Cost-benefit Evaluation of a Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care (PsicAP-Costs)

Universidad de Córdoba

Status: Active, not recruiting

Conditions: Emotional Disorder; Somatoform Disorders; Depression; Anxiety Disorders

Treatments: Other: Individual brief transdiagnostic cognitive-behavioral therapy; Other: Group brief transdiagnostic cognitive-behavioral therapy; Other: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT04847310

PID2019-107243RB-C22

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild/moderate emotional disorder

Exclusion criteria

• Severe mental disorder (including severe depressive or anxiety disorders, not somatizations)
• High level of impairment
• Recent, severe suicide attempt
• No emotional disorder/Below the instruments cut-off points

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 3 patient groups

Group 1

Experimental group

Treatment:

Other: Group brief transdiagnostic cognitive-behavioral therapy

Group 2

Experimental group

Treatment:

Other: Individual brief transdiagnostic cognitive-behavioral therapy

Group 3

Active Comparator group

Treatment:

Other: Treatment as usual