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Emotional DisorderPsicAP-CostsNCT04847310

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

A study testing Group brief transdiagnostic cognitive-behavioral therapy, Individual brief transdiagnostic cognitive-behavioral therapy and Treatment as usual in people with Emotional Disorder and Depression, run by Universidad de Córdoba at 3 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Group brief transdiagnostic cognitive-behavioral therapy, Individual brief transdiagnostic cognitive-behavioral therapy and Treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
3 sitesSpain
Study dates
1 Sep 2021to Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Mild/moderate emotional disorder

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Centro Sanitario "Levante Sur Dr. Manuel Barragán Solís"

    Córdoba, 14007

  • Centro Sanitario "Carlos Castilla del Pino"

    Córdoba, 14011

  • Unidad de Salud Mental Comunitaria Montilla

    Montilla, Córdoba, 14550

Other trials in Spain

About this study

Official title: Cost-effectiveness and Cost-Utility Evaluation of the Individual vs. Group Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care (PsicAP-Costs)

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.

Being tested
Group brief transdiagnostic cognitive-behavioral therapy, Individual brief transdiagnostic cognitive-behavioral therapy, Treatment as usual
Keywords
transdiagnostic therapy, emotional disorders, primary care, cost-benefit analysis, brief psychological treatments, randomized controlled trial, depression, anxiety disorders, somatoform disorders
Medical subject headings
Depression, Somatoform Disorders, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group brief transdiagnostic cognitive-behavioral therapyOther

    Also called Group tCBT

    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).

  • Individual brief transdiagnostic cognitive-behavioral therapyOther

    Also called Individual tCBT

    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.

  • Treatment as usualOther

    Also called TAU

    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.

Study groups in NCT04847310
Study groupRoleWhat they receive
Group 1ExperimentalNot described
Receives: Other: Group brief transdiagnostic cognitive-behavioral therapy
Group 2ExperimentalNot described
Receives: Other: Individual brief transdiagnostic cognitive-behavioral therapy
Group 3Active comparatorNot described
Receives: Other: Treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%).

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

  2. 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%).

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

  3. 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%).

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

  4. 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).

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

Secondary outcomes (10)

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

    The SDS (Sheehan et al., 1996) is a self-administered test that measures the subjective symptom-related impairment with five 11-point Likert items. The three first items rate key areas in the past month: work, social life/leisure activities, and family life/home responsibilities. It has two additional items to assess stress level and perceived social support in the past week. We will use the Spanish version developed by Bobes et al. (1999), that has shown good properties with primary care population (α = .83) (Luciano et al., 2010). One, four, and seven are the cut points for mild, moderate, and high disability, respectively. A total score of 25 or more indicates a general high disability, and the patient will be asked by a clinical psychologist to confirm: 'Are you on sick leave?', 'Can you do the housework?', and 'Can you engage socially?' (one question per area).

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

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

    Psychological, physical, social, and environmental domains will be assessed through the twenty-six 5-point Likert items of the WHOQOL-BREF (The WHOQOL Group, 1998b), the abbreviated version of the 100-item WHOQOL (WHOQOL-100) (The WHOQOL Group, 1998a). The more the participant scores, the better quality of life they have. The WHOQOL has been validated with Spanish population (Lucas-Carrasco, 2012; Rocha et al., 2012) and has shown good psychometric properties: α > .7 in psychological, physical, and environmental domains, though social domain's internal consistency varies from .58 (Rocha et al., 2012) to .75 (Lucas-Carrasco, 2012).

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

  3. Change in ruminative responses: Ruminative Responses Scale (RRS)

    The RRS (Nolen-Hoeksema \& Morrow, 1991) was originally developed to measure the ruminative responses to depressed mood. It has been validated with Spanish population (Hervás, 2008), however, only the 5-item 'brooding' factor subscale (RRS-B) will be used in this trial (α = .79) (Muñoz-Navarro et al., 2021). The RRS-B scores from 1 ("almost never") to 4 ("almost always") how often the participant thinks as it is described in each item when they are discouraged, sad or depressed.

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

  4. Change in worry: Penn State Worry Questionnaire (PSWQ)

    The PSWQ (Meyer et al., 1990) measures the pathological worry as an uncontrollable and general state (i.e., as a GAD feature). It has been validated in Spain (Sandín et al., 2009) and, in this study, it will be used an 8-item abbreviated version (PSWQ-A) (Crittendon \& Hopko, 2006) that has already showed good properties in primary care (α = .9) (Muñoz-Navarro et al., 2021). The PSWQ-A items rate how much worries affect the person from 1 ("not at all typical of me") to 5 ("very typical of me").

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

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

    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 abbreviated panic version (IACTA-PB; α = .87) (Muñoz-Navarro et al., 2021) will be used to measure attentional biases. It specifically scores from 0 ("almost never") to 4 ("almost always") how often the participant has certain cognitive distortions.

    The Questionnaire of Cognitive Distortions in Emotional Disorders (CDTE) (The PsicAP Group, unpublished) scores from 0 ("almost never") to 4 ("almost always") the frequency of certain cognitive biases in the main EDs (MDD, GAD, PD, and somatization disorder). It includes 16 items that measure the presence of four factors: sustained attention bias (α = .96), divided attention bias (α = .95), magnification interpretational bias (α = .94), and catastrophization interpretational bias (α = .96), with high levels of discriminant validity among the four EDs (ROC values > .8).

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

  6. Change in emotion regulation strategies: 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. It scores from 1 ("almost never") to 5 ("almost always") how often the participant thinks as described. The CERQ has been validated with Spanish population (Domínguez-Sánchez et al., 2013) and the 27-item shortened version (Holgado-Tello et al., 2018) will be used (α values range from .72 ['acceptance'] to .88 ['positive refocus']).

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

  7. Change in metacognitions: 30-item Metacognitions Questionnaire (MCQ-30)

    The MCQ-30 (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. It has been validated with Spanish population (Ramos-Cejudo et al., 2013) and, in the current trial, only the 6-item 'negative beliefs' (about uncontrollability/danger) subscale (MCQ-NB; α = .82) will be used (Muñoz-Navarro et al., 2021). It scores from 1 ("totally disagree") to 4 ("totally agree") how the patient agrees with the sentences written.

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

  8. Sociodemographic and medical data, and treatment satisfaction

    An ad hoc questionnaire will be used to collect sociodemographic (gender, age, civil status, educative level, employment situation, and income level) and ED-related medical data (public and private health care consultations, accidents, medical tests, and sick leaves in the past 3 months; psychotropic drugs or other medication, and their posology), and it includes an additional question about treatment satisfaction (only at post-treatment and follow-ups). Medical records will be also consulted to complete the information (for privacy reasons, only strictly necessary data will be collected).

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

  9. Cost and utility data

    The medical data collected will be used for cost calculations too. In addition, cost-utility will be measured through the European Quality of Life Scale (EuroQoL, EQ) (The EuroQol Group, 1990). 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 calculate the quality-adjusted life years (QALYs). The EQ-5D-5L measures five domains of health-related quality of life (mobility, self-care, daily activities, pain/unease, and anxiety/depression) through 5 severity levels ("no problems", "slight problems", "moderate problems", "severe problems", and "extreme problems"), being able to stablish up to 3125 different health states, each of which can be represented through an index value that reflects the health state quality contextualized in the person's country/region. It also includes a visual analogue scale (VAS) that scores from 0 to 100 the current subjective, general health state.

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

  10. Presence of eating disorders or alcohol abuse (exclusion criterion)

    The PHQ also lets to measure the presence of other mental disorders. The Spanish version (Díez-Quevedo et al., 2001) detects eating disorders, such as bulimia nervosa or binge eating disorder, with a sensitivity of 92% and a specificity of 98%; and alcohol abuse with a sensitivity of 76% and a specificity of 99%. Affirmative answers to items 6a to 6c and 8 indicate bulimia nervosa; if item 8 were answered negatively (or unanswered), it would point out a binge eating disorder. An affirmative answer to any of the items 10a to 10e would indicate alcohol abuse. In any of these cases the patient would be interviewed by a clinical psychologist to confirm a possible diagnosis of eating, alcohol or personality disorder.

    Measured: Pre-intervention (screening)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2021
  2. Study start1 Sep 2021
  3. Primary completionMay 2025 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter randomized controlled trial with pre-post measures and follow-ups.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04847310
Sponsor's protocol ID
PID2019-107243RB-C22
Acronym
PsicAP-Costs
Status last verified
Apr 2024
First submitted
9 Apr 2021
Last updated
22 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Badia X, Roset M, Montserrat S, Herdman M, Segura A. [The Spanish version of EuroQol: a description and its applications. European Quality of Life scale]. Med Clin (Barc). 1999;112 Suppl 1:79-85. Spanish.

    PubMed 10618804

  • Barlow DH, Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Allen LB, et al. Protocolo Unificado para el Tratamiento Transdiagnóstico de los Trastornos Emocionales [Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: Therapist Guide and Patient Guide]. 1st ed. Alianza; 2015.

  • Bobes J, Badia X, Luque A, Garcia M, Gonzalez MP, Dal-Re R. [Validation of the Spanish version of the Liebowitz social anxiety scale, social anxiety and distress scale and Sheehan disability inventory for the evaluation of social phobia]. Med Clin (Barc). 1999 Apr 24;112(14):530-8. Spanish.

    PubMed 10363239

  • Cano-Vindel A. [Inventory of Cognitive Activity in Anxiety Disorders (IACTA)]. Unpublished; 2001.

  • Cano-Vindel A, Munoz-Navarro R, Medrano LA, Ruiz-Rodriguez P, Gonzalez-Blanch C, Gomez-Castillo MD, Capafons A, Chacon F, Santolaya F; PsicAP Research Group. A computerized version of the Patient Health Questionnaire-4 as an ultra-brief screening tool to detect emotional disorders in primary care. J Affect Disord. 2018 Jul;234:247-255. doi: 10.1016/j.jad.2018.01.030. Epub 2018 Feb 16.

    PubMed 29549826

  • Cartwright-Hatton S, Wells A. Beliefs about worry and intrusions: the Meta-Cognitions Questionnaire and its correlates. J Anxiety Disord. 1997 May-Jun;11(3):279-96. doi: 10.1016/s0887-6185(97)00011-x.

    PubMed 9220301

  • Clark DM. Realizing the Mass Public Benefit of Evidence-Based Psychological Therapies: The IAPT Program. Annu Rev Clin Psychol. 2018 May 7;14:159-183. doi: 10.1146/annurev-clinpsy-050817-084833. Epub 2018 Jan 19.

    PubMed 29350997

  • Crittendon J, Hopko DR. Assessing worry in older and younger adults: Psychometric properties of an abbreviated Penn State Worry Questionnaire (PSWQ-A). J Anxiety Disord. 2006;20(8):1036-54. doi: 10.1016/j.janxdis.2005.11.006. Epub 2006 Jan 4.

    PubMed 16387472

  • Diez-Quevedo C, Rangil T, Sanchez-Planell L, Kroenke K, Spitzer RL. Validation and utility of the patient health questionnaire in diagnosing mental disorders in 1003 general hospital Spanish inpatients. Psychosom Med. 2001 Jul-Aug;63(4):679-86. doi: 10.1097/00006842-200107000-00021.

    PubMed 11485122

  • Dominguez-Sanchez FJ, Lasa-Aristu A, Amor PJ, Holgado-Tello FP. Psychometric properties of the Spanish version of the Cognitive Emotion Regulation Questionnaire. Assessment. 2013 Apr;20(2):253-61. doi: 10.1177/1073191110397274. Epub 2011 Apr 5.

    PubMed 21467092

  • Eysenck MW. A cognitive approach to trait anxiety. Eur J Pers. 2000 Sep;14(5):463-76

  • First MB, Spitzer RL, Gibbon M, Williams JBW. Entrevista Clínica Estructurada para los Trastornos del Eje I del DSM-IV. Barcelona: Masson; 1999.

  • Garcia-Campayo J, Zamorano E, Ruiz MA, Pardo A, Perez-Paramo M, Lopez-Gomez V, Freire O, Rejas J. Cultural adaptation into Spanish of the generalized anxiety disorder-7 (GAD-7) scale as a screening tool. Health Qual Life Outcomes. 2010 Jan 20;8:8. doi: 10.1186/1477-7525-8-8.

    PubMed 20089179

  • Garnefski N, Kraaij V, Spinhoven P. Negative life events, cognitive emotion regulation and emotional problems. Pers Individ Dif. 2001;30(8):1311-27.

  • González-Blanch C, Umaran-Alfageme O, Cordero-Andrés P, Muñoz-Navarro R, Ruiz-Rodríguez P, Medrano LA, et al. Tratamiento psicológico de los trastornos emocionales en Atención Primaria: el manual de tratamiento transdiagnóstico del estudio PsicAP. Ansiedad y Estrés. 2018;24(1).

Questions about this trial

What is this clinical trial studying?

A study testing Group brief transdiagnostic cognitive-behavioral therapy, Individual brief transdiagnostic cognitive-behavioral therapy and Treatment as usual in people with Emotional Disorder and Depression, run by Universidad de Córdoba at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in depression symptoms: 9-item Patient Health Questionnaire (PHQ-9) (time frame: Baseline, immediately after the intervention, and follow-ups (6 and 12 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04847310, which also lists 46 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.

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