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

NCT04847310 | Active Not Recruiting

• 1 other identifier: PID2019-107243RB-C22
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of this study is to compare, in cost-effectiveness and cost-utility terms, a brief transdiagnostic cognitive-behavioural therapy in two different modes, individual and group, with the treatment usually administered in primary care (TAU). Participants between 18 and 65 years old and with, according to the pretreatment evaluation, mild to moderate emotional disorders will be randomly allocated to the three clusters. They will be assessed again immediately after treatment and 6 and 12 months later. The study hypotheses expect to find (H1) the individual treatment generally as effective as the group one, whereas (H2) the TAU will be the least effective. (H3) The group therapy is expected to get the best results in terms of cost-effectiveness and (H4) the TAU will get the worst cost-effectiveness results. Furthermore, (H5) it is expected to find these results across the follow-up assessments too.

Conditions

Emotional Disorder; Depression; Somatoform Disorders; Anxiety Disorders

Keywords

transdiagnostic therapy; emotional disorders; primary care; cost-benefit analysis; brief psychological treatments; randomized controlled trial; depression; anxiety disorders; somatoform disorders

Outcome Measures

Primary Outcomes (4)

• Change in depression symptoms: 9-item Patient Health Questionnaire (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 present in the last two weeks from 0 ("not at all") to 3 ("nearly every day"). A score of 10 is usually set as the cut-off point for major depression disorder (MDD): a score of 10-14 indicates minor depression, moderate MDD, or dysthymia; 15-19, moderately severe MDD; and 20-27, severe MDD. This tool has been tested in Spanish primary care centres (McDonald's ω = .89) (Muñoz-Navarro, Cano-Vindel, Medrano et al., 2017), finding 12 as the best cut point for MDD diagnosis (sensitivity of 84% and specificity of 78%) compared with 10 (sensitivity of 95% and specificity of 67%).

  Baseline, immediately after the intervention, and follow-ups (6 and 12 months)

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

  The GAD-7 (Spitzer et al., 2006) assesses common anxiety symptoms in the last two weeks, scoring from 0 ("not at all") to 3 ("nearly every day"). Cut points of 5, 10, and 15 represent mild, moderate, and severe anxiety, respectively. The algorithm sets 8 as the cut point for GAD, however it has been found that a score of 10 is more optimal (Spitzer et al., 2006). We will use the version validated by García-Campayo et al. (2010), that was recently tested in primary care centres (Cronbach's α = .83) (Muñoz-Navarro, Cano-Vindel, Moriana et al., 2017), confirming the score of 10 as the best diagnostic criterion (sensitivity of 87% and specificity of 78%).

  Baseline, immediately after the intervention, and follow-ups (6 and 12 months)

• Change in panic symptoms: Patient Health Questionnaire-Panic Disorder (PHQ-PD)

  The PHQ-PD is the specific panic disorder module of the PHQ and scores each DSM-IV criterion as "yes" or "no" (Wittkampf et al., 2011). Muñoz-Navarro et al. (2016) tested it in Spanish primary care settings and modified the original algorithm to increase the sensitivity for PD diagnosis: the most optimal cut-off point for screening purposes was 5 (the first item \[for panic screening\] and one of the following three, plus four somatic symptoms) (sensitivity of 77% and specificity of 72%).

  Baseline, immediately after the intervention, and follow-ups (6 and 12 months)

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

  The PHQ-15 (Kroenke et al., 2002) is the somatization module of the PHQ. It includes 13 somatic symptoms plus 2 from the PHQ-9 (sleeping problems and fatigue). Scores of 5, 10, and 15 represent low, medium, and high somatic symptom severity, respectively. To screen a somatization disorder, whereas the original algorithm needs of at least a score of 2 in three or more somatic symptoms (sensitivity of 78% and specificity of 71%) (van Ravesteijn et al., 2009), the cut point usually used is 10; nevertheless, since this can be obtained with ten symptoms of mild severity, we decided to join both criteria to screen the disorder. Furthermore, an absence of biological cause is also often required (since PHQ-15 does not distinguish between medically explained and unexplained symptoms) (Kroenke et al., 2002), but the self-administered nature of the PHQ-15 makes difficult to determine this. The PHQ-15 has been validated with Spanish psychiatric outpatients (α = .78) (Ros et al., 2010).

  Baseline, immediately after the intervention, and follow-ups (6 and 12 months)

Secondary Outcomes (10)

• Change in the level of impairment: Sheehan Disability Scale (SDS)

  Baseline, immediately after the intervention, and follow-ups (6 and 12 months)

• Change in general quality of life: World Health Organization Quality of Life Instrument-Brief version (WHOQOL-BREF)

  Baseline, immediately after the intervention, and follow-ups (6 and 12 months)

• Change in ruminative responses: Ruminative Responses Scale (RRS)

  Baseline, immediately after the intervention, and follow-ups (6 and 12 months)

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

  Baseline, immediately after the intervention, and follow-ups (6 and 12 months)

• Change in attentional and interpretational biases: Inventory of Cognitive Activity in Anxiety Disorders (IACTA) and Questionnaire of Cognitive Distortions in Emotional Disorders (CDTE)

  Baseline, immediately after the intervention, and follow-ups (6 and 12 months)

Other Outcomes (2)

• Presence of emotional disorder (inclusion criterion): Patient Health Questionnaire 4 items (PHQ-4)

  Pre-intervention (screening)

• Presence of severe mental disorders (exclusion criterion)

  Pre-intervention (screening)

Study Arms (3)

Group 1

EXPERIMENTAL

Other: Group brief transdiagnostic cognitive-behavioral therapy

Group 2

EXPERIMENTAL

Other: Individual brief transdiagnostic cognitive-behavioral therapy

Group 3

ACTIVE COMPARATOR

Other: Treatment as usual

Interventions

Group brief transdiagnostic cognitive-behavioral therapy OTHER

An adaptation of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) (Barlow et al., 2015) and the IAPT programme (Clark, 2018). It has been developed by Cano-Vindel (González-Blanch et al., 2018) and consists in seven 90-minute sessions, provided by a non-assessor clinical psychologist in 12-16 weeks, with 8-10 participants per group. Sessions are weekly or biweekly, reducing their frequency as the intervention advances. The activities and homework proposed are supported with materials such as theory documents, a CD for progressive muscle relaxation, self-recording sheets, and a therapy web (www.desordenesemocionales.es).

Also known as: Group tCBT

Group 1

Individual brief transdiagnostic cognitive-behavioral therapy OTHER

An adaption of the group therapy, with the same phases. However, since it is an individual intervention, it is more flexible than group one and its contents and duration can be personalized. This intervention consists of a minimum of 6 and a maximum of 8 sessions of 30-60 minutes, provided by a clinical psychologist not involved in the assessments.

Also known as: Individual tCBT

Group 2

Treatment as usual OTHER

Participants in this group will be provided the common primary care treatment by the GP, in a face-to-face consultation that seldom exceeds 10 minutes. TAU usually consists in pharmacological treatment prescribed by the GP, however, it might also consist in practical advice or even non-treatment (Watts et al., 2015). The first consultation will count as part of the recruitment process and, if the patient accepts to participate in the trial, no therapeutic help will be provided to them until they are allocated. Once in the TAU intervention, if the practitioner recommended any psychological treatment as part of it (e.g., referral to specialized care), the participant would be excluded to avoid contamination between clusters. TAU has not a specific amount of sessions; it will finish when the GP considers the patient is recovered.

Also known as: TAU

Group 3

Eligibility Criteria

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

You may qualify if:

• Mild/moderate emotional disorder

You may not qualify if:

• Severe mental disorder (including severe depressive or anxiety disorders, not somatizations)
• High level of impairment
• Recent, severe suicide attempt
• No emotional disorder/Below the instruments cut-off points

Sponsors & Collaborators

• Universidad de Córdoba: lead
• State Research Agency, Spain: collaborator

Study Sites (3)

Unidad de Salud Mental Comunitaria Montilla

Montilla, Córdoba, 14550, Spain

Location

Centro Sanitario "Levante Sur Dr. Manuel Barragán Solís"

Córdoba, 14007, Spain

Location

Centro Sanitario "Carlos Castilla del Pino"

Córdoba, 14011, Spain

Location

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MeSH Terms

Conditions

Depression; Somatoform Disorders; Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Juan Antonio Moriana Elvira, PhD

  Universidad de Córdoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• 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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: Multicenter randomized controlled trial with pre-post measures and follow-ups.

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 19, 2021
• Study Start: September 1, 2021
• Primary Completion: May 1, 2025
• Study Completion: April 1, 2026
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

ES (3)