NCT04020497 (Ensemble) is a NA clinical trial of Ensemble programme in Psychological Distress, sponsored by Institut et Haute Ecole de la Santé la Source.

Who is sponsoring NCT04020497?

NCT04020497 is sponsored by Institut et Haute Ecole de la Santé la Source.

What drugs are being tested in NCT04020497?

Interventions in NCT04020497: Ensemble programme, SAU.

What condition does NCT04020497 study?

NCT04020497 studies Psychological Distress.

Is NCT04020497 still recruiting?

NCT04020497 is currently status unknown. Last updated 20 August 2021.

Last reviewed 2021-08-20 · How we verify

NCT04020497: Ensemble

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Ensemble Programme an Early Intervention for Informal Caregivers of Psychiatric Patients

Status unknown NA Last updated 20 August 2021

What this trial tests

NA trial testing Ensemble programme in Psychological Distress in 70 participants. Status unknown.

Timeline

1 September 2019

Primary endpoint
1 January 2021

30 April 2023

Quick facts

Lead sponsor	Institut et Haute Ecole de la Santé la Source
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	70
Start date	1 September 2019
Primary completion	1 January 2021
Estimated completion	30 April 2023
Sites	1 location across Switzerland

Drugs / interventions tested

Ensemble programme
SAU

Conditions studied

Psychological Distress — all drugs for Psychological Distress →

Sponsor

Institut et Haute Ecole de la Santé la Source

Who can join

Adults 18 to 90, any sex, with Psychological Distress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study focuses on the difficulties of maintaining optimal psychological health and quality of life for caregivers in adult psychiatry while they play an important role in helping patients with severe psychiatric disorders. It evaluates the addition of a 5 session psychological program, named Ensemble. Half of the participants will receive their usual support and Ensemble in combination, while the other half will receive usual support only.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Ensemble programme for early intervention in informal caregivers of psychiatric adult patients: a protocol for a randomised controlled trial.
Rexhaj S, Monteiro S, Golay P, Coloni-Terrapon C, et al · · 2020 · cited 4× · PMID 32737097 · DOI 10.1136/bmjopen-2020-038781
A randomized controlled trial of a targeted support program for informal caregivers in adult psychiatry.
Rexhaj S, Martinez D, Golay P, Coloni-Terrapon C, et al · · 2023 · cited 1× · PMID 38098635 · DOI 10.3389/fpsyt.2023.1284096

Verify or expand the search:

Other recruiting trials for Psychological Distress

Currently open trials in the same condition.

NCT07481890 — Feasibility and Efficacy of the EMDR Toolbox Method in Cancer Patients. · NA · recruiting
NCT07392437 — Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and I · NA · recruiting
NCT07335302 — CARE-BI:a Pilot Study to Improve Patient Comfort and Reduce Psychological Distress During IA Removal · recruiting
NCT07447089 — EMDR Integrative Group Protocol and Individual Treatment for Patients With Cancer: A Pilot Study · NA · recruiting
NCT07214428 — Effects of Grape Powder on Psychological Distress and Gut Microbiota in College Students · NA · active not recruiting

Other Institut et Haute Ecole de la Santé la Source trials

Trials by the same sponsor.

NCT07068009 — Training and Support Programme on Data-driven Quality Development for Swiss Long-Term Care Facilities (NIP-Q-UPGRADE Sub · NA · active not recruiting
NCT06035770 — The Effectiveness of Mental Health First Aid Intervention Among Undergraduate Students in Switzerland · NA · completed
NCT03283891 — Effects on Nurses' Quality of Working Life of an Educational Intervention to Strengthen Their Humanistic Practice · NA · completed
NCT02593058 — Positive Emotions Program for Schizophrenia (PEPS) · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04020497 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Institut et Haute Ecole de la Santé la Source
Last refreshed: 20 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04020497.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing