Clinical Effectiveness of the MultiCentre Pain Monitor to Guide and Personalize Psychological Treatments: A Single Case Design

NCT05098288 | Unknown

• 1 other identifier: ROMEMIUJI
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present project aims at testing the clinical effectiveness of an app-based system called Multicentre Pain Monitor for routine outcome monitoring of adult patients with emotional disorders while they are administered a self-applied transdiagnostic psychological intervention (Unified Protocol).

Conditions

Emotional Disorder

Keywords

Multicentre Pain Monitor; Transdiagnostic approach; Emotional Disorder; Unified Protocol; Clinical effectiveness

Outcome Measures

Primary Outcomes (2)

• Change in Anxiety

  In a scale from 0 (not at all) to 3 (completely), "how was your level of anxiety today?"

  Change from baseline to posttreatment. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline to posttreatment)

• Change in Depression

  In a scale from 0 (not at all) to 3 (completely), "how was your level of depression today?"

  Change from baseline to posttreatment. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline to posttreatment)

Secondary Outcomes (7)

• Change in Activity level

  Change from baseline to posttreatment. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline to posttreatment)

• Change in Emotion Conceptualization

  Change from baseline to posttreatment. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline to posttreatment)

• Change in Emotional Avoidance

  Change from baseline to posttreatment. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline to posttreatment)

• Change in present-focused emotional awareness (Mindfulness)

  Change from baseline to posttreatment. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline to posttreatment)

• Change in Cognitive Flexibility

  Change from baseline to posttreatment. The outcome will be evaluated daily (at 9pm) during 31 days. Changes will be investigated from baseline to posttreatment using all corresponding time points (baseline to posttreatment)

Study Arms (1)

App + Unified Protocol Arm

EXPERIMENTAL

Participants at this condition will be daily monitored by the app (Multicentre Pain Monitor) while they are administered a self-applied online transdiagnostic intervention (Unified protocol) for their emotional disorders. Alarms will be generated in the face of certain pre-set undesired events. Therapists will receive pre-set clinical alarms in real time in the presence of relevant clinical events previously determined by the clinical staff (e.g., clinical worsening or no improvement of functionality, mood or psychological mechanisms worked in therapy). This information will be used to make clinical decisions in a short period of time (e.g., call the patient, or send additional therapeutic material by mail or through the app (momentary ecological intervention), or for its implementation during the course of psychological therapy in order to make the therapy more efficient, safe, personalized and adapted to the needs of the patient

Behavioral: Multicentre Pain Monitor + Unified Protocol

Interventions

Multicentre Pain Monitor + Unified Protocol BEHAVIORAL

The intervention will consist in a self-applied online transdiagnostic intervention for emotional problems together with an app-based EMA. In terms of monitoring, the Multicentre Pain Monitor is a mobile app whose contents have been adapted to conduct ecological momentary assessments in different health conditions. The app assesses important psychological variables, namely anxiety, depressive symptoms,etc. Participants respond daily to the questions in the app. In terms of the online self-applied intervention, the Unified Protocol is a transdiagnostic extension of CBT which works on regulate emotions in a more adaptive way through 5 core treatment modules: present-focused emotional awareness, cognitive flexibility, identification and prevention of emotional avoidance patterns, increasing awareness and tolerance to emotion-elicited physical sensations, and graded (interoceptive and situational) exposure procedures.

Also known as: Multicentre Pain Monitor

App + Unified Protocol Arm

Eligibility Criteria

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

You may qualify if:

• Anxiety or depression problems are the main problematic symptoms
• The patient is over 18 years of age
• The patient is fluent in the language in which the therapy is performed (Spanish in the present study)
• The patient is able to attend to the evaluation and treatment sessions
• The patient signs the informed consent form

You may not qualify if:

• The patient presents a severe mental disorder (bipolar disorder, schizophrenia, or an organic mental disorder) or there is suicide risk at the time of assessment
• The patient has used substances in the last three months (excluding cannabis, coffee, and / or nicotine)
• The patient has previously received 8 or more sessions of psychological treatment with clear and identifiable CBT principles in the past 12 months or is currently receiving psychological treatment

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Officials

• Patricia Gual- Montolio

  Universitat Jaume I

  STUDY CHAIR

• Juana Maria Bretón-López, Ph.D.

  Universitat Jaume I

  STUDY CHAIR

Central Study Contacts

Carlos Suso-Ribera, Ph.D.

CONTACT

964 387643; susor@uji.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Case Design (n=1) (multiple baselines)

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 28, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share