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

Primary Purpose

Emotional Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Transdiagnostic cognitive-behavioral therapy (TD-CBT)
Bernstein and Borkovec progressive muscle relaxation (PMR)
Sponsored by
Instituto de Investigación Marqués de Valdecilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Emotional Disorder focused on measuring transdiagnostic therapy, emotional disorders, primary care, cost-benefit analysis, brief psychological treatments, cognitive behavioral therapy, randomized controlled trial, depression, anxiety disorders, somatoform disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro Sanitario "Sardinero"Recruiting
  • Centro Sanitario "Dávila"Recruiting
  • Centro Sanitario "Camargo Costa"Recruiting
  • Centro Sanitario "Camargo Interior"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

transdiagnostic cognitive-behavioural therapy (TD-CBT)

relaxation therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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).
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.
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.
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.
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.

Full Information

First Posted
January 25, 2022
Last Updated
May 19, 2022
Sponsor
Instituto de Investigación Marqués de Valdecilla
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1. Study Identification

Unique Protocol Identification Number
NCT05314920
Brief Title
Cost-effectiveness of a Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care
Acronym
PsicAP-Costs2
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Marqués de Valdecilla

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter randomized controlled trial with pre-post measures and 12-month follow-up.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transdiagnostic cognitive-behavioural therapy (TD-CBT)
Arm Type
Experimental
Arm Description
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.
Arm Title
relaxation therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Transdiagnostic cognitive-behavioral therapy (TD-CBT)
Intervention Description
Transdiagnostic cognitive-behavioral therapy (TD-CBT)
Intervention Type
Behavioral
Intervention Name(s)
Bernstein and Borkovec progressive muscle relaxation (PMR)
Intervention Description
Bernstein and Borkovec progressive muscle relaxation (PMR)
Primary Outcome Measure Information:
Title
Change in cost-effectiveness data
Description
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).
Time Frame
Baseline, immediately after the intervention, and 12-month follow-up
Title
Change in cost-utility data
Description
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).
Time Frame
Baseline, immediately after the intervention, and 12 month follow-up
Secondary Outcome Measure Information:
Title
Change in depressive symptoms: Patient Health Questionnaire - 9 item (PHQ-9)
Description
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).
Time Frame
Baseline, immediately after the intervention, and 12 month follow-up
Title
Change in anxiety symptoms: Generalized Anxiety Disorder - 7 item (GAD-7)
Description
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.
Time Frame
Baseline, immediately after the intervention, and 12 month follow-up
Title
Change in somatic symptoms: Patient Health Questionnaire - 15 item (PHQ-15)
Description
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.
Time Frame
Baseline, immediately after the intervention, and 12 month follow-up
Title
Change in functioning: Sheehan Disability Scale (SDS)
Description
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.
Time Frame
Baseline, immediately after the intervention, and 12 month follow-up
Title
Change in treatment satisfaction
Description
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.
Time Frame
Immediately after the intervention and 12-month follow-up
Other Pre-specified Outcome Measures:
Title
Change in rumination: Ruminative Responses Scales (brooding subscale) (RRS-B)
Description
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.
Time Frame
Baseline, immediately after the intervention, and 12-month follow-up
Title
Change in worry: Penn State Worry Questionnaire - Abbreviated (PSWQ-A)
Description
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
Time Frame
Baseline, immediately after the intervention, and 12-month follow-up
Title
Change in attentional and interpretative biases: Inventory of Cognitive Activity in Anxiety Disorders (IACTA)
Description
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.
Time Frame
Baseline, immediately after the intervention, and 12-month follow-up
Title
Change in emotion regulation: Cognitive Emotion Regulation Questionnaire (CERQ)
Description
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.
Time Frame
Baseline, immediately after the intervention, and 12-month follow-up
Title
Change in metacognitive beliefs: Metacognitions Questionnaire (negative beliefs subscale) (MCQ)
Description
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.
Time Frame
Baseline, immediately after the intervention, and 12-month follow-up
Title
Change in cognitive Distortions in Emotional Disorders (CDTE)
Description
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.
Time Frame
Baseline, immediately after the intervention, and 12-month follow-up
Title
Change in alliance: Working Alliance Inventory Patient Form (WAI-P) and Group Session Rating Scale (GSRS)
Description
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.
Time Frame
In therapy sessions number 1, 4 and 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
César González-Blanch Bosch, PhD
Phone
+34-942-202537
Email
cesar.gonzalezblanch@scsalud.es
Facility Information:
Facility Name
Centro Sanitario "Sardinero"
City
Santander
ZIP/Postal Code
39005
Country
Spain
Individual Site Status
Recruiting
Facility Name
Centro Sanitario "Dávila"
City
Santander
ZIP/Postal Code
39006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Centro Sanitario "Camargo Costa"
City
Santander
ZIP/Postal Code
39600
Country
Spain
Individual Site Status
Recruiting
Facility Name
Centro Sanitario "Camargo Interior"
City
Santander
ZIP/Postal Code
39600
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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