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Implementing Online Mental Health Program

ConditionsStressHealthcare WorkersMindfulnessPrevention Intervention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

About this trial

This study evaluates the feasibility, acceptability, and sustainability of MINDxYOU, a self-guided online psychotherapy program designed to reduce stress and improve the mental well-being of healthcare professionals in the Andalusian public health system. The trial uses a hybrid type 3 effectiveness-implementation design, combining the evaluation of implementation outcomes with observation of clinical effects on stress, anxiety, and depression. The intervention includes mindfulness, compassion, and acceptance-based practices delivered in four online modules over eight weeks. The study will be conducted in two phases: an initial hospital-based pilot and a broader rollout across primary care and hospital centers. Results will help identify how digital mental health interventions can be integrated into routine healthcare settings to support professionals working under high stress.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Being a current healthcare professional.

Age between 18 and 70 years.

Ability to understand Spanish.

Digital literacy and access to a smartphone, tablet or computer with internet connection.

Disqualifiers

Diagnosis of serious mental illness.

Suicidal ideation.

Substance abuse or related disorders.

Trial design

Design model

Single group

Treatments tested in this trial

  • MINDxYOU

    Behavioral

    The online program MINDxYOU is based on the principles of 'third wave' psychotherapies and it is an online program particularly addressed at healthcare providers which will both monitor and support the individual's mental health. The program is self-administered and will be delivered via the Internet and available via smartphone, tablet, and personal computer.

Treatment groups

130 Participants
are divided into 1 treatment group
Group A: MINDxYOUExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of Intervention Measure (FIM)

Includes 4 items designed to measure appropriateness of the intervention. The scale presents 5-point Likert-type scale (1 = completely disagree, 2 = in disagreement, 3 = neither agree nor disagree, 4 = agree and 5 = completely agree). A total score, ranging from 0 to 20, is calculated by totalling the scores from all the items, and higher total values indicate higher level of Feasibility of the intervention

Time frame
Post-treatment 10 weeks from baseline
2

System Usability Scale (SUS)

It is a 10-item questionnaire to measure the usability which qualitatively is related with the quality and acceptability of the intervention. The scale presents 5-point Likert-type scale (0 = never, 1 = almost never, 2 = often, 3 = sometimes and 4 = always). A total score, ranging from 0 to 40, is calculated by totalling the scores from all the items, and higher total values indicate higher level of acceptability of the intervention

Time frame
Post-treatment, 10 weeks from baseline
3

Client Satisfaction Questionnaire adapted to Internet-Based interventions (CSQ-I)

It is an 8-item, 4-point Likert scale questionnaire that assesses the general satisfaction of the participants regarding the received intervention. The total score ranges from 8 to 32.

Time frame
Post-treatment 10 weeks from baseline

Secondary outcomes

1

Perceived Stress Scale (PSS)

Consists of 10 items in which participants are asked to rate how unpredictable, uncontrollable, and overloaded they have found their life over the past month on a 5-point Likert-type scale. Scores range from 0 to 40, and higher scores reflect higher levels of perceived stress.

Time frame
Baseline
2

Perceived Stress Scale (PSS)

Consists of 10 items in which participants are asked to rate how unpredictable, uncontrollable, and overloaded they have found their life over the past month on a 5-point Likert-type scale. Scores range from 0 to 40, and higher scores reflect higher levels of perceived stress.

Time frame
Post-treatment 10 weeks from baseline
3

Patient Health Questionnaire (PHQ-9)

It is a 9-item scale aimed at screening for depression in primary care and other medical settings. It assesses the frequency of depressive symptoms during the last 2 weeks using a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with higher scores indicating higher severity of depression.

Time frame
Baseline
4

Patient Health Questionnaire (PHQ-9)

It is a 9-item scale aimed at screening for depression in primary care and other medical settings. It assesses the frequency of depressive symptoms during the last 2 weeks using a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with higher scores indicating higher severity of depression.

Time frame
Post-treatment 10 weeks from baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Lead sponsor

Hospital Miguel Servet

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: