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A single session intervention for anxiety and depression: a randomised controlled trial

Effect of a single vs. multi-session intervention on anxiety and depression symptoms in adults: a randomised controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001617853
Enrollment
242
Registered
2021-11-26
Start date
2022-02-08
Completion date
2022-08-18
Last updated
2023-11-20

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

Conditions

None listed

Brief summary

The primary aim of this project is to determine whether a single session intervention is no less effective (i.e., non-inferior) in reducing anxiety and depressive symptoms compared to a multi-session intervention, the Wellbeing Course. The secondary aim of this project is to determine whether the single session intervention is more effective than a waitlist control group. Participants in the SSI will receive access to a single online lesson and will be invited to contact the clinician within the 1-week following the release of the lesson. Participants in the MSI will receive access to the 8-week intervention and contact with the clinician. Participants in the Waitlist Control Group will receive access to the MSI following the 8-week waitlist period. All participants will complete questionnaires at assessment, pre-treatment, and then 4-weeks, 8-weeks, and 17-weeks later. The primary endpoint will be 8-weeks after pre-treatment (i.e., Week 9).

Interventions

A three-arm randomized controlled trial will be employed, where participants are randomized to one of three groups: 1. Single session intervention 2. Multi session intervention 3. Waitlist Control The Single Session Intervention comprises of a single online lesson which provides psychoeducation about the nature of anxiety and depression, recommendations for self-management of symptoms, and one week of optional contact with a clinician from the eCentreClinic. The lesson is based on Lesson 1 of t

A three-arm randomized controlled trial will be employed, where participants are randomized to one of three groups: 1. Single session intervention 2. Multi session intervention 3. Waitlist Control The Single Session Intervention comprises of a single online lesson which provides psychoeducation about the nature of anxiety and depression, recommendations for self-management of symptoms, and one week of optional contact with a clinician from the eCentreClinic. The lesson is based on Lesson 1 of the Wellbeing Course with four additional slides which outline possible strategies for participants to practice. This intervention will also include practice exercises, an additional resource on problem solving, and case stories from example participants to illustrate the skills. It is expected that participants will take 60 minutes to read the lesson, read the practice exercises and resource, and read the case stories. Additional skills practice is at the discretion of the participant. The psychologist will contact participants to arrange a telephone call within a week of this lesson being released. Participants will be able to speak over the phone with the psychologist within a week of the participant viewing the lesson (i.e., this contact is not limited to the week that the treatment becomes available to accommodate participant availability). There is no time limit to this telephone consult or private messages, although it is expected that phone consults will be 20-30 minutes long. Additional contact outside this week will be made if participants indicate that they are at risk of suicide/ self-harm or are experiencing technical difficulties. The second treatment is the Wellbeing Course. This Course is based on cognitive behaviour therapy and includes five lessons released over an 8-week period, in addition to optional contact with a clinician from the eCentreClinic. The five lessons focus on psychoeducation (Lesson 1), cognitive challenging (Lesson 2), arousal management (Lesson 3), activity scheduling and exposure (Lesson 4), and relapse management (Lesson 5). This Course also includes additional resources (e.g., assertive communication), case stories from past participants, and automatic emails on a weekly basis. Participants are expected to spend 3-4 hours a week working through the Wellbeing Course materials - this includes reading the lesson, thinking about the content, and practicing the skills. The contact with a psychologist will be via telephone or private messaging. From past clinical experience, this is usually one 20-30 min phone call or 3-4 private messages per week. Lessons in the single session and multi-session intervention consist of text and static images (i.e., no video or audio). The Wellbeing Course has been used in several past clinical trials and is provided at the MindSpot Clinic (https://mindspot.org.au/wellbeing-course).

Sponsors

Macquarie University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

(a) Australian resident (b) Are aged 18 years or older (c) Report primary difficulties with anxiety and/or depression

Exclusion criteria

(a) Actively suicidal or unable to keep themselves safe (b) Living outside of Australia (c) Unable to read and understand English.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026