Clinical trial NCT03810131: Study Protocol for a Feasibility Study of a Novel ACT-based eHealth Psychoeducational Intervention for Students With Mental Distress
Official title: Study Protocol for a Feasibility Study of a Novel ACT-based eHealth Psychoeducational Intervention for Students With Mental Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: A Bite of ACT' (BOA) Acceptance and Commitment Therapy Online Psychoeducation Course
A Wait-list Control
Keywords: Acceptance and Commitment Therapy
Lead sponsor: Swansea University
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptance Checklist for Clinical Effectiveness Pilot Trials (ACCEPT) (Charlesworth, Burnell, Hoe, Orrell, & Russell, 2013)
timeFrame: One years (anticipated)
Secondary outcomes:
measure: Depression Anxiety Stress Scales
timeFrame: One years (anticipated)
measure: Social connectedness
timeFrame: One years (anticipated)
measure: EuroQol five dimensions
timeFrame: One years (anticipated)
measure: Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
timeFrame: One years (anticipated)
Other outcomes:
measure: Heart rate variability (HRV)
timeFrame: One years (anticipated)
measure: Mindfulness Attention Awareness Scale (MAAS)
timeFrame: One years (anticipated)
measure: Acceptance and Action Questionnaire
timeFrame: One years (anticipated)
Locations:
city: Swansea
country: United Kingdom
facility: Swansea University
state: Wales
Study officials:
References:
citation: Edwards DJ, Rainey E, Boukouvala V, Wells Y, Bennett P, Tree J, Kemp AH. Novel ACT-based eHealth psychoeducational intervention for students with mental distress: a study protocol for a mixed-methodology pilot trial. BMJ Open. 2019 Jul 16;9(7):e029411. doi: 10.1136/bmjopen-2019-029411.