Condition category
Mental and Behavioural Disorders
Date applied
02/05/2013
Date assigned
20/05/2013
Last edited
20/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Protocol

Plain English Summary

Background and study aims
The strong demand for primary care (PC) services in Spain exceeds the existing resources. Part of this demand is due to the increasing number of anxiety, depression and somatisation disorders that affect the general population. These disorders, commonly known as emotional disorders, are very common in Spanish PC settings, are poorly detected by the physician, rarely receive adequate treatment [if they receive treatment it is mostly pharmacological (treatment with medicinal drugs) instead of psychological treatment], they generate a highly frequent use of PC services, a greater burden than physical diseases and tend to become chronic without treatment. Other countries have successfully put psychological techniques in PC into practice (in the UK, for example, the programme known as Improving Access to Psychological Therapies has obtained very positive results) in order to correctly diagnose and treat emotional disorders. The results obtained in terms of symptoms, quality of life, diagnosis, etc., have been better than the usual treatment that is offered, with no side effects, fewer relapses, and lower costs in the long term. The aim of this study is to test how well a psychological treatment programme for anxiety, depression and somatisation disorders works in PC and to compare the results obtained after seven 90-minute group sessions of a transdiagnostic cognitive behavioral therapy (TD-GCBT) (approximately every to two to four weeks) with the usual treatment offered in Spanish PC services. The group sessions will be made up of one clinical psychologist and about eight participants.

Who can participate?
About 1130 adults, regardless of their age and sex, with an anxiety, depression and/or somatisation disorder (diagnosed with a simple and short questionnaire) will participate in this study. Participation will be voluntary and confidentiality will be guaranteed.

What does the study involve?
Half of the participants in the study will be randomly assigned to receive their usual care and the other half will receive psychological treatment, within the same healthcare centre. Neither the health professional nor the patient will know which treatment will be applied. Psychological assessments will be carried out before and after receiving treatment. The following variables will be assessed: clinical symptoms (anxiety, depression, somatisations), levels of adjustment (work, family, social), quality of life (physical, psychological, social, environmental), emotional and thoughts (worries, beliefs, coping strategies, negative thoughts, etc.), treatment satisfaction, frequent use of services, and psychoactive drug use. After receiving either the usual or the psychological treatment, participants will be followed up at 3, 6 and 12 months.

What are the possible benefits and risks of participating?
The aim of this study will be to maximize benefits and reduce potential harms. Participation will pose no risks different from the typically present when receiving usual treatment.

When is the study starting and how long is it expected to run for?
It will be carried out in 11 primary care centres in Madrid, Valencia, Albacete, Mallorca, Murcia, Vizcaya and Melilla, and may be extended to other centres and cities.

When is the study starting and how long is it expected to run for?
It is expected to start in June 2013 and finish by the end of 2014. The study will be open to participants until recruitment is completed.

Who is funding the study?
Psicofundación (Spanish Foundation for the Promotion, Scientific and Professional Development of Psychology) and the Spanish Ministry of Economy and Competitiveness.

Who is the main contact?
Dr. Antonio Cano-Vindel
canovindel@psi.ucm.es

Trial website

http://www.desordenesemocionales.es/

Contact information

Type

Scientific

Primary contact

Prof Antonio Cano-Vindel

ORCID ID

Contact details

Facultad de Psicologia
Departamento de Psicologia Basica II (Procesos Cognitivos)
buzon 23
Universidad Complutense de Madrid
Madrid
28230
Spain
+34 (0) 60 770 57 40
canovindel@psi.ucm.es

Type

Public

Additional contact

Prof Roger Muñoz Navarro

ORCID ID

http://orcid.org/0000-0002-7064-3699

Contact details

Department of Psychology and Sociology
Faculty of Social and Human Sciences
University of Zaragoza
Teruel
44003
Spain
+34 978618101
rogermnavarro@gmail.com

Additional identifiers

EudraCT number

2013-001955-11

ClinicalTrials.gov number

Protocol/serial number

AP105162012

Study information

Scientific title

Transdiagnostic Cognitive Behavioral Therapy Versus Treatment as Usual in Adult Patients With Emotional Disorders in the Primary Care Setting. The PsicAP Randomized Controlled Trial

Acronym

ED, PC

Study hypothesis

Current study hypothesis as of 19/03/2020:
Our general hypothesis is that the psychological treatment (TD-GCBT) will be more effective and efficient than usual treatment in primary care and that the gains will be maintained at follow-up. The working hypotheses are that if: (a) an evidence-based cognitive-behavioural treatment protocol, transdiagnostic, in group format, is applied considering that EDs are associated with stress, negative emotions, lack of valid information and coping skills, cognitive errors, emotion regulation deficits, and emotional learning through direct conditioning; (b) bearing in mind that this cognitive-emotional process is reversible; (c) the protocol comprises the most efficient cognitive-behavioural techniques that include the following principles: psychoeducation and
cognitive restructuring, relaxation techniques for reducing anxiety, and behavioural skills
training; and (d) we apply this psychological intervention protocol to the experimental group; then, we expect this group to obtain better results in the dependent variables under study than the control group that will receive treatment-as-usual, at post-treatment and follow-up (3, 6 and 12 months).

Previous study hypothesis:
Our general hypothesis is that the psychological (cognitive behavioural) treatment will be more effective and efficient than usual treatment in primary care and that the gains will be maintained at follow-up. The working hypotheses are that if: (a) an evidence-based cognitive-behavioural treatment protocol is applied considering that EDs are associated with stress, negative emotions, lack of valid information and coping skills, cognitive errors, emotion regulation deficits, and emotional learning through direct conditioning; (b) bearing in mind that this cognitive-emotional process is reversible; (c) the protocol comprises the most efficient cognitive-behavioural techniques that include the following principles: psychoeducation and cognitive restructuring, relaxation techniques for reducing anxiety, and behavioural skills training; and (d) we apply this psychological intervention protocol to the experimental group; then, we expect this group to obtain better results in the dependent variables under study than the control group that will receive treatment-as-usual, at post-treatment and follow-up (3, 6 and 12 months).

Ethics approval

Comité Ético de Investigación corporativo de Atención Primaria de la Comunitat Valenciana (Ethics Comittee of Corporative Research in Primary Care in Valencian Department), 14/11/2013, Number: Versión 3, salud 2; fecha 21/02/2013

Study design

Multicentre longitudinal randomised controlled trial with two parallel arms

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Emotional disorders

Intervention

Current interventions as of 19/03/2020:
Experimental group: seven 90-minute group sessions of evidence-based psychological techniques, with a transdiagnostic group cognitive behavioural treatment (TD-GCBT). The manualized protocol will include the following training: psychoeducation (on emotions and emotional disorders) and cognitive bias modification, progressive muscle relaxation, breathing skills, imagination and suggestion of relaxing images, behavioural and social skills, exposure to emotional situations and relapse prevention.

Control group: treatment as usual (basically pharmacological, including muscle relaxants, pain relievers, anti-anxiety and antidepressant medication)

Joint/secondary sponsor details:
Ministerio de Economía y Competitividad, Gobierno de España.
https://sede.micinn.gob.es/csv/
Subdirección General de Proyectos de Investigación
Calle Albacete, 5.
Tel: +34 916037770
E-mail: sgpi.secretaria@mineco.es


Previous interventions:
Experimental group: seven 90-minute group sessions of cognitive behavioural treatment (evidence-based psychological techniques). The manualized protocol will include the following training: psychoeducation (on emotions and emotional disorders) and cognitive bias modification, progressive muscle relaxation, breathing skills, imagination and suggestion of relaxing images, behavioural and social skills, exposure to emotional situations and relapse prevention.

Control group: treatment as usual (basically pharmacological, including muscle relaxants, pain relievers, anti-anxiety and antidepressant medication)

Joint/secondary sponsor details:
Ministerio de Economía y Competitividad, Gobierno de España.
https://sede.micinn.gob.es/csv/
Subdirección General de Proyectos de Investigación
Calle Albacete, 5.
Tel: +34 916037770
E-mail: sgpi.secretaria@mineco.es

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

Current primary outcome measure as of 19/03/2020:
All of the following measures will be assessed at the completion of the 7 session program and at 3, 6, and 12 months follow-up
1. Self-reported emotional symptoms (total anxiety, depression, and somatic scores):
a. Total symptoms measured by the Patient Health Questionnaire (PHQ; Spitzer, Kroenke, & Williams, 1999)
b. Anxiety symptoms measured using GAD-7 (anxiety symptom severity >= 10), with seven items, each of which is scored 0 to 3, providing a 0 to 21 severity score (Spitzer, Kroenke, Williams, & Lowe, 2006)
c. Depression symptoms measured using PHQ-9 (depression >= 10), with nine items, each of which is scored 0 to 3, providing a 0 to 27 severity score (Kroenke, Spitzer, & Williams, 2001)
d. Somatic symptoms measured using PHQ-15 (somatic symptom severity >= 5), with 15 items, each of which is scored 0 to 2, providing a 0 to 30 severity score (van Ravesteijn et al., 2009)
2. Percentage of cases with probable emotional disorder according to DSM-IV diagnostic criteria, using the PHQ subscales (Spitzer, Kroenke, & Williams, 1999):
a. Generalized Anxiety Disorder measured using GAD-7 (diagnostic algorithm >= 8) where a score of at least 2 on the first question, plus three more items is given (Spitzer, Kroenke, Williams, & Lowe, 2006)
b. Major Depression Disorder measured using PHQ-9 (diagnostic algorithm >= 10), where at least one of the two first items is rated with a 2 (more than half of the days) or a 3 (most days) and four of the remaining items are also rated with a score of 2 or 3 (with the exception of item 9, in which a rating of 1 is sufficient for diagnosis) (Kroenke, Spitzer, & Williams, 2001)
c. Somatization Disorder measured using PHQ-15 (diagnostic algorithm >= 6) where 2 points are scored on at least five of the first 13 symptoms (van Ravesteijn et al., 2009)
d. Panic Disorder measured using PHQ-PD (diagnostic algorithm = modified) where an affirmative response is given to the first screening item, to one of the three items on the next scale, and to four or more items of the somatic symptoms (Muñoz-Navarro et al., 2017)


Previous primary outcome measure:
When comparing the pre- and post-treatment measures, the experimental group but not the control group will show a decrease in the following measures:
1. Self-reported emotional symptoms (total anxiety, depression, and somatic scores as measured by the Patient Health Questionnaire (PHQ); Spitzer, Kroenke, & Williams, 1999)
2. Associated cognitive-emotional factors, such as ruminations (measured using the 5-item Brooding Subscale of the Ruminative Response Scale (RRS) with response options from 1 (never) to 4 (always); Nolen-Hoeksema & Morrow, 1991)
3. Pathological worry (using 8 items from the Penn State Worry Questionnaire (PSWQ) with response options from 1 (not at all typical) to 5 (very typical); Meyer, Miller, Metzger & Borkovec, 1990)
4. Attentional and interpretive biases (using 5 items from the Inventory of Cognitive Activity in Anxiety Disorders [IACTA], with response options from 0 [almost never] to 4 [almost always]; Cano-Vindel & Miguel-Tobal, 2004)
6. Emotion regulation (using the 10-item Emotion Regulation Questionnaire (ERQ) with response options from 1 (totally disagree) to 7 (totally agree); Gross & John, 2003)
7. Negative metacognitions (using the 6-item Negative Metacognitions Subscale of the Metacognitions Questionnaire [MCQ-30], with response options from 1 [totally disagree] to 4 [totally agree] Wells & Cartwright-Hatton, 2004)
8. Percentage of cases with probable ED according to DSM-IV diagnostic criteria [using the PHQ subscales: GAD-7 (anxiety symptom severity >= 10)], with seven items, each of which is scored 0 to 3, providing a 0 to 21 severity score (Spitzer, Kroenke, Williams, & Lowe, 2006); PHQ-9 (depression >= 10), with nine items, each of which is scored 0 to 3, providing a 0 to 27 severity score (Kroenke, Spitzer, & Williams, 2001); PHQ-15 (somatic symptom severity >= 5), with 15 items, each of which is scored 0 to 2, providing a 0 to 30 severity score (van Ravesteijn et al., 2009), PHQ-PD (panic disorder >= 8), including the first 4 items (Wittkampf, Baas, van Weert, Lucassen, & Schene, 2011)
9. Their levels of work, family and social impairment (using the Sheehan Disability Scale (SDS) which is a 10-point visual analog scale that uses spatiovisual, numeric and verbal descriptive anchors simultaneously; Sheehan, Harnett-Sheehan, & Raj, 1996)
10. An increase in physical, psychological, social, and environmental quality of life (as measured by the different WHOQOL-BREF scales, which includes four types of 5-point Likert interval scales that inquire ‘how much’, ‘how completely’, how often’, ‘how good’ or ‘how satisfied’ the respondent felt in the last 2 weeks; Rocha, Power, Bushnell, & Fleck, 2012)
These gains will be maintained at 3, 6, and 12 months follow-up. In addition, the experimental group will report higher treatment satisfaction than the control group.

Secondary outcome measures

Current secondary outcome measures as of 19/03/2020:
All of the following measures will be assessed at the completion of the 7 session program and at 3, 6, and 12 months follow-up
1. Levels of work, family and social impairment measured using the Sheehan Disability Scale (SDS) which is a 10-point visual analog scale that uses spatiovisual, numeric and verbal descriptive anchors simultaneously (Sheehan, Harnett-Sheehan, & Raj, 1996)
2. Increase in physical, psychological, social, and environmental quality of life measured by the different World Health Organization Quality of Life Instruments (WHOQOL-BREF) scales, which includes four types of 5-point Likert interval scales that inquire: how much; how completely; how often; how good; or how satisfied the respondent felt in the last 2 weeks (Rocha, Power, Bushnell, & Fleck, 2012).
3. Associated cognitive-emotional factors, such as:
a. Ruminations measured using the 5-item Brooding Subscale of the Ruminative Response Scale (RRS) with response options from 1 (never) to 4 (always) (Nolen-Hoeksema & Morrow, 1991)
b. Pathological worry measured using 8 items from the Penn State Worry Questionnaire-Abbreviated (PSWQ-A) with response options from 1 (not at all typical) to 5 (very typical) (Meyer, Miller, Metzger & Borkovec, 1990)
c. Attentional and interpretive biases measured using 5 items from the Inventory of Cognitive Activity in Anxiety Disorders for panic disorders (IACTA-PD), with response options from 0 (almost never) to 4 (almost always) (Cano-Vindel & Miguel-Tobal, 2004)
d. Emotion regulation measured using the 10-item Emotion Regulation Questionnaire (ERQ) with response options from 1 (totally disagree) to 7 (totally agree) (Gross & John, 2003)
e. Negative metacognitions measured using the 6-item Negative Metacognitions Subscale of the Metacognitions Questionnaire (MCQ-30), with response options from 1 (totally disagree) to 4 (totally agree) (Wells & Cartwright-Hatton, 2004)
4. Cost-effectiveness and cost-utility measures determined from information obtained from patient self-reports and the objective data collected by the healthcare information systems at the different centres
5. Treatment Satisfaction determined by patient self-reports

Previous secondary outcome measures:
The experimental group but not the control group will have reduced the frequency of PC visits and psychoactive drug use (as well as other healthcare costs) at post-treatment and 6-month follow-up. This will result in better, more cost-effective services than the ones offered to the control group with usual care. This information will be obtained from patients’ self-reports and the objective data collected by the healthcare information systems at the different centres.

Overall trial start date

30/06/2013

Overall trial end date

31/07/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Any adult patient seeking treatment, regardless of his/her age and sex, with a probable anxiety, mood and/or somatisation disorder (diagnosed with the Patient Health Questionnaire) will be offered to participate in this study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1126 eligible patients. 563 participants will be randomly assigned to each group.

Participant exclusion criteria

1. Patients with severe mental disorders will be excluded (e.g., bipolar disorder, personality disorder)
2. A history of frequent or recent suicide attempt(s)
3. High level of disability

Recruitment start date

30/06/2013

Recruitment end date

31/07/2018

Locations

Countries of recruitment

Spain

Trial participating centre

Facultad de Psicologia
Madrid
28230
Spain

Sponsor information

Organisation

Spanish Foundation for the Promotion and Development of Scientific and Professional Psychology (Spain)

Sponsor details

Psicofundación. Fundación Española para Promoción
Desarrollo Científico y Profesional de la Psicología
Calle Conde de Peñalver
45
Planta 5 Puerta Izq.
Madrid
28006
Spain
+34 (0) 91 444 90 20
infocop@cop.es

Sponsor type

Other

Website

http://www.psicofundacion.es/

Funders

Funder type

Government

Funder name

Psicofundación. Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicología (Spain), ref: AP105162012

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ministry of Science and Innovation, Government of Spain (Ministerio de Economía y Competitividad, Gobierno de España) (Spain), ref: PSI2012-36589

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

As of March 2020, a manuscript of the major results primary (symptoms) and secondary outcomes and long-term has been prepared for publication. (added 19/03/2020)

Intention to publish date

01/06/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

2016 protocol in https://www.ncbi.nlm.nih.gov/pubmed/28011446

Publication citations

Additional files

Editorial Notes

20/04/2020: The following changes have been made: 1. The public title has been changed from "A pilot study to treat Emotional Disorders (ED) in Primary Care (PC) with evidence-based psychological techniques" to "A pilot project to treat emotional disorders in Primary Care with evidence-based psychological techniques: a randomized controlled trial". 2. The scientific title has been changed from "A pilot study to treat anxiety, depression and somatisations in Spanish primary care services with psychological techniques in seven group sessions of transdiagnostic cognitive-behavioral therapy (TD-GCBT): comparison of results using psychological treatment versus usual primary care treatment, with follow-up assessments after 3, 6 and 12 months - a randomised controlled trial." to "Transdiagnostic Cognitive Behavioral Therapy Versus Treatment as Usual in Adult Patients With Emotional Disorders in the Primary Care Setting. The PsicAP Randomized Controlled Trial". 3. A public contact has been added. 19/03/2020: The following changes have been made: 1. The scientific title has been changed from "A pilot study to treat anxiety, depression and somatisations in Spanish primary care services with psychological techniques in seven group sessions: comparison of results using psychological treatment versus usual primary care treatment, with follow-up assessments after 3, 6 and 12 months - a randomised controlled trial" to "A pilot study to treat anxiety, depression and somatisations in Spanish primary care services with psychological techniques in seven group sessions of transdiagnostic cognitive-behavioral therapy (TD-GCBT): comparison of results using psychological treatment versus usual primary care treatment, with follow-up assessments after 3, 6 and 12 months - a randomised controlled trial.". 2. The study hypothesis has been updated. 3. The interventions have been updated. 4. The recruitment end date has been changed from 31/12/2014 to 31/07/2018. 5. The overall trial end date has been changed from 31/12/2014 to 31/07/2019. 6. The intention to publish date has been added. 7. The primary outcome measure has been updated. 8. The secondary outcome measures have been updated. 9. The plain English summary has been updated to reflect the changes above. 10. The publication and dissemination plan has been added. 29/12/2016: Publication reference added.