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Completed

NCT Number: NCT03622151

Homeless Population and Mental Health: Impact of Primer la Llar Program

The main goal is to evaluate the impact of the Primer La Llar housing program for the homeless population on the mental health of the participants.

The hypothesis is that the housing program, which follows Housing first model, for the homeless population has a positive impact on the mental health of the participants, compared to the group that does not receive the intervention -treatment as usual group (meaning the "positive impact" a lower score on the symptomatology scales and lower toxic intake in the group receiving the intervention).

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Key information

Conditions

Mental Health Disorder Behavior Mental Disorders Personal Satisfaction Psychological Well-Being

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The specific objectives are:

Identify the socio-demographic and clinical characteristics of the participants.

Compare the severity of psychiatric symptoms and improvement among the participants in the intervention group and the control group (depressive, anxious, psychotic or manic symptomatology, depending on the case).

Compare the consumption of alcohol and drugs among the participants of both groups.

Compare the basic daily life skills among the participants in both groups, as well as the improvement of them in the experimental group.

Compare the use of services and between the participants of the intervention group and the control group.

Intervention group receives entry to the program (which means individual and permanent housing without previous requirements such as abstinence, compliance with treatment or sobriety.

Control group receives treatment as usual, as they are users of homeless population network of Barcelona.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Single people, adults (exceptionally sentimental couples, friends with positive support relationship for both).
  • Long life on the street (minimum 1 year staying overnight on the street) and / or accommodation centers without linking, using them in a timely manner in the last year.
  • Social needs concurrent to the lack of housing: mental illness and / or drug abuse.
  • Functional autonomy for daily life.
  • Have regular economic income or possibility of obtaining them.
  • Sign informed consent form.

Exclusion criteria

  • language barrier
  • severe neurological or organic pathology
  • severe dementia
  • alcoholic dementia Wernicke Korsakoff

Treatment and study plan

Primer la Llar program

Other

Housing First model: permanent housing without previous requirements such as abstinence, sobriety or compliance with treatment.

Primary outcomes

  1. Prevalence and gravity of psychotic symptoms in both groups

    Time frame: Up to 21 months

    PANSS scale (Positive And Negative Syndrome Scale). Subscales: 1. PANSS-P-Positive (7 ítems): range 7-49 (minimum and maximum scores) 2. PANSS-N-Negative (7 ítems). Range: 7-49. 3. PANSS-PG- general psychopathology (16 ítems). Range: 16-112. Higher values represent a worse outcome. Subscales are summed to compute a total score.

  2. Prevalence and gravity of anxious symptoms in both groups

    Time frame: Up to 21 months

    HARS scale (Hamilton Anxiety Rating Scale). Total range:0-56. Higher values represent a worse outcome.

  3. Prevalence and gravity of depressive symptoms in both groups

    Time frame: Up to 21 months.

    HDRS scale (Hamilton Depression Rating Scale). Total range: 0-52. Higher values represent a worse outcome.

Secondary outcomes

  1. Changes in number of visits to the emergency room/health center/specialist doctors

    Time frame: Up to 21 months

    To see if there are increases or decreases in use of general and specific health services; questionnaire on use of services.

  2. Basic skills of daily life

    Time frame: Up to 21 months

    BELS scale (Basic everyday living skills). Range subscales:

    self-care (0-40) domestic skills (0-28) community skills (0-16) and activity and social relations (0-20). Higher value reports better outcome. Subescales are summed to compute a total score.

  3. Sociodemographic and psychopathological description of both groups

    Time frame: Up to 21 months

    Number of participants from each country, average age, number of men and women, number of participants with a problem of substance abuse or mental health, etc.

    Assessed by a questionnaire about clinical and socio-demographic items.

  4. Number of participants with an alcohol abuse problem assessed by Audit test

    Time frame: Up to 21 months

    Changes in alcohol abuse in both groups Audit test (0-40). Higher value reports worse outcome.

  5. Number of participants with a drug abuse problem assessed by questionnaire on drug abuse

    Time frame: Up to 21 months

    Increase or decrease on drug abuse in both groups

Sponsors and collaborators

Lead sponsor

Parc Sanitari Sant Joan de Déu

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Aug 9, 2018
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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