety-related disorders: a meta-analysis of task-based fMRI studies. Picó-Pérez, M., Fullana, MA., Albajes-Eizagirre, A., et al.[2023]

Over nine years, nine CBT training workshops in a psychiatric center in north India significantly increased the number of patients receiving CBT, demonstrating the effectiveness of these training programs in a resource-limited setting.

Naturalistic outcomes showed that over 90% of patients who completed therapy reported improvement, indicating that the workshops not only trained practitioners but also positively impacted patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training and Clinical Impact of Cognitive Behaviour Therapy Workshops in a Teaching Hospital in North India. Gupta, AK., Sharma, E., Kar, SK., et al.[2023]

Cognitive Behaviour Therapy (CBT) and counselling showed comparable effectiveness in treating moderate to severe depression, with pre-post effect sizes of 1.59 for CBT and 1.55 for counselling, indicating both can be effective options.

Patients receiving counselling attended fewer sessions on average (7.5 sessions) compared to those receiving CBT (8.9 sessions), and counselling was found to be more effective at the two-session mark, suggesting that session length and type of therapy may influence outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comparative effectiveness and efficiency of cognitive behaviour therapy and generic counselling in the treatment of depression: evidence from the 2nd UK National Audit of psychological therapies. Pybis, J., Saxon, D., Hill, A., et al.[2020]

Cognitive-behavioral therapy (CBT) has made significant progress in effectively treating anxiety disorders, particularly panic disorders, showing promising results.

There is potential for expanding cognitive therapy techniques to other anxiety-related conditions like hypochondriasis, obsessional disorders, and specific phobias, although challenges to the existing cognitive theory remain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A critique of cognitive therapy for anxiety disorders. Rachman, S.[2019]

In a study involving 523 outpatients undergoing 12-14 weeks of cognitive therapy (CT), improvements in patients' cognitive therapy skills were linked to reductions in depressive symptoms, suggesting that these skills play a crucial role in treatment efficacy.

The research indicates that while depressive symptoms did not influence the development of cognitive therapy skills, higher skill levels during treatment were associated with better outcomes, highlighting the importance of skill acquisition in managing depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' comprehension and skill usage as a putative mediator of change or an engaged target in cognitive therapy: Preliminary findings. Jarrett, RB., Vittengl, JR., Clark, LA., et al.[2020]

In a study involving 241 participants who underwent 8 weeks of internet-delivered Cognitive Behavior Therapy (iCBT), a direct relationship was found between the frequency of using CBT skills and current levels of anxiety, depression, and functional impairment.

However, the study did not find consistent long-term effects of CBT skills usage on clinical outcomes, suggesting that while using these skills is beneficial in the moment, their role in maintaining improvements after therapy is still unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between posttherapeutic Cognitive Behavior Therapy skills usage and follow-up outcomes of internet-delivered Cognitive Behavior Therapy. Eilert, N., Wogan, R., Adegoke, A., et al.[2023]

The Cognitive-Behavioral Therapy Skills Questionnaire (CBTSQ) was developed and validated through two studies involving 728 participants, demonstrating strong internal consistency and a clear factor structure with two main components: Behavioral Activation and Cognitive Restructuring.

Scores on the CBTSQ increased after treatment, and higher scores in both factors were associated with a reduction in overall psychiatric symptoms and depression, indicating its potential as a useful tool for tracking CBT skill acquisition and treatment progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of the cognitive-behavioral therapy skills questionnaire. Jacob, KL., Christopher, MS., Neuhaus, EC.[2018]

In a study involving 246 patients with generalized anxiety disorder (GAD), metacognitive therapy (MCT) was found to be more effective than cognitive-behavioral therapy (CBT), with a significant mean difference in treatment outcomes and higher recovery rates (65% for MCT vs. 38% for CBT).

Both therapies were assessed at pre-treatment, post-treatment, and a 2-year follow-up, showing that the superior effects of MCT were maintained over time, indicating its potential as a more effective long-term treatment option for GAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metacognitive therapy versus cognitive-behavioural therapy in adults with generalised anxiety disorder. Nordahl, HM., Borkovec, TD., Hagen, R., et al.[2022]

When cognitive behavioral therapy (CBT) is conducted effectively, the rate of adverse events is very low, comparable to or even lower than that of a placebo, indicating its safety and efficacy.

Many adverse events arise from poor-quality CBT due to therapists' insufficient training, highlighting the importance of regular patient assessments and supervision to ensure high standards in therapy delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse Events and Precautions Regarding Cognitive Behavioral Therapy]. Okmaoto, Y., Jinnin, R., Yoshino, A., et al.[2018]

Cognitive-behavioral therapy (CBT) delivered by trainee therapists was effective for patients with anxiety disorders, showing a large pre-post effect size of 1.09, although this was slightly lower than results from controlled studies.

Out of 64 patients who completed the treatment, 61% showed improvement and 52.5% fully recovered, which is comparable to outcomes reported in other studies, despite a higher drop-out rate of 33.3% and longer treatment duration averaging 27.4 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of cognitive-behavioural therapy in training practice with anxiety disorder patients. Bados, A., Balaguer, G., Saldaña, C.[2022]

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