Clinical trial NCT05314920: Cost-effectiveness of a Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care
Official title: Cost-effectiveness of Transdiagnostic Group Psychological Treatment for Common Mental Disorders in Primary Care (PsicAP-Costs2): a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotional Disorder
Keywords: transdiagnostic therapy
emotional disorders
primary care
cost-benefit analysis
brief psychological treatments
cognitive behavioral therapy
randomized controlled trial
depression
anxiety disorders
somatoform disorders
Lead sponsor: Instituto de Investigación Marqués de Valdecilla
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 300
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 12-month follow-up.
Primary purpose: OTHER

Brief summary: The aim of this study is to test the cost-effectiveness and cost-utility of adding a transdiagnostic group cognitive-behavioural therapy (TD-CBT) to treatment as usual (TAU) for emotional disorders in primary care . A single-blind randomized controlled clinical trial will be conducted to compare the TD-CBT group therapy plus TAU to progressive muscle relaxation (PMR) group plus TAU in individuals, aged 18 to 65, with emotional disorders in four primary care centres located in Cantabria, Spain. The study will take a societal perspective. Psychological assessments will be carried out at baseline, post-treatment, and 12-months follow-up. The assessments will include measures of clinical symptoms (anxiety, depression, and/or somatic), dysfunction, cognitive-emotional factors (ruminative processes, pathological concern, attentional and interpretative biases, emotion regulation strategies and meta-cognitive beliefs), and satisfaction with the treatment received. Data on health service use, including medication and days of absence from work, will be collected from electronic medical records. The primary outcomes are the incremental cost-effectiveness ratios (ICER) based on the difference in mean costs and effectiveness between interventions and incremental cost-utility ratios (ICURs) based on health-related quality of life at post-treatment and 12-month follow-up. Secondary outcome measures include clinical symptoms, quality of life, functioning and treatment satisfaction. Bootstrap sampling will be used to assess the uncertainty of the results. Secondary moderation and mediation analyses will also be conducted. In addition, in sessions' number 1, 4 and 7 of both treatment arms, two questionnaires will be administered that collect therapeutic alliance and group satisfaction. The main study hypothesis is that adding TD-CBT to TAU in primary care will be more cost-effective than TAU plus PMR. In addition, these gains will be maintained in the 12-month follow-up. If it is successful, the dissemination of cost-effective treatment can help to overcome problems in accessing psychological treatment for emotional disorders in the context of an increasing demand for mental healthcare in primary care.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 65, inclusive, who present to the PC centre seeking treatment for anxiety, depressive or somatic symptoms.
* Scores above the predetermined cut-off points on the GAD-7 (\>= 10), the PHQ-9 (\>= 10) or the PHQ-15 (\>=10 plus a score of 2 in three or more somatic symptoms).
* Agreement to participate in the study, with written informed consent.

Exclusion Criteria:

* Major depressive disorder (PHQ-9\> 24) and/or severe disability (SDS \> 25) will be interviewed by a clinician for the presence of any severe mental disorder, including autism spectrum disorders, bipolar disorder, schizophrenia, anorexia nervosa, substance dependence, personality disorder.
* Presence of severe or recent suicide attempts
* Presence of intellectual disability (IQ \< 70).
* Be receiving psychological treatment or any type of specialized care related to mental health.
* Insufficient Spanish language skills

Primary outcomes:
measure: Change in cost-effectiveness data
timeFrame: Baseline, immediately after the intervention, and 12-month follow-up
measure: Change in cost-utility data
timeFrame: Baseline, immediately after the intervention, and 12 month follow-up
Secondary outcomes:
measure: Change in depressive symptoms: Patient Health Questionnaire - 9 item (PHQ-9)
timeFrame: Baseline, immediately after the intervention, and 12 month follow-up
measure: Change in anxiety symptoms: Generalized Anxiety Disorder - 7 item (GAD-7)
timeFrame: Baseline, immediately after the intervention, and 12 month follow-up
measure: Change in somatic symptoms: Patient Health Questionnaire - 15 item (PHQ-15)
timeFrame: Baseline, immediately after the intervention, and 12 month follow-up
measure: Change in functioning: Sheehan Disability Scale (SDS)
timeFrame: Baseline, immediately after the intervention, and 12 month follow-up
measure: Change in treatment satisfaction
timeFrame: Immediately after the intervention and 12-month follow-up
Other outcomes:
measure: Change in rumination: Ruminative Responses Scales (brooding subscale) (RRS-B)
timeFrame: Baseline, immediately after the intervention, and 12-month follow-up
measure: Change in worry: Penn State Worry Questionnaire - Abbreviated (PSWQ-A)
timeFrame: Baseline, immediately after the intervention, and 12-month follow-up
measure: Change in attentional and interpretative biases: Inventory of Cognitive Activity in Anxiety Disorders (IACTA)
timeFrame: Baseline, immediately after the intervention, and 12-month follow-up
measure: Change in emotion regulation: Cognitive Emotion Regulation Questionnaire (CERQ)
timeFrame: Baseline, immediately after the intervention, and 12-month follow-up
measure: Change in metacognitive beliefs: Metacognitions Questionnaire (negative beliefs subscale) (MCQ)
timeFrame: Baseline, immediately after the intervention, and 12-month follow-up
measure: Change in cognitive Distortions in Emotional Disorders (CDTE)
timeFrame: Baseline, immediately after the intervention, and 12-month follow-up
measure: Change in alliance: Working Alliance Inventory Patient Form (WAI-P) and Group Session Rating Scale (GSRS)
timeFrame: In therapy sessions number 1, 4 and 7
Locations:
city: Santander
country: Spain
facility: Centro Sanitario "Sardinero"
city: Santander
country: Spain
facility: Centro Sanitario "Dávila"
city: Santander
country: Spain
facility: Centro Sanitario "Camargo Costa"
city: Santander
country: Spain
facility: Centro Sanitario "Camargo Interior"
Study officials:
References: