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

A Bite of ACT' (BOA) Acceptance and Commitment Therapy Online Psychoeducation Course Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810131
• Other study ID #: DEdwards
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: Swansea University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• 'A Bite of ACT' (BOA)
An online Acceptance and Commitment Therapy transdiagnostic psychoeducational intervention called 'A Bite of ACT' (BOA)

Locations

Country	Name	City	State
United Kingdom	Swansea University	Swansea	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Swansea University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart rate variability (HRV)	Heart rate variability (HRV). This measures the beat-to-beat variation of the R-R intervals of the electrocardiogram recording and is controlled via the sympathetic and parasympathetic components of the autonomic nervous system (ANS). This is a commonly indexed measure of vagal function and important mediator of health and wellbeing associated with emotion regulation and longevity (Kemp, Arias, et al., 2017) . Measurement of the HRV to assess autonomic changes can be performed using a sensitive and non-invasive technique through an electrocardiogram.	One years (anticipated)
Other	Mindfulness Attention Awareness Scale (MAAS)	Mindfulness Attention Awareness Scale (MAAS). This is a 15-item scale and is used to measure participant's awareness of moment to moment experiences. This mindful self-awareness can be improved through practicing mindfulness. Also, the absence of this skill correlates with decreased self-awareness (Brown & Ryan, 2003). The scale is rated from 1 (almost always) to 6 (almost never) and are then averaged. The internal validity of the MAAS is high where a Cronbach's alpha coefficient of 0.83 has been reported (Frewen, Evans, Maraj, Dozois, & Partridge, 2008).	One years (anticipated)
Other	Acceptance and Action Questionnaire	Acceptance and Action Questionnaire- second version (AAQ-II). This is a 10 item scale, developed by (Bond et al., 2011) to measure psychological flexibility which involves the ability to accept and be open to difficult thoughts and feelings as well as engage in valued behaviour in the presence of the difficult thoughts and feelings. Higher scores indicate higher psychological flexibility, and the measure has good construct validity with a Cronbach's alpha coefficient of 0.84 (Bond et al., 2011).	One years (anticipated)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)