Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04566042
Other study ID # Swansea U1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 31, 2021
Est. completion date December 31, 2022

Study information

Verified date February 2024
Source Swansea University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A feasibility study to explore whether an acceptance and commitment therapy (ACT) can reduce mental health outcomes (stress, anxiety, depression) and increase psychological flexibility.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date December 31, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults reporting some existing form of anxiety, depression or ongoing stress. - Need ability to read and write English. - Need internet access to play the videogame. Exclusion Criteria: - Those who are under 18

Study Design


Intervention

Behavioral:
Acceptance and commitment therapy video game
The intervention is a videogame which teaches the participant about acceptance and commitment therapy.

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
Primary Number of participants recruited for the study Feasibility outcome for recruitment. 3 Weeks
Primary Number of participants who completed all aspects of the study Feasibility outcome for retention of participants. 3 Weeks
Primary Reflexive thematic analysis themes Acceptability of the intervention assessed through qualitative analysis of semi-structured interviews. 3 Weeks; Immediate post intervention, and 3-week follow-up
Secondary Depression Anxiety Stress Scale-21 (Depression subscale) Quantitative psychometric measure for depression. Score Range: Min=0, Max=21. Higher scores indicate higher depression. 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Secondary Depression Anxiety Stress Scale-21 (Anxiety subscale) Quantitative psychometric measure for anxiety. Score Range: Min=0, Max=21. Higher scores indicate higher anxiety. 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Secondary Depression Anxiety Stress Scale-21 (Stress subscale) Quantitative psychometric measure for stress. Score Range: Min=0, Max=21. Higher score indicate higher stress. 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Secondary Acceptance and Action Questionnaire- second version Quantitative psychometric measure for psychological inflexibility. Score Range: Min=7, Max=49. Higher scores indicate higher psychological inflexibility. 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Secondary Social Connectedness (adapted from Russell's (1996) University of California, Los Angeles Loneliness Scale) Quantitative psychometric measure of Social Connectedness. Score range: Min=2, Max=8. Higher scores indicate higher social connectedness. 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Secondary Warwick-Edinburgh Mental Well-Being Scale Quantitative psychometric measure of mental well-being with a focus on positive aspects of mental health. Score Range: Min=14, Max=70. Higher scores indicate higher wellbeing. 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Secondary EuroQol five dimensions (Mobility Subscale) Score Range: Min=1, Max=5. Higher scores indicate lower mobility. 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Secondary EuroQol five dimensions (Self-care Subscale) Score Range: Min=1, Max=5. Higher scores indicate lower self-care. 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Secondary EuroQol five dimensions (Usual Activities Subscale) Score Range: Min=1, Max=5. Higher scores indicate lower partaking in usual activities. 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Secondary EuroQol five dimensions (Pain/Discomfort Subscale) Score Range: Min=1, Max=5. Higher scores indicate lower pain/discomfort. 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Secondary EuroQol five dimensions (Anxiety/Depression Subscale) Score Range: Min=1, Max=5. Higher scores indicate lower anxiety/depression. 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
Secondary EuroQol five dimensions (Score to indicate how health is today) Score Range: Min=0, Max=100. Higher scores indicate higher health. 3 Weeks; Baseline, immediate post intervention, and 3-week folllow-up
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A