AGES-CM: Intervention Module AGES

Sponsor

Celso Arango (Other)

Overall Status

Completed

CT.gov ID

NCT02101372

Collaborator

Comunidad de Madrid (Other)

Enrollment

Location

Arms

17.9

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The AGES-CM consortium aims to study the interaction between the polymorphisms of the candidate genes related with neurodevelopment, neurotransmission, brain progressive changes, cognitive functioning and stressful life events (prospective- and retrospectively assessed) and the association of the interactions with structural and functional brain measures, neuropsychological performance, biochemical and oxidative status in both in patients and controls. The investigators study aimed to examine the effectiveness of a parallel, structured, and specific psychoeducational group intervention (PE) for adolescent patients and their families by comparing it with treatment as usual).

Condition or Disease	Intervention/Treatment	Phase
Psychosis	Behavioral: treatment as usual Behavioral: Psychoeducation group treatment	N/A

Detailed Description

Objective: To assess the effectiveness of a structured psychoeducational group intervention for adolescents with early onset psychosis and their families. The intervention was implemented in parallel in 2 separate groups, by focusing specifically on problem solving strategies and structured psychosis-related information to manage daily life hassles associated with the disease in order to manage crises and prevent relapses.

Method: The investigators performed a 9-month, randomized, rater-blind clinical trial involving adolescent patients with early onset psychosis and 1 or both of their parents. The primary outcomes were number of hospitalizations, days of hospitalization, and visits to the emergency department. The secondary outcome measures were clinical variables and family environment and well being.

Study Design

Study Type:

Interventional

Actual Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Gene and Environment in Schizophrenia- Research Groups in Madrid

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: treatment as usual	Behavioral: treatment as usual case management
Experimental: Psychoeducation Group	Behavioral: Psychoeducation group treatment Psychoeducation therapy problem solving focus

Arm

Intervention/Treatment

Active Comparator: treatment as usual

Behavioral: treatment as usual

case management

Experimental: Psychoeducation Group

Behavioral: Psychoeducation group treatment

Psychoeducation therapy problem solving focus

Outcome Measures

Primary Outcome Measures

number of relapses [Change from baseline to 1 -year follow-up and 2 years follow-up]

Secondary Outcome Measures

clinical severity [1year 2 years]
PANSS, CGAS, GAF, CGI-I

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The presence of at least one positive psychotic symptom (delusions or hallucinations)
Before age 18 diagnosed by DSM-IV
Aged between 14 and 19 years and lived at home with 1 or both parents, caregivers, or legal guardians.

Exclusion Criteria:

The exclusion criteria were patient's drug abuse or dependence at the time of the intervention (drug use was not an exclusion criterion), the presence of any neurological developmental disorder or mental retardation and inability to engage in conversation or read in Spanish that may interfere with the progress of group treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital general Universitario Gregorio Marañón	Madrid		Spain	28007

Sponsors and Collaborators

Celso Arango
Comunidad de Madrid

Investigators

Principal Investigator: Celso Arango, MD, PhD, Hospital General Universitario Gregorio Marañón

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Celso Arango, Head of Department, Hospital General Universitario Gregorio Marañon

ClinicalTrials.gov Identifier:

NCT02101372

Other Study ID Numbers:

P2010/BMD-2422

First Posted:

Apr 2, 2014

Last Update Posted:

Oct 7, 2015

Last Verified:

Oct 1, 2015

Keywords provided by Celso Arango, Head of Department, Hospital General Universitario Gregorio Marañon

first episode psychosis

psychoeducation

group therapy

Additional relevant MeSH terms:

Psychotic Disorders

Mental Disorders

Study Results

No Results Posted as of Oct 7, 2015