NCT04847310

Cost-benefit Evaluation of a Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care

Cost-effectiveness and Cost-Utility Evaluation of the Individual vs. Group Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care (PsicAP-Costs)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Universidad de Córdoba · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare, in cost-effectiveness and cost-utility terms, a brief transdiagnostic cognitive-behavioural therapy in two different modes, individual and group, with the treatment usually administered in primary care (TAU). Participants between 18 and 65 years old and with, according to the pretreatment evaluation, mild to moderate emotional disorders will be randomly allocated to the three clusters. They will be assessed again immediately after treatment and 6 and 12 months later. The study hypotheses expect to find (H1) the individual treatment generally as effective as the group one, whereas (H2) the TAU will be the least effective. (H3) The group therapy is expected to get the best results in terms of cost-effectiveness and (H4) the TAU will get the worst cost-effectiveness results. Furthermore, (H5) it is expected to find these results across the follow-up assessments too.

Conditions

• Emotional Disorder
• Depression
• Somatoform Disorders
• Anxiety Disorders

Interventions

Type	Name	Description
OTHER	Group brief transdiagnostic cognitive-behavioral therapy	An adaptation of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) (Barlow et al., 2015) and the IAPT programme (Clark, 2018). It has been developed by Cano-Vindel (González-Blanch et al., 2018) and consists in seven 90-minute sessions, provided by a non-assessor clinical psychologist in 12-16 weeks, with 8-10 participants per group. Sessions are weekly or biweekly, reducing their frequency as the intervention advances. The activities and homework proposed are supported with materials such as theory documents, a CD for progressive muscle relaxation, self-recording sheets, and a therapy web (www.desordenesemocionales.es).
OTHER	Individual brief transdiagnostic cognitive-behavioral therapy	An adaption of the group therapy, with the same phases. However, since it is an individual intervention, it is more flexible than group one and its contents and duration can be personalized. This intervention consists of a minimum of 6 and a maximum of 8 sessions of 30-60 minutes, provided by a clinical psychologist not involved in the assessments.
OTHER	Treatment as usual	Participants in this group will be provided the common primary care treatment by the GP, in a face-to-face consultation that seldom exceeds 10 minutes. TAU usually consists in pharmacological treatment prescribed by the GP, however, it might also consist in practical advice or even non-treatment (Watts et al., 2015). The first consultation will count as part of the recruitment process and, if the patient accepts to participate in the trial, no therapeutic help will be provided to them until they are allocated. Once in the TAU intervention, if the practitioner recommended any psychological treatment as part of it (e.g., referral to specialized care), the participant would be excluded to avoid contamination between clusters. TAU has not a specific amount of sessions; it will finish when the GP considers the patient is recovered.

Timeline

• Start date: 2021-09-01
• Primary completion: 2025-05-01
• Completion: 2026-04-01
• First posted: 2021-04-19
• Last updated: 2024-04-22

Locations

3 sites across 1 country: Spain