Feasibility and Effectiveness - MAP Online Program - Emerging Adults - Phase II | Registro Público Cubano de Ensayos Clínicos

Feasibility and Effectiveness - MAP Online Program - Emerging Adults - Phase II

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

ECA-MAP-4

Scientific title:

Feasibility and Effectiveness Study of the Mindfulness and Acceptance Based Program (MAP) in online format in emerging adults of the Technical University of Manabi

Acronym of Scientific Title:

ECA-MAP-4

Secondary indentifying numbers:

cif7Fuce-cv-fcp-3

Issuing authority of the secondary identifying numbers:

Research Department of the Central University of Ecuador

Source(s) of monetary or material support:

Central University of Ecuador

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Maria

Midle name:

de Lourdes

Last name:

Rosales Villacres

Medical Specialty :

Psychotherapist

Affiliation:

Faculty of Psychological Sciences, Central University of Ecuador

Postal address:

Bolivia s/n and Eustorgio Salgado

City:

Quito

Country:

Ecuador

Zip Code:

170521

Telephone:

+593-960800668

Email address:

mdrosales@uce.edu.ec

lurosalesv@gmail.com

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Ecuador

Clinical sites:

Province of Manabí, Technical University of Manabi, Mercedes Cedeño, PhD (c), Bachelor's Degree in Social Work, Master's Degree in Methods and Techniques of Research in Social Work

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

01/02/2023

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Intimacy avoidance/abandonment anxiety

Health condition(s) code:

Anxiety, Separation

Anxiety Disorders

Interpersonal Relations

Intervention(s):

Group I (Experimental): Program based on Mindfulness and Acceptance and Commitment Therapy (ACT) in online format. There will be 8 sessions by virtual means and through Moodle platform, with 2 hours of duration each, 2 weekly sessions for a month. Group II (Active Control): It will be based on a psycho-educational orientation on general interpersonal relationships. There will be 8 online sessions: in the first one, socialization of the program and initial evaluation, 6 deliveries of readings through e-mail, twice a week and a last session for final evaluation and closing.

Intervention code:

Acceptance and Commitment Therapy

Mindfulness

Teletherapy

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Avoidance/anxiety (relationship experience questionnaire). Time of measurement: before the start of the program, after one month and after three months.

Key secondary outcomes:

Mindfulness (Five facet Mindfulness Questionnaire). Time of measurement: before the beginning of the program, after one month and after three months. Psychological flexibility (Acceptance and Action Questionnaire II). Time of measurement: before the beginning of the program, after one month and after three months. Psychological well-being (Pemberton Happiness Index). Time of measurement: before the beginning of the program, after one month and after three months.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years old

Maximum age:

25 years old

Inclusion criteria:

1. Be between 18 and 25 years of age. 2. Currently be in some type of relationship. 3. No experience in Mindfulness or meditation. 4. Signed informed consent. 5. Score medium/high on avoidance/anxiety on the Experiences in Close Relationships test. 6. Consider whether he/she will actually be able to participate in at least 5 of the 8 sessions.

Exclusion criteria:

a) People who are attending a psychologist or psychiatrist for a mental health problem. b) Are experiencing a recent grief process c) Physical illness that influences the commitment to attend the course d) Practice meditation

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Prevention

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Parallel

Phase:

2

Target sample size:

90

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

María

Middle Name:

de Lourdes

Last Name:

Rosales Villacres

Specialty:

Psychotherapist

Affiliation:

Faculty of Psychological Sciences, Central University of Ecuador

Postal Address:

Bolivia s/n and Eustorgio Salgado

City:

Quito

Country:

Ecuador

Zip Code:

170521

Telephone:

+593960800668

Email :

mdrosales@uce.edu.ec

lurosalesv@gmail.com

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

María

Middle Name:

de Lourdes

Last Name:

Rosales Villacres

Specialty:

Psychotherapist

Affiliation:

Faculty of Psychological Sciences, Central University of Ecuador

Postal Address:

Bolivia s/n and Eustorgio Salgado

City:

Quito

Country:

Ecuador

Zip Code:

170521

Telephone:

+593960800668

Email :

mdrosales@uce.edu.ec

lurosalesv@gmail.com

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Ethics Committee for Research in Human Beings of the Central University of Ecuador (CEISH-UCE)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

12/04/2022

Postal address of Ethic Committee :

Ciudadela universitaria. Av. América y Av. Universitaria. Edif. Servicios Generales. PB

Telephone:

+5933216365, +5922902192

Email:

ceish.uce@uce.edu.ec, comite.etica@uce.edu.ec

About study completion

Section to complete the data related to the study completion.

Study completion date:

31/07/2023

Date of available results:

30/11/2023

Date of first publication:

31/12/2023

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000415

Date of Registration in Primary Registry:

30/01/2023

Record Verification Date:

2023/02/13

Next update date:

2024/02/13

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