Online Transdiagnostic Intervention for Emotional Disorders and Stress-related Disorders

National Autonomous University of Mexico ( UNAM )

Status: Unknown

Conditions: Emotional Disorder; Stress Related Disorder; Depression; Anxiety Disorders

Treatments: Behavioral: Transdiagnostic online intervention; Behavioral: TCC online intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05081830

UNAM_FESI_IT300721

Details and patient eligibility

About

The general objective of this study is to determine the indicators of suitability, clinical utility and satisfaction of the transdiagnostic online intervention for the treatment of emotional disorders and those derived from stress and trauma in a Mexican community sample.

The specific aims are:

• To Carry out a screening evaluation from the transdiagnostic model by evaluating clinical indicators (depression, anxiety, acute / post-traumatic stress, emotional regulation strategies, intolerance to uncertainty) and that allow determining the frequency, intensity and severity of cases identified by type of emotional problem.
• Measure the fidelity of the use of the intervention manual in each treatment condition.
• Evaluate the degree of satisfaction, acceptance, complexity and modality of the transdiagnostic intervention.
• To know the degree of suitability of the transdiagnostic intervention from the point of view of therapists and supervisors in relation to the problems of the studied sample and the recommendations for its improvement.
• To compare the clinical utility of the transdiagnostic intervention via the internet for the treatment of emotional disorders and those derived from stress and trauma against the efficacy of the CBT intervention and the waiting list group.

Full description

In recent decades, research findings indicate that cognitive-behavioral interventions, from a disorder-specific perspective, have shown great empirical support and constitute the first-line treatment for anxiety and depression care. However, these treatments are little used. In this regard, various reasons have been noted that explain the limited access and lack of availability to effective interventions; a minority of people actively seek psychological care due to their own condition of emotional distress, for fear of social stigma, for geographical reasons that separate them from health centers, for reasons of time, preference for another type of treatment or self -help, by the high cost of psychological support, which makes it inaccessible and unaffordable for both the user and the public health system. Likewise, it has been exposed that comorbidity between mental disorders, as well as the gap between research findings and clinical practice, could influence the little dissemination of effective treatments; which leads to a lack of up-to-date professionals who provide relevant interventions. Emotional dysregulation of negative affect has been found to be a study factor that is providing relevant data for a better understanding and approach to emotional disorders from a transdiagnostic perspective, a term coined from a dimensional conception to designate effective treatments aimed at two or more specific disorders. Thus, transdiagnostic treatments could help to overcome the drawbacks related to comorbidity between disorders. Now, technological progress has generated alternatives for psychological assistance, both for the evaluation and for the treatment of different emotional disorders. In this regard, the possibilities offered by technologies are highlighted; since the intervention programs supported by the Internet have been empirically tested to achieve effectiveness and efficiency / cost-benefit, and can be key to guaranteeing access to those who the interventions are inaccessible. Thus, the present study has the purpose of knowing the indicators of suitability, clinical utility and satisfaction of the transdiagnostic intervention via videoconferencing for the treatment of emotional disorders and those derived from stress and trauma.

Hypothesis

• The transdiagnostic intervention program via the internet will reduce symptoms of anxiety / depression and / or comorbid acute stress compared to a cognitive-behavioral treatment (CBT) group and a waiting list group.
• The transdiagnosis intervention program via internet will show statistical gains in the reduction of symptoms of anxiety / depression and / or acute stress, and a clinically significant improvement greater than the CBT intervention program and the waiting list group.
• There will be a higher acceptance / satisfaction index reported by the participants in the transdiagnostic intervention program via the internet compared to the CBT intervention and with the group without treatment.
• It will be found that emotional regulation functions as moderating variables of clinical change.
• The changes will be maintained for three and six months after the end of the transdiagnosis intervention program.

Enrollment: 159 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. be of legal age;
2. voluntarily participate in the study;
3. meet diagnostic criteria for emotional disorders (anxiety or depression) according to the International Neuropsychiatric Interview- Mini, version 5.0, and show a score ≤ 25 on the Beck Anxiety Depression Inventory and / or ≤ 30 on the Inventory Depression of Beck-BDI-II,
4. have access to a computer equipment with an Internet connection, (e) have a valid email address, (f) have basic digital skills in the use of a system operating and internet browsing.

Exclusion criteria

1. psychotic disorder;
2. alcohol and drug abuse;
3. medical illness whose severity or characteristics prevent the performance of the intervention;
4. be receiving psychological and / or pharmacological treatment during the study.

Elimination criteria:

1. not accepting the conditions of informed consent
2. absence in two consecutive sessions to the synchronous treatment sessions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

159 participants in 3 patient groups

transdiagnostic intervention via the Internet

Experimental group

Description:

Treatment provided in eight individual sessions of 60 min., Once a week by videoconference. The integrity of the treatment will be controlled through the therapist's manual (Barlow et al., 2011) adapted for the Mexican population and to the online modality.

Treatment:

Behavioral: Transdiagnostic online intervention

TCC intervention via the Internet

Active Comparator group

Description:

The TCC intervention program is short, with active, focused and directive participation, in 8 individual weekly sessions of one hour by videoconference.

Treatment:

Behavioral: TCC online intervention

waiting list control.

No Intervention group

Description:

Participants in the control group on the waiting list will be assigned to the intervention after 2 months after randomization and will join the Transdiagnostic intervention.