Background
Introduction
Methods/Design
Study design
Sample size
Study population, recruitment and eligibility criteria
Inclusion criteria | Exclusion criteria |
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Minimal age of 18 years | Suffering from Schizophrenia, bipolar disorder, or alcohol and/or substance dependence disorder |
Meeting the DSM-IV diagnostic criteria for ED | High risk of suicide |
Ability to understand and read Spanish | Medical disease/condition that prevents the participant from carrying out the psychological treatment |
Access to Internet at home and having an email address | Receiving another psychological treatment during the study |
Providing online informed consent | An increase and/or change in the pharmacological treatment (in the case of receiving) during the study period |
Ethics
Interventions
Transdiagnostic Internet-based protocol (TIBP)
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M1. Emotional disorders and emotion regulation. The purpose of this module is to provide information about the central role of emotion regulation in emotional disorders. Brief descriptions of the program modules, as well as videos with examples of people suffering from different ED, are also presented.
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M2. Motivation for change. The objective of this module is to enhance motivation for change by recognizing that attitudes towards change can be ambivalent and that motivation fluctuates. The main objective is to analyze the advantages and disadvantages of changing, emphasize the importance of being motivated, and highlight the importance of establishing significant life goals.
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M3. Understanding the role of emotions. This module provides information about the adaptive roles and functions of emotions. It also shows the three-component model of emotions.
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M4. The acceptance of emotional experiences. This module focuses on the awareness and role of acceptance of emotional experiences, as well as their importance in the treatment.
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M5. Practicing acceptance. The objective of this module is to continue to learn about the acceptance of emotional experiences and increase awareness of physical sensations, thoughts, emotions, and daily activities.
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M6. Learning to be flexible. This module teaches participants to be more cognitively flexible in order to see life situations from different perspectives, showing the importance of maladaptive ways of thinking and learning how to identify them in the maintenance of emotional disorders.
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M7. Practicing cognitive flexibility. This module aims to teach the patients how to modify maladaptive ways of thinking. It also provides information about intrusive thoughts and how to deal with them.
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M8. Emotional avoidance. The aim is to teach the patients emotion avoidance strategies that contribute to the maintenance of emotional disorders.
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M9. Emotion Driven Behaviors (EDBs). The aim is for patients to learn the concept of EDBs and replace their own maladaptive EDBs with other more adaptive behaviors.
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M10. Accepting and facing physical sensations. The objectives are to teach the patients the role of physical sensations in their emotional response and train them in interoceptive exposure, in order to increase tolerance and promote habituation to physical sensations.
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M11. Facing emotions in the contexts where they occur. This module aims to increase tolerance to emotions and reduce avoidance behavior. The purpose is to construct exposure hierarchies to help patients to begin to face the avoided situations that contribute to the maintenance of the problem.
Transdiagnostic Internet-based protocol + positive affect component (TIBP + PA)
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M12. Learning to move on. This module focuses on the role of behavioral activation. The aim is to teach the importance of ‘moving on’ in acquiring a proper level of activity and involvement in life. It motivates the patient to get involved in meaningful activities and become engaged in his/her life.
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M13. Learning to enjoy. This module helps the patient to see the importance of positive emotions and teaches procedures that generate positive experiences, promoting involvement in pleasant and significant activities and contact with others. This module involves enjoying positive experiences and “savoring” positive aspects of life in order to enhance wellbeing.
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M14. Learning to live. This module takes a further step in enhancing PA, understanding the importance of identifying the individual’s own psychological strengths, and selecting and carrying out meaningful activities linked to values and goals in life. This module provides strategies to achieve psychological well-being and resilience. The aim is to improve the individual’ abilities and live a life full of purpose and meaning.
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M15. Living and learning. This module focuses on developing an action plan to boost the individual’s psychological strengths. It focuses on the importance of developing and enhancing one’s own strengths and starting to work for life and the future.
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M16. Relapse prevention (this module is the same for both conditions: (TIBP) and (TIBP + PA). It aims to strengthen the strategies learned throughout the program, schedule future practice, and teach how to identify and cope with future high- risk situations.
Adaptation to the web
Support
Measures
Diagnostic interview
Primary outcomes measures
Secondary outcomes measures
Diagnosis-specific measures
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OCD: Obsessive-Compulsive Inventory-Revised (OCI-R) [81]. The OCI-R is a short scale made up of 18 items rated from 1 to 4 to assess obsessive-compulsive symptoms. The OCI-R yields six subscales: washing, checking, ordering, obsessing, hoarding, and neutralizing. The OCI-R has good internal consistency (α = .81 to .93), good to excellent test-retest reliability (α = .57 to .91), good convergent validity, and a solid factor structure. The Spanish version of the OCI-R has been found to be good (α = .86) [82].
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PD/AG: Self-Reported Panic Disorder Severity Scale (PDSS-SR) [83]. The PDSS-SR is a 7-item self-report measure of panic disorder severity. This scale assesses panic attack frequency, distress during panic attacks, severity of anticipatory anxiety, fear and avoidance of agoraphobic situations, fear and avoidance of physical sensations, and work and social impairment. The scale has shown excellent reliability (α = .917), test-retest reliability (ICC = .81), and sensitivity to change. The psychometric analysis of the Spanish version showed excellent internal consistency (α = .85), good test-retest reliability, and adequate convergent validity [82].
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GAD: Penn State Worry Questionnaire (PSWQ) [84]. It is a questionnaire that evaluates symptoms related to GAD. The PSWQ is a 16-item self-report questionnaire that assesses the tendency to worry, as well as the intensity of the worry characteristic of GAD as an uncontrollable, generalized, and excessive experience. The PSWQ has demonstrated good internal consistency ranging from .91 to .95, and good validity and test-retest reliability. The Spanish version of the scale showed an internal consistency of .90 and a test-retest reliability of .82, as well as adequate convergent and discriminant validity [85].
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SAD: Social Interaction Anxiety Scale (SIAS) [86]. This scale is a 20-item self-report measure rated on a 5-point scale ranging from 0 (not at all characteristic or true of me) to 4 (extremely characteristic of me). It assesses cognitive, affective, and behavioral reactions in interactive social situations (symptoms related to social phobia). The SIAS has high internal consistency (α = .88 to .94) and good test-retest and discriminant reliability, as well as adequate construct validity. The Spanish validation of the scale showed adequate internal consistency [87].
Personality measures
Quality of life
Suicidal ideation
Post-module measures
Expectation of treatment scale and opinion of treatment scale.
Measure | Aim | Time of assessment |
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MINI Neuropsychiatric Interview | Diagnosis | BL, Post-T and FU |
PANAS | Positive and negative affect | Post-T and Post-module |
BDI-II | Severity of depression | BL, Post-T and FU |
BAI | Severity of anxiety | BL, Post-T and FU |
OCI-R | Severity of OCD symptoms | BL, Post-T and FU |
PDSS-SR | Severity of PD and agoraphobia symptoms | BL, Post-T and FU |
PSWQ | Severity of GAD symptoms | BL, Post-T and FU |
SIAS | Severity of SAD symptoms | BL, Post-T and FU |
NEO FFI | Neuroticism and Extraversion | BL, Post-T and FU |
EQ-5D | Health-related quality of life | BL, Post-T and FU |
OASIS | Severity of anxiety | Post-module |
ODSIS | Severity of depression | Post-module |
Suicide item | Suicidal ideation | BL, Post-module, Post-T and FU |
Expectation of Treatment Scale | Expectation of treatment | BL |
Opinion of Treatment Scale | Opinion of treatment | Post-T |