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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Emotional Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Transdiagnostic cognitive-behavioral therapy (TD-CBT)

Intervention Type BEHAVIORAL

Transdiagnostic cognitive-behavioral therapy (TD-CBT)

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.

Group Type ACTIVE_COMPARATOR

Bernstein and Borkovec progressive muscle relaxation (PMR)

Intervention Type BEHAVIORAL

Bernstein and Borkovec progressive muscle relaxation (PMR)

Interventions

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Transdiagnostic cognitive-behavioral therapy (TD-CBT)

Intervention Type BEHAVIORAL

Bernstein and Borkovec progressive muscle relaxation (PMR)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No