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

NCT05314920 | Unknown

• 1 other identifier: PsicAP-Costs2
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (2)

• Change in cost-effectiveness data

  Cost-effectiveness results will be calculated by the ICER, defined as the difference in mean costs between interventions divided by the difference in their effectiveness according to the symptom questionnaires' mean scores. The healthcare data collected will be used for cost calculations. To calculate healthcare-related costs, an ad hoc questionnaire will be used to collect emotional disorder-related healthcare data (public and private healthcare consultations, accidents, medical tests, and sick leaves in the past 3 months; psychotropic drugs or other medication, and their posology).

  Baseline, immediately after the intervention, and 12-month follow-up

• Change in cost-utility data

  Cost-utility will be measured through the healthcare data collected above and the European Quality of Life Scale (EuroQoL, EQ) (The EuroQol Group, 1990), calculating the QALYS and the ICURs, defined as the difference in mean cost divided by the difference in mean QALYs. The Spanish version of the 5-domain, 5-level EuroQol (EQ-5D-5L) (Badia et al., 1999; van Reenen et al., 2019) will be used to assess health status in five dimensions (mobility, self-care, daily activities, pain/unease, and anxiety/depression) with five levels of severity (no problems, slight problems, moderate problems, severe problems, and either extreme problems or unable to perform activity).

  Baseline, immediately after the intervention, and 12 month follow-up

Secondary Outcomes (5)

• Change in depressive symptoms: Patient Health Questionnaire - 9 item (PHQ-9)

  Baseline, immediately after the intervention, and 12 month follow-up

• Change in anxiety symptoms: Generalized Anxiety Disorder - 7 item (GAD-7)

  Baseline, immediately after the intervention, and 12 month follow-up

• Change in somatic symptoms: Patient Health Questionnaire - 15 item (PHQ-15)

  Baseline, immediately after the intervention, and 12 month follow-up

• Change in functioning: Sheehan Disability Scale (SDS)

  Baseline, immediately after the intervention, and 12 month follow-up

• Change in treatment satisfaction

  Immediately after the intervention and 12-month follow-up

Other Outcomes (7)

• Change in rumination: Ruminative Responses Scales (brooding subscale) (RRS-B)

  Baseline, immediately after the intervention, and 12-month follow-up

• Change in worry: Penn State Worry Questionnaire - Abbreviated (PSWQ-A)

  Baseline, immediately after the intervention, and 12-month follow-up

• Change in attentional and interpretative biases: Inventory of Cognitive Activity in Anxiety Disorders (IACTA)

  Baseline, immediately after the intervention, and 12-month follow-up

Study Arms (2)

transdiagnostic cognitive-behavioural therapy (TD-CBT)

EXPERIMENTAL

Transdiagnostic cognitive-behavioral group therapy: The psychological interventions will be manualized. Patients assigned to the experimental group will receive 7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals over a 12-week period.

Behavioral: Transdiagnostic cognitive-behavioral therapy (TD-CBT)

relaxation therapy

ACTIVE COMPARATOR

The control group will receive a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure. Patients will receive 7 sessions (1.5 hr/session) in groups of 8-10 individuals over a 12-week period.

Behavioral: Bernstein and Borkovec progressive muscle relaxation (PMR)

Interventions

Transdiagnostic cognitive-behavioral therapy (TD-CBT) BEHAVIORAL

Transdiagnostic cognitive-behavioral therapy (TD-CBT)

transdiagnostic cognitive-behavioural therapy (TD-CBT)

Bernstein and Borkovec progressive muscle relaxation (PMR) BEHAVIORAL

Bernstein and Borkovec progressive muscle relaxation (PMR)

relaxation therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigación Marqués de Valdecilla: lead

Study Sites (4)

Centro Sanitario "Sardinero"

Santander, 39005, Spain

RECRUITING

Centro Sanitario "Dávila"

Santander, 39006, Spain

RECRUITING

Centro Sanitario "Camargo Costa"

Santander, 39600, Spain

RECRUITING

Centro Sanitario "Camargo Interior"

Santander, 39600, Spain

RECRUITING

Related Publications (1)

• Gonzalez-Blanch C, Barrio-Martinez S, Priede A, Martinez-Gomez S, Perez-Garcia-Abad S, Miras-Aguilar M, Ruiz-Gutierrez J, Munoz-Navarro R, Ruiz-Rodriguez P, Medrano LA, Prieto-Vila M, Carpallo-Gonzalez M, Aguilera-Martin A, Galvez-Lara M, Cuadrado F, Moreno E, Garcia-Torres F, Vencesla JF, Corpas J, Jurado-Gonzalez FJ, Moriana JA, Cano-Vindel A. Cost-effectiveness of transdiagnostic group cognitive behavioural therapy versus group relaxation therapy for emotional disorders in primary care (PsicAP-Costs2): Protocol for a multicentre randomised controlled trial. PLoS One. 2023 Mar 16;18(3):e0283104. doi: 10.1371/journal.pone.0283104. eCollection 2023.

  PMID: 36928238 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Somatoform Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

César González-Blanch Bosch, PhD

CONTACT

+34-942-202537; cesar.gonzalezblanch@scsalud.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Outcomes assessors will be blinded during pre- and post-treatment. Participants will be blinded during pretreatment assessment; however, it cannot be guaranteed that they will keep blinded in post-treatment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter randomized controlled trial with pre-post measures and 12-month follow-up.

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: April 7, 2022
• Study Start: January 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)