Clinical trial NCT04847310: Cost-benefit Evaluation of a Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care
Official title: Cost-effectiveness and Cost-Utility Evaluation of the Individual vs. Group Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care (PsicAP-Costs)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Emotional Disorder
Depression
Somatoform Disorders
Anxiety Disorders
Keywords: transdiagnostic therapy
emotional disorders
primary care
cost-benefit analysis
brief psychological treatments
randomized controlled trial
depression
anxiety disorders
somatoform disorders
Lead sponsor: Universidad de Córdoba
Sponsor class: OTHER
Collaborators: name: State Research Agency, Spain
First posted: 2021-04-19
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter randomized controlled trial with pre-post measures and follow-ups.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in depression symptoms: 9-item Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, immediately after the intervention, and follow-ups (6 and 12 months)
measure: Change in anxiety symptoms: 7-item General Anxiety Disorder scale (GAD-7)
timeFrame: Baseline, immediately after the intervention, and follow-ups (6 and 12 months)
measure: Change in panic symptoms: Patient Health Questionnaire-Panic Disorder (PHQ-PD)
timeFrame: Baseline, immediately after the intervention, and follow-ups (6 and 12 months)
measure: Change in somatoform symptoms: 15-item Patient Health Questionnaire (PHQ-15)
timeFrame: Baseline, immediately after the intervention, and follow-ups (6 and 12 months)
Secondary outcomes:
measure: Change in the level of impairment: Sheehan Disability Scale (SDS)
timeFrame: Baseline, immediately after the intervention, and follow-ups (6 and 12 months)
measure: Change in general quality of life: World Health Organization Quality of Life Instrument-Brief version (WHOQOL-BREF)
timeFrame: Baseline, immediately after the intervention, and follow-ups (6 and 12 months)
measure: Change in ruminative responses: Ruminative Responses Scale (RRS)
timeFrame: Baseline, immediately after the intervention, and follow-ups (6 and 12 months)
measure: Change in worry: Penn State Worry Questionnaire (PSWQ)
timeFrame: Baseline, immediately after the intervention, and follow-ups (6 and 12 months)
measure: Change in attentional and interpretational biases: Inventory of Cognitive Activity in Anxiety Disorders (IACTA) and Questionnaire of Cognitive Distortions in Emotional Disorders (CDTE)
timeFrame: Baseline, immediately after the intervention, and follow-ups (6 and 12 months)
measure: Change in emotion regulation strategies: Cognitive Emotion Regulation Questionnaire (CERQ)
timeFrame: Baseline, immediately after the intervention, and follow-ups (6 and 12 months)
measure: Change in metacognitions: 30-item Metacognitions Questionnaire (MCQ-30)
timeFrame: Baseline, immediately after the intervention, and follow-ups (6 and 12 months)
measure: Sociodemographic and medical data, and treatment satisfaction
timeFrame: Baseline, immediately after the intervention, and follow-ups (6 and 12 months)
measure: Cost and utility data
timeFrame: Baseline, immediately after the intervention, and follow-ups (6 and 12 months)
measure: Presence of eating disorders or alcohol abuse (exclusion criterion)
timeFrame: Pre-intervention (screening)
Other outcomes:
measure: Presence of emotional disorder (inclusion criterion): Patient Health Questionnaire 4 items (PHQ-4)
timeFrame: Pre-intervention (screening)
measure: Presence of severe mental disorders (exclusion criterion)
timeFrame: Pre-intervention (screening)
Locations:
city: Montilla
country: Spain
facility: Unidad de Salud Mental Comunitaria Montilla
state: Córdoba
city: Córdoba
country: Spain
facility: Centro Sanitario "Levante Sur Dr. Manuel Barragán Solís"
city: Córdoba
country: Spain
facility: Centro Sanitario "Carlos Castilla del Pino"
Study officials:
affiliation: Universidad de Córdoba
name: Juan Antonio Moriana Elvira, PhD
role: PRINCIPAL_INVESTIGATOR
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