Study Protocol for a Feasibility Study of a Novel ACT-based eHealth Psychoeducational Intervention for Students With Mental Distress

Swansea University

Status: Completed

Conditions: A Wait-list Control; A Bite of ACT' (BOA) Acceptance and Commitment Therapy Online Psychoeducation Course

Treatments: Other: 'A Bite of ACT' (BOA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03810131

DEdwards

Details and patient eligibility

About

Here we propose a protocol for assessing the feasibility and acceptability of a randomised controlled trial (RCT) of an online transdiagnostic psychoeducational intervention called 'A Bite of ACT' (BOA) compared to a waitlist control.

Full description

Introduction: Recent studies reveal a high prevalence of depression, anxiety, and stress symptoms among university students, highlighting an urgent need for preventative measures at low cost to better support often overwhelmed support services.

Objectives: Here we propose a protocol for assessing the feasibility and acceptability of a randomised controlled trial (RCT) of an online transdiagnostic psychoeducational intervention called 'A Bite of ACT' (BOA) compared to a waitlist control.

Methods and analysis:

A randomised controlled trial with crossover design will be conducted at baseline, and two follow-up periods. The primary outcome measure will be the ACCEPT checklist, while secondary outcomes include measures of wellbeing, depression, anxiety, and stress (DASS21) and a process measure (psychological flexibility AAQII). Qualitative interviews and preliminary health economics analysis will provide additional insights. Analysis will focus on descriptive statistics and feasibility outcomes and calculate a treatment effect size to determine sample size needed for any future trial (if indicated).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Participants will be included in the study if they report any feelings of depression, anxiety, and stress (regardless of severity). Participants with an existing psychological disorder will be eligible for the study as long as they are receiving treatment for the disorder and that this treatment does not change over the duration of the study proposed here. Clear instructions will be provided indicating that our BOA intervention should not be used as an alternative to GP/NHS prescribed medication or psychological interventions such as CBT.

2. Participants will need normal or corrected to normal vision and to be able to read and write English.

Exclusion criteria

• 1. Participants will be excluded if they do not have mental distress as stated above.

2. Participants will be excluded if they do not have normal or corrected to normal vision and to be able to read and write English.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Waitlist control

No Intervention group

Description:

This is a group who are waiting for treatment (the control group)

BOA online intervention

Experimental group

Description:

The is the group who are receiving the BOA online intervention.

Treatment:

Other: 'A Bite of ACT' (BOA)