Cognitive behavioural therapy to reduce anxiety and depression in atrial fibrillation

Cognitive Behavioural Therapy to reduce anxiety and depression in patients with Atrial Fibrillation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN33129243

Enrollment

128

Registered

2017-05-25

Start date

2017-09-01

Completion date

Unknown

Last updated

2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety and depression in people with atrial fibrillation Mental and Behavioural Disorders

Interventions

Participants will be recruited from GP practices and specialist AF clinics. The potential participant will be screened for eligibility using the GAD-7, PHQ-9, and AFSS questionnaires. Eligible patient

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and over 2. Diagnosed with atrial fibrillation (AF) within the last 12 months 3. Defined as ‘case’ (score of =8 on the GAD-7 and =10 on the PHQ-9)

Exclusion criteria

Exclusion criteria: 1. Diagnosed with AF for longer than 12 month 2. Terminal illness 3. Cognitive impairment which prevents them from being able to give informed consent 4. Unable to speak and/or read English.

Design outcomes

Primary

Measure	Time frame
1. Anxiety is measured by using the Generalised Anxiety Disorder -7 Questionnaire (GAD -7) at screening, beginning of each therapy session (CBT arm only) 6 and 12 month follow up 2. Depression is measured by using the Patient Health Questionnaire –9 (PHQ–9) at screening, beginning of each therapy session (CBT arm only) 6 and 12 month follow up	—

Secondary

Measure	Time frame
1. Subjective ratings of AF-related symptoms and AF disease burden will be captured using the Atrial Fibrillation Severity Scale (AFSS) at screening, baseline, beginning of each therapy session (CBT arm only) 6 and 12 month follow up 2. Health outcome is measured by using the EuroQoL-5D-5L Questionnaire (EQ-5D-5L) at baseline, 6 and 12 month follow-up 3. Patient satisfaction will be measured using the Patient satisfaction Survey at 6 and 12 months 4. Health-related quality of life (HRQoL) will be measured using one disease specific, the Atrial Fibrillation Effects on QualiTy –of-Life (AFeQT) questionnaire at baseline, 6 and 12 month follow-up 5. The physical and mental HRQoL will be measured using the Short Form- 12 health questionnaire at baseline, 6 and 12 month follow-up 6. Functional impairment which attributes to the anxiety and/or depression will be measured using the Work and Social Adjustment Scale (WSAS) at baseline, 6 and 12 month follow-up	—

Measure

Time frame

1. Subjective ratings of AF-related symptoms and AF disease burden will be captured using the Atrial Fibrillation Severity Scale (AFSS) at screening, baseline, beginning of each therapy session (CBT arm only) 6 and 12 month follow up 2. Health outcome is measured by using the EuroQoL-5D-5L Questionnaire (EQ-5D-5L) at baseline, 6 and 12 month follow-up 3. Patient satisfaction will be measured using the Patient satisfaction Survey at 6 and 12 months 4. Health-related quality of life (HRQoL) will be measured using one disease specific, the Atrial Fibrillation Effects on QualiTy –of-Life (AFeQT) questionnaire at baseline, 6 and 12 month follow-up 5. The physical and mental HRQoL will be measured using the Short Form- 12 health questionnaire at baseline, 6 and 12 month follow-up 6. Functional impairment which attributes to the anxiety and/or depression will be measured using the Work and Social Adjustment Scale (WSAS) at baseline, 6 and 12 month follow-up

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026