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

NCT ID: NCT03810131

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-11-01

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).

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Waitlist control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

BOA online intervention

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

Group Type EXPERIMENTAL

'A Bite of ACT' (BOA)

Intervention Type OTHER

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

Interventions

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'A Bite of ACT' (BOA)

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

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swansea University

OTHER

Sponsor Role lead

Responsible Party

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Darren Edwards

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Swansea University

Swansea, Wales, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 31315873 (View on PubMed)

Other Identifiers

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DEdwards

Identifier Type: -

Identifier Source: org_study_id