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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

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

Intervention / Treatment
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* Other: 'A Bite of ACT' (BOA)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Waitlist control<br>This is a group who are waiting for treatment (the control group) | |
| Experimental: BOA online intervention<br>The is the group who are receiving the BOA online intervention. | Other: 'A Bite of ACT' (BOA)<br>* An online Acceptance and Commitment Therapy transdiagnostic psychoeducational intervention called 'A Bite of ACT' (BOA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance Checklist for Clinical Effectiveness Pilot Trials (ACCEPT) (Charlesworth, Burnell, Hoe, Orrell, & Russell, 2013) | Acceptance Checklist for Clinical Effectiveness Pilot Trials (ACCEPT) | One years (anticipated) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Anxiety Stress Scales | Depression Anxiety Stress Scales (short-form DASS-21). This is the short version of this measure and is a general psychological distress measure with good construct validity (confirmatory factor analysis of 0.94). It has good internal reliability as measured through Cronbach's alpha coefficients, which are 0.88 for depression, 0.82 for anxiety, 0.90 for stress and 0.93 for the total scale (Henry & Crawford, 2005). | One years (anticipated) | 
| Social connectedness | Social connectedness (adapted from Russell's (1996) UCLA Loneliness Scale (Kok et al., 2013). This includes two questions; (1) During these social interactions, I felt 'in tune' with the person/s around me, and (2) During these social interactions, I felt close to the person/s. Responses are made on a 7-point scale (1 = not at all true, 7 = very true). The Cronbach's alpha coefficients for these two items ranged from .80 to .98 (M = .94, SD = .03) (Kok et al., 2013). | One years (anticipated) | 
| EuroQol five dimensions | EuroQol five dimensions (EQ5D). The EQ5D is a measure for health-related quality of life (HRQOL) statues. Within it, there are five components which assess mobility, self-care, usual activities, pain and discomfort, as well as anxiety. It also has a visual analogue scale (VAS) for measuring current health status. Scores for these will be calculated for each of these five subsections as well as including the VIS and total EQ5D score of all five subsections. The EQD5 correlates well with other health related questionnaires such as the SF-36 (r = 0.61, p<0.0001) and PDQ-39 (r = -0.75, p<0.0001) (Schrag, Selai, Jahanshahi, & Quinn, 2000). | One years (anticipated) | 
| Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) | Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) (Tennant et al., 2007). Is a measure of mental well-being with a focus on positive aspects of mental health. It has good internal consistency with a Cronbach's alpha coefficient of 0.89 (student sample) and 0.91 (general population sample). | One years (anticipated) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acceptance and Commitment Therapy