Revisions for Mindfulness and development of well-being in the couple relationship experience of young adults: A protocol of a randomized controlled trial | Registro Público Cubano de Ensayos Clínicos

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--- 13 November 2019 - 5:32pm by Gladys
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Revision of 8 August 2022 - 9:14am:

Mindfulness and development of well-being in the couple relationship experience of young adults: A protocol of a randomized controlled trial

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-4

Scientific title:

Mindfulness and development of well-being in the couple relationship experience of young adults: A protocol of a randomized controlled trial

Acronym of Scientific Title:

ECA-4

Secondary indentifying numbers:

DOCT-DI-2018-36

Issuing authority of the secondary identifying numbers:

Research Direction of 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:

-

Telephone:

+593-96080066

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:

Not applicable

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

26/09/2019

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:

Avoidance to intimacy/anxiety to abandon

Health condition(s) code:

Anxiety, Separation

Couple relationships

Healthy Volunteers

Health condition keyword:

Avoidance to intimacy

Intervention(s):

Group I (Experimental): Program based on Mindfulness and Acceptance and Commitment therapy (ACT), of 8 face-to-face sessions, 2 hours long, 2 weekly sessions for one month. Group II (Active Control): It will be based on a psychoeducational orientation on interpersonal relationships of a general nature. Two face-to-face sessions: one initial and one final, 6 deliveries of information through emails, 2 weekly sessions for one month.

Intervention code:

Mindfulness

Psychotherapy

Acceptance and Commitment Therapy

Couples Therapy

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):

Anxiety / avoidance (experience questionnaire in relationships). Measurement time: before the start of the program, after one month and after three months.

Key secondary outcomes:

Mindfulness (fice facet Mindfulness Questionnaire). Measurement time: before the start of the program, after one month and after three months. Psychological flexibility (Acceptance and Action Questionnaire II). Measurement time: before the start of the program, after one month and after three months. Psychological well-being (Ryff Psychological Well-being Scale). Measurement time: before the start 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

Maximum age:

25 years

Inclusion criteria:

1. Be between 18 and 25 years old. 2. Be currently in some kind of relationship. 3. No experience in Mindfulness or meditation. 4. Signature of informed consent. 5. Score medium / high in avoidance / anxiety of the Experiences in close relationships test. 6. Consider whether you can really participate in at least 5 of the 8 sessions.

Exclusion criteria:

1. People who assist the psychologist or psychiatrist for any mental health problem. 2. Significant recent loss. 3. Physical illness that influences the commitment to attend the course. 4. 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:

N/A

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:

Maria

Middle Name:

De Lourdes

Last Name:

Rosales Villacres

Specialty:

Psychotherapist

Affiliation:

Faculty of Sychological Sciences, Central University of Ecuador

Postal Address:

Bolivia s/n and Eustorgio Salgado

City:

Quito

Country:

Ecuador

Zip Code:

-

Telephone:

+593 960 800 668

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:

Maria

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:

-

Telephone:

+593 960 800 668

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:

Subcommittee on Research Ethics in Human Beings of the Central University of Ecuador

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

27/02/2018

Postal address of Ethic Committee :

Ciudadela Universitaria, Quito. Ecuador

Telephone:

+593 23216365

Email:

comite.etica@uce.edu.ec

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

54

Study completion date:

31/03/2020

Date of available results:

30/04/2020

Date of first publication:

30/12/2020

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:

RPCEC00000303

Date of Registration in Primary Registry:

13/11/2019

Record Verification Date:

2022/08/08

Next update date:

2023/08/08

Link to the spanish version:

Click here

Registered Trials

Registration process

Mindfulness and development of well-being in the couple relationship experience of young adults: A protocol of a randomized controlled trial

About the RPCEC

Useful resources