Cost-effectiveness of a Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care (PsicAP-Costs2)

Cost-effectiveness of Transdiagnostic Group Psychological Treatment for Common Mental Disorders in Primary Care (PsicAP-Costs2): a Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Emotional Disorder
• Intervention / Treatment: Behavioral: Transdiagnostic cognitive-behavioral therapy (TD-CBT); Behavioral: Bernstein and Borkovec progressive muscle relaxation (PMR)

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: César González-Blanch Bosch, PhD; Phone Number: +34-942-202537; Email: cesar.gonzalezblanch@scsalud.es

Study Locations

• Spain
  • Santander, Spain, 39005
    • Recruiting
    • Centro Sanitario "Sardinero"
  • Santander, Spain, 39006
    • Recruiting
    • Centro Sanitario "Dávila"
  • Santander, Spain, 39600
    • Recruiting
    • Centro Sanitario "Camargo Costa"
  • Santander, Spain, 39600
    • Recruiting
    • Centro Sanitario "Camargo Interior"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: transdiagnostic cognitive-behavioural therapy (TD-CBT); 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); Transdiagnostic cognitive-behavioral therapy (TD-CBT)
Active Comparator: relaxation therapy; 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); Bernstein and Borkovec progressive muscle relaxation (PMR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depressive symptoms: Patient Health Questionnaire - 9 item (PHQ-9)	The PHQ-9 (Kroenke et al., 2001) is the depression module of the PHQ (Díez-Quevedo et al., 2001; Spitzer et al., 1999) that scores the 9 DSM-IV depression criteria in the last two weeks. Is a nine item, self-report scale that ranges from 0 to 27 (higher scores means a worse outcome).	Baseline, immediately after the intervention, and 12 month follow-up
Change in anxiety symptoms: Generalized Anxiety Disorder - 7 item (GAD-7)	The GAD-7 (Spitzer et al., 2006) assesses common anxiety symptoms in the last two weeks. It is composed of seven self-report items ranging from 0 to 21 points. Higher scores means a greater presence of anxiety symptoms.	Baseline, immediately after the intervention, and 12 month follow-up
Change in somatic symptoms: Patient Health Questionnaire - 15 item (PHQ-15)	The PHQ-15 (Kroenke et al., 2002) is the somatization module of the PHQ and scores symptoms present in the past four weeks. The scale is composed of fifteen self-report items, ranging from 0 to 30. Higher scores means a worse outcome.	Baseline, immediately after the intervention, and 12 month follow-up
Change in functioning: Sheehan Disability Scale (SDS)	The SDS (Sheehan et al., 1996) is a five item self-reported scale composed of three main domains (work, family and social functioning) and two optional items (perceived stress and perceived social support). It ranges from 0 to 50, with higher scores indicating a worse outcome.	Baseline, immediately after the intervention, and 12 month follow-up
Change in treatment satisfaction	Posttreatment and 12-month follow-up assessments will also collect an additional question about treatment satisfaction, through a Likert-type question, ranging from 0 to 10.	Immediately after the intervention and 12-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in rumination: Ruminative Responses Scales (brooding subscale) (RRS-B)	The RRS-B (Nolen-Hoeksema & Morrow, 1991) is composed of five self-reported items, ranging from 5 to 20. Higher scores means a worse outcome.	Baseline, immediately after the intervention, and 12-month follow-up
Change in worry: Penn State Worry Questionnaire - Abbreviated (PSWQ-A)	The PSWQ-A (Meyer et al., 1990) measures the pathological worry as an uncontrollable and general state. The scale is composed of eight self-reported items, ranging from 5 to 40. Higher scores means a worse outcome	Baseline, immediately after the intervention, and 12-month follow-up
Change in attentional and interpretative biases: Inventory of Cognitive Activity in Anxiety Disorders (IACTA)	The IACTA was originally developed by Cano-Vindel (2001). It includes subscales that assess distortions according to Eysenck's four-factor theory (Eysenck, 2000). The scale is composed of five self-reported items, ranging from 0 to 20. Higher scores means a worse outcome.	Baseline, immediately after the intervention, and 12-month follow-up
Change in emotion regulation: Cognitive Emotion Regulation Questionnaire (CERQ)	The CERQ-36 (Garnefski et al., 2001) was developed for measuring the specific cognitive emotion regulation strategies that a person uses to face a stressful event (self-blame, acceptance, rumination, positive refocus, refocus on planning, positive reappraisal, putting into perspective, catastrophizing or blaming others). It scores from 1 ("almost never") to 5 ("almost always") how often the participant thinks as described. The 27-item shortened version will be used (Holgado-Tello et al., 2018). Each cognitive strategy is assessed by means of three items, ranging from 3 to 15. Higher scores means a greater use of the strategy.	Baseline, immediately after the intervention, and 12-month follow-up
Change in metacognitive beliefs: Metacognitions Questionnaire (negative beliefs subscale) (MCQ)	The MCQ-NB (Wells & Cartwright-Hatton, 2004) is a short form of the original MCQ (Cartwright-Hatton & Wells, 1997), which measures the beliefs about the own thinking processes. The scale is composed of six self-reported items, ranging from 6 to 24. Higher scores means a worse outcome.	Baseline, immediately after the intervention, and 12-month follow-up
Change in cognitive Distortions in Emotional Disorders (CDTE)	The CDTE (The PsicAP Group, unpublished) measures the frequency of certain cognitive biases. It includes sixteen self-reported items that measure the presence of four factors: sustained attention bias, divided attention bias, magnification interpretational bias, and catastrophization interpretational bias. It ranges from 0 to 4. Higher scores means a greater presence of the cognitive bias.	Baseline, immediately after the intervention, and 12-month follow-up
Change in alliance: Working Alliance Inventory Patient Form (WAI-P) and Group Session Rating Scale (GSRS)	The WAI-P (Andrade-González & Fernández-Liria, 2015) is a thirty-six self-report scale that measure perceived therapeutic alliance. It ranges from 36 to 252 with higher scores indicating better alliance between patient and clinical professional. The GSRS (Duncan & Miller, 2007) is a four self-reported scale that assess alliance to the group. It ranges from 0 to 40, with higher scores indicating better alliance between the patient and the group of therapy.	In therapy sessions number 1, 4 and 7

Collaborators and Investigators

• Sponsor: Instituto de Investigación Marqués de Valdecilla

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: randomized controlled trial; depression; primary care; cognitive behavioral therapy; somatoform disorders; anxiety disorders; emotional disorders; cost-benefit analysis; transdiagnostic therapy; brief psychological treatments
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Mood Disorders
• Other Study ID Numbers: PsicAP-Costs2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No