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The effect of Cognitive behaviour therapy on adult mental health during the COVID-19 pandemic.

A pragmatic study to disseminate low intensity, evidence supported Cognitive behaviour therapy and the effect on anxiety and depression in adults during the COVID-19 pandemic

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000779976
Enrollment
225
Registered
2020-07-30
Start date
2020-08-06
Completion date
2020-09-30
Last updated
2024-08-19

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

Conditions

None listed

Brief summary

In these unprecedented times of global concern associated with the effects of COVID-19, the aim of the study is to produce and disseminate a low-intensity, self-help CBT guide to coping with anxiety and depression during the COVID-19 pandemic. This will include information for use with regards to children (use of parts relating to children will be facilitated by adult participants only), adolescents (use of parts relating to adolescents will be facilitated by adult participants only), and adults (including older adults) and include simplified CBT coping strategies as well as a comprehensive resource list of the many internet-based CBT programs, websites, and self-help books available as e-books to help people recognize and address different types of unhelpful thought patterns and behaviours which may contribute to heightened anxiety and depression during the pandemic. The recommendations for coping strategies and resources will be compiled by an international panel of experts in CBT. The guide will be disseminated through GP practices, WA hospitals, public mental health services, private mental health services and WA government websites, and the research will involve feedback from consumers on the relevance and usefulness of the information in relation to their stress, worry and low mood related to the pandemic. The information will be evaluated for the effectiveness of the treatment on symptoms of anxiety and depression. Research Questions and Hypotheses: 1. Do adult consumers find the CBT strategies to improving mental health guide for COVID-19 useful as indicated by their qualitative feedback in interviews? Due to the exploratory nature of this question no specific hypotheses are outlined. 2. Is there evidence through a pilot investigation of the efficacy of the guide in decreasing anxiety and depression in adults? It is hypothesised that participants randomised to the intervention will show significantly lower symptoms of anxiety on the GAD-7 and depression on the PHQ-9 after 1 week compared to control participants. 3. Can a CBT guide to improving mental health during COVID-19 be produced which covers strategies for both and adults and children (including those with specific needs, for example children with special needs such as Autism; use of parts relating to children will be facilitated by adult participants only)?

Interventions

Intervention group names: Immediate and Waitlist The study will involve providing participants with a low-intensity, self-help CBT guide to coping with anxiety and depression during the COVID-19 pandemic, developed specifically for the current study. This will include information for children (use of parts relating to children will be facilitated by adult participants only), adolescents (use of parts relating to adolescents will be facilitated by adult participants only), and adults (including

Intervention group names: Immediate and Waitlist The study will involve providing participants with a low-intensity, self-help CBT guide to coping with anxiety and depression during the COVID-19 pandemic, developed specifically for the current study. This will include information for children (use of parts relating to children will be facilitated by adult participants only), adolescents (use of parts relating to adolescents will be facilitated by adult participants only), and adults (including older adults), and include simplified CBT coping strategies as well as a comprehensive resource list of the many internet-based CBT programs, websites, and self-help books available as e-books to help people recognize and address different types of unhelpful thought patterns and behaviours which may contribute to heightened anxiety and depression during the pandemic. Coping strategies included in the guide include: - Taking action to protect yourself against COVID-19 by following expert guidelines (COVID-19 specific) - Engage in general self-care (non-COVD-19 specific) - Engage in pleasant events (non-COVD-19 specific) - Ways to deal with worry and rumination (non-COVD-19 specific) - Ways to deal with anxiety over your health (non-COVD-19 specific) - Ways to deal with anxiety over your finances (non-COVD-19 specific) - Engage in problem solving (non-COVD-19 specific) - Relaxation Exercises (non-COVD-19 specific) - Mindfulness (non-COVD-19 specific) - Exercise (non-COVD-19 specific) - Challenge unhelpful thoughts with thought records (non-COVD-19 specific) - Challenging unhelpful thoughts with behavioural experiments (non-COVD-19 specific) All participants will be provided with an online information and consent form outlining what will be involved in the trial. Once they have provided consent (by completing the form online), they will complete a form with a set of screening questions to assess their potential suicidality risk. Those who are high-risk will be directed to alternative mental health services (via email) and will be exited from the trial. Those who are low-risk will then go on to complete the pre-intervention questionnaire (online survey), which will include demographics questions, a measure of anxiety (GADS-7) and a measure of depression (PHQ-9). Participants will then be randomised (automatically through the survey software) to one of the two groups. Immediate intervention group: Participants in the Immediate Group will be emailed the CBT self-help guide immediately, and will be directed to spend the next week reading over the information. At the end of one week accessing the guide, they will be emailed an online link to the post-intervention questionnaire. This questionnaire will once again include the GAD-7 and PHQ-9, as well as questions relating to participant's use of and adherence to the strategies presented within the guide (e.g., how many hours spent reading the guide, what percentage of the guide was read, which of the strategies or external resources were used). Waitlist intervention group: Participants in the Waitlist Group will be informed via email that they will be emailed the CBT self-help guide in one week's time. One week after completing the pre-intervention questionnaire, they will be emailed an online link to the post-intervention questionnaire. After completing the post-intervention questionnaire, they will be emailed the CBT self-help guide. All participants who complete the post-intervention questionnaire will be emailed a $20 Amazon voucher. The survey will also include a final question asking if they would like to participate in a feedback interview via phone or internet with one of the research assistants. If they agree to participate in the interview, they will be emailed a link to a second information and consent form explaining what the interview will involve. Once they provide consent, they will then be emailed a link to a bookings website where they will be able to select a time and date for the interview. Once a time is scheduled, one of the research assistants will contact the participant in order to arrange either a phone call or a call over the internet. The research assistants, who are provisionally and generally registered psychologists with experience conducting feedback interviews for research, will conduct the remote interviews from a secure and confidential location. Participants who complete the feedback interviews will be emailed an additional $20 Amazon voucher. Fidelity will be checked using a random selection of the interviews, which will be transcribed, by cross-checking the transcriptions against the list of feedback questions to be covered in the interviews.

Sponsors

Dr Sarah Egan
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Participants who are 18 years of age or over, low risk in terms of their suicidality (i.e., those who score below 6 on a set of screening questions to assess risk of suicidality sourced from the MINI-5.0), and have access to a computer or smart phone will be eligible to participate.

Exclusion criteria

Those who participate will complete a set of screening questions to assess risk of suicidality (sourced from the MINI-5.0), and only low-risk participants (those who score below 6) will be included in the trial. Those who score as moderate-high-risk (6 or more) will not be eligible, however they will be directed to alternative sources of support and will still be provided with the guide.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026