Digital cognitive behavioural therapy for anxiety

Efficacy of DigitaL cognitive behavioural Therapy to reduce symptoms of anxiety in adults with generalised Anxiety disorder: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12765810

Enrollment

242

Registered

2019-01-11

Start date

2019-06-01

Completion date

Unknown

Last updated

2020-11-02

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

Conditions

Generalised anxiety disorder Mental and Behavioural Disorders Generalized anxiety disorder

Interventions

Current interventions as of 01/05/2019: The intervention involves interactive and tailored delivery of digital CBT (cognitive behavioural therapy) for worry and anxiety via a smartphon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria as of 18/09/2019: 1. Aged 18+ years. 2. A score of 10 or higher on the Generalised Anxiety Disorder questionnaire (GAD-7) indicating at least moderate GAD symptom severity. 3. Screen positive for a GAD diagnosis on a digital version of the MINI International Neuropsychiatric Interview (MINI) version 7 for DSM-5. 4. Must be either not on psychotropic medication or on a stable dose for at least 4 weeks. 5. Must not be currently receiving or have previously received CBT for anxiety in the last 12 months. Previous participant inclusion criteria: 1. Aged 18+ years 2. A score of 10 or higher on the Generalised Anxiety Disorder questionnaire (GAD-7) indicating at least moderate GAD symptom severity 3. Screen positive for a GAD diagnosis on a digital version of the MINI International Neuropsychiatric Interview (MINI) version 7 for DSM-5 4. Must be either not on psychotropic medication or on a stable dose for at least 4 weeks

Exclusion criteria

Exclusion criteria: 1. Past or present seizure disorder or a clinically significant head trauma (e.g. brain damage) 2. Substance use disorder 3. Serious physical health concerns necessitating surgery or with prognosis < 6 months 4. Current bipolar disorder, psychosis, or schizophrenia 5. Severe cognitive impairment that does not allow participants to consent or follow treatment instructions 6. Pregnancy

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 08/08/2019: Severity of anxiety symptoms will be measured using the 7-item Generalised Anxiety Disorder questionnaire (GAD-7) (Spitzer et al., 2006) at baseline, mid-intervention (3 weeks from randomisation), post-intervention (6 weeks from randomisation; primary endpoint), and follow-up (10 weeks from randomisation). Previous primary outcome measure: Severity of anxiety symptoms will be measured using the 7-item Generalised Anxiety Disorder questionnaire (GAD-7) (Spitzer et al., 2006) at baseline, mid-intervention (3 weeks from randomisation), post-intervention (6 weeks from randomisation; primary endpoint), and follow-up (18 weeks from randomisation).	—

Measure

Time frame

Current primary outcome measure as of 08/08/2019: Severity of anxiety symptoms will be measured using the 7-item Generalised Anxiety Disorder questionnaire (GAD-7) (Spitzer et al., 2006) at baseline, mid-intervention (3 weeks from randomisation), post-intervention (6 weeks from randomisation; primary endpoint), and follow-up (10 weeks from randomisation). Previous primary outcome measure: Severity of anxiety symptoms will be measured using the 7-item Generalised Anxiety Disorder questionnaire (GAD-7) (Spitzer et al., 2006) at baseline, mid-intervention (3 weeks from randomisation), post-intervention (6 weeks from randomisation; primary endpoint), and follow-up (18 weeks from randomisation).

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Secondary

Measure	Time frame
Current secondary outcome measures as of 08/08/2019: 1. Worry, measured using the Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger, & Borkovec, 1990) at baseline, mid-intervention (3 weeks from randomisation), post-intervention (6 weeks from randomisation), and follow-up (10 weeks from randomisation). 2. Depression symptom severity, assessed using the 9-item Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001) at baseline, mid-intervention (3 weeks from randomisation), post-intervention (6 weeks from randomisation), and follow-up (10 weeks from randomisation). 3. Insomnia symptom severity, assessed using the Sleep Condition Indicator (SCI; Espie et al., 2014) at baseline, mid-intervention (3 weeks from randomisation), post-intervention (6 weeks from randomisation), and follow-up (10 weeks from randomisation). 4. Wellbeing, assessed using the 14-item Warwick-Edinburgh Mental Well-being Scale (WEMWBS; Tennant et al., 2007) at baseline, mid-intervention (3 weeks from randomisation), post-intervention (6 weeks from randomisation), and follow-up (10 weeks from randomisation). 5. Quality of life, assessed using the Patient-Generated Index (PGI; (Ruta, Garratt, Leng, Russell, & MacDonald, 1994) at baseline, mid-intervention (3 weeks from randomisation), post-intervention (6 weeks from randomisation), and follow-up (10 weeks from randomisation). Other outcome measures: 1. Treatment credibility and expectancy, assessed using the 6-item Credibility/Expectancy Questionnaire (Devilly & Borkovec, 2000) administered at baseline only. 2. Treatment satisfaction, assessed in participants randomised to the intervention arm by the following questions administered at post-intervention: 1) “How would you rate your overall satisfaction with the programme?” (ranging from 0 (totally dissatisfied) to 10 (totally satisfied)), 2) “Wha	—

Measure

Time frame

Current secondary outcome measures as of 08/08/2019: 1. Worry, measured using the Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger, & Borkovec, 1990) at baseline, mid-intervention (3 weeks from randomisation), post-intervention (6 weeks from randomisation), and follow-up (10 weeks from randomisation). 2. Depression symptom severity, assessed using the 9-item Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001) at baseline, mid-intervention (3 weeks from randomisation), post-intervention (6 weeks from randomisation), and follow-up (10 weeks from randomisation). 3. Insomnia symptom severity, assessed using the Sleep Condition Indicator (SCI; Espie et al., 2014) at baseline, mid-intervention (3 weeks from randomisation), post-intervention (6 weeks from randomisation), and follow-up (10 weeks from randomisation). 4. Wellbeing, assessed using the 14-item Warwick-Edinburgh Mental Well-being Scale (WEMWBS; Tennant et al., 2007) at baseline, mid-intervention (3 weeks from randomisation), post-intervention (6 weeks from randomisation), and follow-up (10 weeks from randomisation). 5. Quality of life, assessed using the Patient-Generated Index (PGI; (Ruta, Garratt, Leng, Russell, & MacDonald, 1994) at baseline, mid-intervention (3 weeks from randomisation), post-intervention (6 weeks from randomisation), and follow-up (10 weeks from randomisation). Other outcome measures: 1. Treatment credibility and expectancy, assessed using the 6-item Credibility/Expectancy Questionnaire (Devilly & Borkovec, 2000) administered at baseline only. 2. Treatment satisfaction, assessed in participants randomised to the intervention arm by the following questions administered at post-intervention: 1) “How would you rate your overall satisfaction with the programme?” (ranging from 0 (totally dissatisfied) to 10 (totally satisfied)), 2) “Wha

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Countries

United Kingdom, United States of America

Contacts

Public ContactChris Miller

anxiety@ndcn.ox.ac.uk+447305234684

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026