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

Trial Summary

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 data supports the effectiveness of the treatment Cognitive Behavioural Skills Training for Anxiety Disorders?

Research shows that using skills from Cognitive Behavioural Therapy (CBT) can help reduce symptoms of anxiety and depression. Studies have found that learning and applying CBT skills, like changing negative thought patterns and increasing positive activities, can lead to better mental health outcomes. ^{1 2 3 4 5}

Is Cognitive Behavioural Therapy (CBT) safe for humans?

Cognitive Behavioural Therapy (CBT) is generally considered safe for humans, with adverse events being rare and often linked to improper practice by therapists. When done correctly, the rate of adverse events is as low as or lower than using a placebo. ^{1 6 7 8 9}

How is Cognitive Behavioural Skills Training different from other treatments for anxiety disorders?

Cognitive Behavioural Skills Training, also known as Cognitive Behavioural Therapy (CBT), is unique because it can be delivered over the internet, making it more accessible to people who face barriers to traditional in-person therapy. This approach allows individuals to receive treatment from the comfort of their own home, which can be particularly beneficial for those with anxiety disorders. ^{6 10 11 12 13}

What is the purpose of this trial?

Anxiety disorders usually start in childhood and adolescence and are associated with social and occupational difficulties in adulthood. Children who have a parent with an anxiety disorder and who find new situations distressing and avoid them are at an increased risk for developing an anxiety disorder. Research suggests that anti-anxiety parenting can help children grow up courageous and calm. It is, however, difficult to parent in an anti-anxiety way when the parent has an anxiety disorder himself or herself. This research study will test the efficacy of a new program designed to prevent the onset or persistence of anxiety disorders in children at risk for anxiety disorders. The investigators will first help parents learn skills to cope with their own anxiety and then coach them to share these skills with their children and parent in an anti-anxiety way. The goal is to intervene early enough in the children's lives so that they can be free of anxiety disorders and lead happy, healthy and productive lives in adulthood.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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) 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]

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]

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]

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]

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]

References

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

The relationship between posttherapeutic Cognitive Behavior Therapy skills usage and follow-up outcomes of internet-delivered Cognitive Behavior Therapy. [2023]

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

Development and validation of the cognitive-behavioral therapy skills questionnaire. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Outcome of cognitive-behavioural therapy in training practice with anxiety disorder patients. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

5. Netherlands 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. [2020]

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

Training and Clinical Impact of Cognitive Behaviour Therapy Workshops in a Teaching Hospital in North India. [2023]

7. Japan pubmed.ncbi.nlm.nih.gov

[Adverse Events and Precautions Regarding Cognitive Behavioral Therapy]. [2018]

8. England 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. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy for anxiety disorders in children and adolescents. [2021]

10. Netherlands 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. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Neural predictors of cognitive-behavior therapy outcome in anxiety-related disorders: a meta-analysis of task-based fMRI studies. [2023]

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

Intensive cognitive therapy for PTSD: a feasibility study. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Metacognitive therapy versus cognitive-behavioural therapy in adults with generalised anxiety disorder. [2022]