Panic Disorder Mental and Behavioural Disorders Panic Disorder
Conditions
Interventions
The main research is a feasibility study to determine whether a full RCT to establish the effectiveness and cost-effectiveness of brief cognitive therapy and an existing cognitive behavioural treatmen
Sponsors
University of Reading
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 14/09/2021: 1. Aged 11-18 years at assessment 2. A DSM-5 diagnosis of panic disorder that has been identified as the primary or secondary presenting disorder 3. At least one panic attack in the month prior to assessment 4. No psychotropic medication use or alternatively, willingness to be withdrawn from medication before the start of the trial under the supervision of the young person’s GP (a minimum 6-week drug-free period for SSRIs and a 2-day drug free period for benzodiazepines will be required before the young person can start trial treatment) and agreement not to start medication during the trial 5. If the young person has a co-morbid medical condition (such as asthma, epilepsy or cardiovascular disease), the young person’s GP must have been consulted and given the opinion that this will not interfere with treatment delivery 6. Willingness to engage in the treatment 7. Willingness to accept random allocation _____ Previous inclusion criteria as of 24/08/2021: 1. Aged 11 - 17.5 years at assessment 2. A DSM-5 diagnosis of panic disorder that has been identified as the primary or secondary presenting disorder 3. At least one panic attack in the month prior to assessment 4. No psychotropic medication use or alternatively, willingness to be withdrawn from medication before the start of the trial under the supervision of the young person’s GP (a minimum 6-week drug-free period for SSRIs and a 2-day drug free period for benzodiazepines will be required before the young person can start trial treatment) and agreement not to start medication during the trial 5. If the young person has a co-morbid medical condition (such as asthma, epilepsy or cardiovascular disease), the young person’s GP must have been consulted and given the opinion that this will not interfere with treatment delivery 6. Willingness to engage in the treatment 7. Willingness to accept random allocation _____ Previous inclusion criteria: 1. Aged 11 - 17.5 years at assessment 2. A DSM-5 diagnosis of panic disorder that has been identified as the primary presenting disorder 3. At least one panic attack in the month prior to assessment 4. No psychotropic medication use or alternatively, willingness to be withdrawn from medication before the start of the trial under the supervision of the young person’s GP (a minimum 6-week drug-free period for SSRIs and a 2-day drug free period for benzodiazepines will be required before the young person can start trial treatment) and agreement not to start medication during the trial 5. If the young person has a co-morbid medical condition (such as asthma, epilepsy or cardiovascular disease), the young person’s GP must have been consulted and given the opinion that this will not interfere with treatment delivery 6. Willingness to engage in the treatment 7. Willingness to accept random allocation
Exclusion criteria
Exclusion criteria: 1. A current primary disorder other than panic disorder (such as another anxiety disorder or major depressive disorder (MDD)), identified through a diagnostic assessment at baseline 2. Co-morbid conditions that are likely to interfere with treatment delivery; such as an established autistic spectrum disorder, learning disabilities, suicidal intent, or recurrent or potentially life-limiting self-harm (i.e. current frequency of at least once per week or self-harm that requires medical attention) 3. Having been identified by social services as currently ‘at risk’ due to, for example, child protection concerns 4. Currently receiving a psychological intervention or have received previous treatment with cognitive therapy or graded exposure therapy for panic disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of a definitive RCT on the basis of acceptability of the treatments and trial procedures, recruitment rates, rate of treatment drop out, and retention to research assessments 12-weeks after the start of treatment. The specific outcome measures are: 1. Young person's panic disorder symptoms and interference in daily life measured using Panic Disorder Severity Scale for Children and Adolescents and the Child Anxiety Interference Scale 2. Young person's diagnostic status, quality of life and health resource use measured using the Anxiety Disorders Interview Schedule (ADIS-C/P), The Clinical Global Impression Scale - Improvement, Outcome Rating Scale, EQ-5D (5L), Child Health Utility 9D and Client Services Receipt Inventory (CSRI) 3. Acceptability of the treatments and trial procedures measured using the Experience of Service Questionnaire and qualitative interviews 4. Rate of recruitment, drop-out, and retention to post-treatment and 3-month follow-up assessments using patient records 5. Therapist treatment adherence measured using the Therapy Content Checklist 6. Treatment credibility measured using the Treatment Credibility and Expectation of Improvement Questionnaire 7. Adverse events measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| At post-treatment and 3-month follow up: 1. Bodily sensations measured using the Body Sensations Questionnaire 2. Panic cognitions measured using the Agoraphobia Cognitions Questionnaire 3. Safety behaviours measured using Safety Behaviours Questionnaire 4. Avoidance measured using the Mobility Inventory | — |
Countries
England, United Kingdom
Outcome results
None listed