Efectiveness- hypnotherapy- depressed patients

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:

EHDP

Scientific title:

Efectiveness of hypnotherapy in depressed patients.

Acronym of Scientific Title:

EHDP

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Santiago de Cuba University of Medical Sciences (UCMSC)

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:

Alberto

Last name:

Cobian Mena

Medical Specialty :

Health Psychology

Affiliation:

Santiago de Cuba University of Medical Sciences. Hypnosis Clinic

Postal address:

Las Americas Avenue, without number, between E st. and I st., Sueno

City:

Santiago de Cuba

Country:

Cuba

Zip Code:

90400

Telephone:

+53-22644710

Email address:

alberto.cobian@infomed.sld.cu [1]

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:

Cuba

Clinical sites:

Not applicable

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

22/11/2012

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:

Depression

Health condition(s) code:

Depression

Behavioral Symptoms

Behavior

Behavior and Behavior Mechanisms

Intervention(s):

Study group: Hypnotherapy, with a maximum of 10 sessions that lasted from 45 minutes to 1 hour with a weekly frequency. Control group: Rational-emotional-behavioral therapy for 10 weeks with a weekly frequency.

Intervention code:

Hipnose

Psychotherapy

Cognitive Behavioral Therapy

Psychotherapy, Rational-Emotive

Intervention keyword:

hypnotherapy

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):

1- Not Anti-depressive psychological response (Psychological response obtained by Zung and Count test: 1. Improved, 2. Not improved). Measurement time: 1 hour after sessions 1 and 10. 2- Anxiolytic psychological effect (Psychological response obtained by Beck's anxiety test: 1. Improved, 2.Not improved). Measurement time: 1 hour after sessions 1 and 10.

Key secondary outcomes:

Not applicable

Selection criterias

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

Gender:

Male/Female

Minimum age:

16 years

Maximum age:

None

Inclusion criteria:

1. Diagnosis of Exogenous Depression and Neurotic Functioning Level. 2. Patients over 15 years of age of both sexes. 3. Patients who express their informed consent to participate in the research.

Exclusion criteria:

1. Patients diagnosed with endogenous depression. 2. Patients with major psychiatric disorders or mental deficit.

Type of population:

Children and Adults

Type of participant:

Patients

Study design

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

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

N/A

Target sample size:

150

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:

Marcos

Last Name:

Zaldivar Hernandez

Specialty:

Health Psychology

Affiliation:

Polyclinic "30 de Noviembre"

Postal Address:

10 st. without number, corner to General Miniet, Santa Barbara

City:

Santiago de Cuba

Country:

Cuba

Zip Code:

90400

Telephone:

+53-22646964

Email :

mezaldivar@infomed.sld.cu [2]

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:

Sara

Last Name:

Salas Palacios

Specialty:

Second degree Specialist in Pediatric

Affiliation:

Santiago de Cuba University of Medical Sciences (UCMSC)

Postal Address:

Las Americas Avenue, without number, between E st. and I st. Sueno

City:

Santiago de Cuba

Country:

Cuba

Zip Code:

90400

Telephone:

+53-22641608

Email :

sara.salas@infomed.sld.cu [3]

Research Ethics Committees

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

Name of Research Ethics Committees:

Research Ethics Committee of the Santiago de Cuba University of Medical Sciences

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

25/10/2012

Postal address of Ethic Committee :

Avenida de Las Americas s/n entre Calle E y Calle I, Reparto Sueno, Santiago de Cuba

Telephone:

+53-58149967

Email:

rhodelintablada@gmail.com

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

150

Study completion date:

19/12/2018

Date of available results:

02/10/2020

Date of first publication:

14/04/2021

Results Study

Section to complete the data related to the summarized results.

Url for Results File:

http://revmedicaelectronica.sld.cu/index.php/rme/article/view/4383/html_884

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:

RPCEC00000364

Date of Registration in Primary Registry:

06/04/2021

Record Verification Date:

2021/06/17

Next update date:

2022/06/17

Link to the spanish version:

Click here [4]