Feasibility and preliminary efficacy of digital cognitive behavioural therapy for anxiety

Feasibility and potential efficacy of digital cognitive behavioural therapy to reduce symptoms of anxiety in adults with Generalised Anxiety Disorder: A randomised multiple-baseline single-case study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN89276818

Enrollment

Registered

2018-08-22

Start date

2018-09-03

Completion date

Unknown

Last updated

2020-10-12

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

Conditions

Generalised anxiety disorder (GAD) Mental and Behavioural Disorders Generalised anxiety disorder (GAD)

Interventions

In this study, participants serve as their own control and are randomised to a baseline period of 2, 4, or 6 weeks (i.e., they will wait for either 2, 4, or 6 weeks before receiving access to the inte

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older 2. Able to give informed consent 3. Score of 10 or higher on the 7-item Generalised Anxiety Disorder questionnaire (GAD-7), indicating moderate severity of anxiety 4. Screen positive for GAD diagnosis by a digital version of the MINI International Neuropsychiatric Interview (MINI) version 7 for DSM-5 5. Must be either not on prescription medication for anxiety, depression, or sleep, or on a stable dose for at least 4 weeks

Exclusion criteria

Exclusion criteria: 1. Past or present psychosis, schizophrenia, bipolar disorder, seizure disorder, alcohol use disorder, or substance use disorder 2. Trauma to the head or brain damage 3. Severe cognitive impairment 4. Serious physical health concerns necessitating surgery or with prognosis < 6 months 5. Pregnancy

Design outcomes

Primary

Measure	Time frame
1. Feasibility, assessed by the following: 1.1. Number of participants who start and complete the digital CBT intervention, assessed post-intervention by objective usage data 1.2. Number of digital CBT intervention components completed, assessed post-intervention by objective usage data 1.3. Participant satisfaction with the digital CBT intervention, assessed post-intervention using self-reported qualitative and quantitative questions: 1.3.1. “How would you rate your overall satisfaction with the programme - ranging from 0 (totally dissatisfied) to 10 (totally satisfied)” 1.3.2. “What could be better about this treatment program?” 1.3.3. “What did you like and enjoy about the treatment program?” 1.3.4. “In what ways did the treatment program help you to reduce your anxiety?” 1.3.5. “At any point during the treatment program did you consider stopping using it? When and Why?” 1.3.6. “Was the content of the treatment program specific enough to your needs?” 1.4. Safety, assessed by occurrence of the following post-intervention: 1.4.1. Any adverse events related to the intervention throughout the study period, self-reported throughout the study by participants to the study coordinator in response to open-ended questions asked during any telephone correspondence with participants from consent until the final follow-up assessment 1.4.2. Unwanted symptoms related to the intervention, assessed using the Modified Symptom Checklist at the post-treatment assessment 1.5. Treatment credibility, assessed by the self-reported Credibility/Expectancy Questionnaire near the start of the digital CBT intervention 2. Potential efficacy of the digital CBT intervention to reduce anxiety, assessed by the following: 2.1. Self-report question (On average ov	—

Measure

Time frame

1. Feasibility, assessed by the following: 1.1. Number of participants who start and complete the digital CBT intervention, assessed post-intervention by objective usage data 1.2. Number of digital CBT intervention components completed, assessed post-intervention by objective usage data 1.3. Participant satisfaction with the digital CBT intervention, assessed post-intervention using self-reported qualitative and quantitative questions: 1.3.1. “How would you rate your overall satisfaction with the programme - ranging from 0 (totally dissatisfied) to 10 (totally satisfied)” 1.3.2. “What could be better about this treatment program?” 1.3.3. “What did you like and enjoy about the treatment program?” 1.3.4. “In what ways did the treatment program help you to reduce your anxiety?” 1.3.5. “At any point during the treatment program did you consider stopping using it? When and Why?” 1.3.6. “Was the content of the treatment program specific enough to your needs?” 1.4. Safety, assessed by occurrence of the following post-intervention: 1.4.1. Any adverse events related to the intervention throughout the study period, self-reported throughout the study by participants to the study coordinator in response to open-ended questions asked during any telephone correspondence with participants from consent until the final follow-up assessment 1.4.2. Unwanted symptoms related to the intervention, assessed using the Modified Symptom Checklist at the post-treatment assessment 1.5. Treatment credibility, assessed by the self-reported Credibility/Expectancy Questionnaire near the start of the digital CBT intervention 2. Potential efficacy of the digital CBT intervention to reduce anxiety, assessed by the following: 2.1. Self-report question (On average ov

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Secondary

Measure	Time frame
Potential efficacy of the digital CBT intervention to improve the following outcomes, which are self-reported online at the baseline, post-intervention and at the follow-up: 1. Worry, assessed using the Penn State Worry Questionnaire (PSWQ) 2. Depression symptom severity, assessed using the 9-item Patient Health Questionnaire (PHQ-9), measured at weekly intervals during baseline and treatment periods in addition to the above 3. Sleep difficulty, assessed using the Sleep Condition Indicator (SCI), measured at weekly intervals during baseline and treatment periods in addition to the above 4. Wellbeing, assessed using the 14-item Warwick-Edinburgh Mental Well-being Scale (WEMWBS) 5. Health-related quality of life, assessed using the Patient-Generated Index (PGI) 6. Work productivity and activity, assessed using the Work Productivity and Activity Impairment (WPAI) questionnaire 7. Cognitive behavioural therapy skills acquisition, assessed using the Cognitive Behavioural Therapy Skills Questionnaire (CBTSQ)	—

Measure

Time frame

Potential efficacy of the digital CBT intervention to improve the following outcomes, which are self-reported online at the baseline, post-intervention and at the follow-up: 1. Worry, assessed using the Penn State Worry Questionnaire (PSWQ) 2. Depression symptom severity, assessed using the 9-item Patient Health Questionnaire (PHQ-9), measured at weekly intervals during baseline and treatment periods in addition to the above 3. Sleep difficulty, assessed using the Sleep Condition Indicator (SCI), measured at weekly intervals during baseline and treatment periods in addition to the above 4. Wellbeing, assessed using the 14-item Warwick-Edinburgh Mental Well-being Scale (WEMWBS) 5. Health-related quality of life, assessed using the Patient-Generated Index (PGI) 6. Work productivity and activity, assessed using the Work Productivity and Activity Impairment (WPAI) questionnaire 7. Cognitive behavioural therapy skills acquisition, assessed using the Cognitive Behavioural Therapy Skills Questionnaire (CBTSQ)

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Countries

United Kingdom

Contacts

Public ContactJenny Gu

Outcome results

None listed

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