Cost-effectiveness and Implementation of a Transdiagnostic Internet-based Intervention for Emotional Disorders in Community Care.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitat Jaume I

About this trial

Emotional disorders (ED) are one of the leading causes of disability. They are highly prevalent and have an impact on quality of life. Addressing them places an overload on the National Health System (NHS), generating waiting lists and limiting appropriate care. The need for cost-effective solutions has led to the consideration of the transdiagnostic approach and the use of digital solutions. Both perspectives have demonstrated efficacy in a large number of randomized clinical trials. As a result, investment in digital health interventions is on the rise to improve access to care in overburdened healthcare systems. However, their integration and implementation in health systems remains limited. Implementation Science emerges to facilitate the integration of interventions into clinical practice through specific strategies that overcome barriers and optimize their sustainability. The objective of this project is to examine the effectiveness, economic costs and feasibility of implementing an online psychological treatment program for emotional disorders in mental health services. The Mutua and UJI teams have already carried out the transfer of the online program. In order to facilitate the adoption and sustainability of this program and that it can be used by mental health professionals in daily practice, a hybrid design 1 study will be carried out in which not only the efficacy but also the possibility of adoption and the analysis of economic costs in comparison with the usual treatment will be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Over 18 years of age.

Meet the diagnostic criteria for an anxiety or depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

Understand and read Spanish or Catalan.

Have access to the Internet and an email address

Disqualifiers

Diagnosis of schizophrenia, bipolar disorder, or alcohol or substance dependence.

High risk of suicide.

Presence of a medical condition that prevents psychological treatment.

Receiving other psychological treatment (other than TAU or the online program) during the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Internet-based psychological intervention

    Behavioral

    This protocol consists of a set of techniques that have proven effective in improving the lives of people with emotional disorders and is designed to be applied via the Internet. Its objective is to teach strategies that improve the ability to regulate emotions in a more adaptive way. It includes the following core therapeutic components, aimed primarily at regulating negative affect: a) emotional awareness focused on the present moment and acceptance, b) cognitive flexibility, c) emotional and behavioral avoidance, and d) exposure to emotional experiences (interoceptive and situational). In addition, the protocol also includes traditional evidence-based components for the treatment of emotional disorders, such as psychoeducation, motivation for change, and relapse prevention. Finally, it also includes a specific component for regulating positive affect, with the aim of promoting psychological strengths and improving well-being.

  • Treatment as usual (TAU)

    Behavioral

    TAU may include pharmacological treatment (antidepressants and/or anxiolytics), psychological treatments (case management, group therapy, empathic listening, and counseling and advice), mental health nursing follow-up with psychosocial interventions, or a combination thereof. Participants in TAU and receiving treatment outside the center will be excluded from the study. The specific treatment received by each patient will be recorded. After the study, TAU participants will be given access to online treatment.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Transdiagnostic intervention protocolExperimental treatment 1 intervention
Group B: Treatment as usual (TAU)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Level of effectiveness of the intervention in reducing depressive symptoms using the Overall Depression Severity and Impairment Scale (ODSIS)

Scores equal to or greater than 5 discriminate patients with clinical depressive symptoms.

Time frame
Baseline, at the end of the intervention and follow-up at 3, 6, 9 and 12 months.
2

Level of effectiveness of the intervention in reducing anxiety symptoms using the Overall Anxiety Severity and Impairment Scale (OASIS)

Scores equal to or greater than 7 discriminate patients with symptoms of clinical anxiety.

Time frame
Baseline, at the end of the intervention and follow-up at 3, 6, 9 and 12 months.
3

Level of effectiveness of the intervention in improving positive and negative affect using the Positive and Negative Affect Scale (PANAS)

2 subscales: Negative and Positive Affect. Higher scores in each subscale indicates more neuroticism and positive affect, respectively.

Time frame
Baseline, at the end of the intervention and follow-up at 3, 6, 9 and 12 months.
4

Level of effectiveness of the intervention in improving quality of life using the EuroQoL-5D-3L

This questionnaire describes health status in terms of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) according to five levels of severity. The experimental group will experience a more substantial improvement in quality of life compared to the TAU group, as evidenced by superior outcomes on the European Quality of Life 5D (EUROQOL).

Time frame
Baseline, at the end of the intervention and follow-up at 3, 6, 9 and 12 months.

Secondary outcomes

1

Level of acceptability of the intervention using the System Usability Scale (SUS)

Cut-off: a score of 68 and higher is considered acceptable usability.

Time frame
At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
2

Level of acceptability of the intervention using the Acceptability of Intervention Measure (AIM)

Cut-off scores for interpretation are not yet available; however, higher scores indicate greater acceptability.

Time frame
At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
3

Level of acceptability of the intervention using the Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I).

Cut-off scores for interpretation are not yet available; however, higher scores indicate greater client satisfaction and acceptability.

Time frame
At the end of the intervention and follow-up at 3, 6, 9 and 12 months.
4

Level of feasibility of the intervention using the Feasibility of Intervention Measure (FIM)

Cut-off scores for interpretation are not yet available; however, higher scores indicate greater feasibility.

Time frame
At the end of the intervention and follow-up at 3, 6, 9 and 12 months.

Other outcomes

Sponsors and contacts

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Universitat Jaume I

Lead sponsor

Hospital Mutua de Terrassa

Collaborator

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