Psychological DistressEnsembleNCT04020497
Ensemble Programme an Early Intervention for Informal Caregivers of Psychiatric Patients
A study testing Ensemble programme and SAU in people with Psychological Distress, run by Institut et Haute Ecole de la Santé la Source at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress
- What is being tested?
- Ensemble programme and SAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2019to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being at least 18 years old
- Living in the French-speaking cantons of Switzerland (commonly referred to as "Romandy")
- Speaking French
- Having an adult relative suffering from a psychiatric disorder (with or without an established diagnosis)
- Having the capacity to agree to participate in the project
Who cannot join
- Having les than 20 on the Zarit score.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
La Source, School of Nursing Sciences, HES-SO University of Applied Sciences Western Switzerland, Lausanne.
Lausanne, Canton of Vaud, 1004
About this study
Official title: Ensemble Programme an Early Intervention for Informal Caregivers of Psychiatric Patients: a Randomized Controlled Trial
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.
Read the detailed description
The recent statistics showed that mental disorders affect one in four people in the world. In this context, informal caregivers are key actors in the health care system through their support. This support can be associated with very high burden and distress. Informal caregivers can experience serious situations with potential negative consequences on their quality of life, their own health and the health of patients. Data recommended to intervene at the onset of disease to improve the impact of an intervention. It seems important also to intervene while the patient is in an acute phase of illness to better support informal caregivers' emotional needs. In addition, providing emotional support for informal caregivers at the beginning of an illness in particular is recommended because this is a critical phase. The experience of painful emotions, such as denial of disease and feelings of being overwhelmed or shocked can have serious consequences on their health and on the patient's recovery. Previous studies identified that informal caregivers need tailored knowledge about the patient's illness, clarification about their roles and responsibilities, better control over their own life and effective collaboration with health professionals. Most of the interventions published in the literature focus on the ill family member and its support but not on the specific needs of the informal caregivers as the core intervention. To reduce the gap between scientific recommendations and actual practice, the investigators developed, tailored and tested a new intervention called Ensemble.
Ensemble is a brief individualized intervention designed to promote the well-being of informal caregivers who experience the effects of patients' psychiatric disorders. The five-session Ensemble program provided to informal caregivers targeted support to address their specific unmet needs, emotions and social resources. A professional addressed this programme to the informal caregiver delivered independently of the patient's treatment.
Ensemble assesses the needs of informal caregivers and provides a tailored brief support. Results of a pilot study showed that psychological health and optimism of informal caregivers were improved. For these reasons, there is a clear research and clinical need to establish whether Ensemble programme is clinically effective by using a randomized, controlled, and assessor-blind trial. A combination of Ensemble plus support as usual (SAU) will be compared to SAU alone. Informal caregivers of individuals suffering from mental disorders will undergo either intervention for five sessions, during a six weeks average time. Measure will assess participants' current psychological health state and optimism. These different measures will be performed at the time of inclusion, at the end of the intervention, and at two months follow-up. At the end of the program, individual qualitative structured interviews will be performed to assess acceptability of the programme.
- Conditions
- Psychological Distress
- Being tested
- Ensemble programme, SAU
- Keywords
- target support, informal caregiver, recovery, well-being, burden, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensemble programmeBehavioural
Also called Ensemble
Ensemble is a individualized programme to address informal caregiver's specific unmet needs, emotions and social resources, in order to offer a targeted support in five sessions.
SAUOther
Also called Support as usual
Informal caregivers have often to manage the situation in usual different ways. Support as usual (SAU) alone consists of an informal support by patient's clinical team. Specific psychoeducational programs depending on patient's illnes (like "Profamille" for schizophrenia) or peer-support depending to the voluntary work of families' associations. Some general professional services focused on informal caregivers or relatives in order to inform and orient them if they are avaible in the study area. No attempts have been made to standardize this treatement as SAU depend to informal caregiver's need and knowledge of the health system, also her/his capacity or possibility to be in contact with patient's clinical team.
| Study group | Role | What they receive |
|---|---|---|
| Ensemble + SAU (Support as usual) | Experimental | The five-session Ensemble program provided to informal caregivers targeted support + SAU Receives: Behavioral: Ensemble programme; Other: SAU |
| SAU (Support as usual) | Active comparator | SAU alone which was chosen as a control condition. Receives: Other: SAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Distress by Global Severity Index
The Brief Symptom Inventory (BSI) invlude normative data to detect clinical symptoms as indicators of emotional distress, with 53 items on a 5-point Likert-type scale (0-4), ranging from "not at all"=0 to "extremely=4." The items measure physical and psychological symptoms occurring in the preceding 7-day period. It includes three global indices: Global Severity Index (GSI, indicating the global distress level), Positive Symptom Total (PST, indicating the number of symptoms an individual reports) and Positive Symptom Distress Index (PSDI, indicating the average distress level).The Global Severity Index (GSI) is a composite score to measure global distress Min = 0; Max=212: Range 0-3.83, a higher score reprensent a severer global distress level. The interpretation
Measured: Baseline, T1 at 2 months, and T2 at 4 months
Secondary outcomes (4)
Optimism Level
Assessement of optimism level (LOT-R scale). The Life Orientation Test - Revised (LOT-R) measures an individual's optimism regarding a given situation. This scale includes 10 items; three items measure optimism, three other measure pessimism, and four of the 10 items function as fillers. Items are answered by a Likert-type of scale which varies from 0 (strongly disagree) to 4 (strongly agree). LOT-R score can range from 0 to 24, Min=0, Max=40; 0-13 Low Optimism (High Pessimism); 14-18 Moderate Optimism; 19-24 High Optimism (Low Pessimism). Higher values represent better outcome.
Measured: Baseline, T1 at 2 months, and T2 at 4 months
Quality of Live - Mental Dimension
36-item Medical Outcome Study Short-Form Health Survey (SF-36) measures health indicators related to the quality of life by 36 items, used in clinical and general population settings to evaluated eight health dimensions: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher score defines a more favorable health state. Each item is scored on a 0 to 100 range, 0 being the lowest and 100 being the highest possible scores.Two global scores, i) A Physical Component Score (PCS) and ii) the Mental Component Score (MCS) obtained by grouping dimensions to have global variables (min=0; max =400). MCS is the addition of the mean scores on the emotional well-being, social functioning,vitality and emotional limitation subscales. Lower MCS scores potentially indicate presence of psychological risk.
Measured: Baseline, T1 at 2 months, and T2 at 4 months
Burden Level
Assessment of the informal caregiver's burden level by the Zarit Burden Interview. This 22-item scale assesses the subjective burden (emotional, physical and financial) for an informal caregiver of an individual with loss of autonomy. The score is obtained by the addition of the 22 items. Scores range between 0 and 88, 61-88 is considered as a high burden, 41-60 is a moderate to high burden, 21-40 is a light to moderate burden and 0-20 is considered as no subjective burden.
Measured: Baseline, T1 at 2 months, and T2 at 4 months
Patient's Social an Occupational Functioning
Social and Occupational Functioning Assessment Scale (SOFAS) is a scale from 0 to 100 demonstrating the patient's social functioning. In this study, this score will be measured according to the informal caregiver's representation. It is used in psychiatry to evaluate how well a patient is functioning in daily life, work, and social relationships.High scores (≥70) indicate good to excellent functioning; Moderate scores (50-69) suggest some difficulties but still some level of independence; Low scores (<50) indicate serious impairments in daily life, often requiring intervention
Measured: Baseline and T2 at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Sep 2019
- Primary completion1 Jan 2021
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut et Haute Ecole de la Santé la Source
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shyhrete Rexhaj, Institut et Haute Ecole de la Santé la Source
- Investigators
- Shyhrete Rexhaj, Principal investigator, Institut et Haute école de la Santé, La Source
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020497
- Sponsor's protocol ID
- EnsembleRCT
- Acronym
- Ensemble
- Status last verified
- May 2025
- First submitted
- 12 Jul 2019
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rexhaj S, Monteiro S, Golay P, Coloni-Terrapon C, Wenger D, Favrod J. Ensemble programme for early intervention in informal caregivers of psychiatric adult patients: a protocol for a randomised controlled trial. BMJ Open. 2020 Jul 30;10(7):e038781. doi: 10.1136/bmjopen-2020-038781.
PubMed 32737097Rexhaj S, Nguyen A, Favrod J, Coloni-Terrapon C, Buisson L, Drainville AL, Martinez D. Women involvement in the informal caregiving field: A perspective review. Front Psychiatry. 2023 Jan 18;14:1113587. doi: 10.3389/fpsyt.2023.1113587. eCollection 2023.
PubMed 36741114Rexhaj S, Martinez D, Golay P, Coloni-Terrapon C, Monteiro S, Buisson L, Drainville AL, Bonsack C, Ismailaj A, Nguyen A, Favrod J. A randomized controlled trial of a targeted support program for informal caregivers in adult psychiatry. Front Psychiatry. 2023 Nov 30;14:1284096. doi: 10.3389/fpsyt.2023.1284096. eCollection 2023.
PubMed 38098635
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ensemble Programme an Early Intervention for Informal Caregivers of Psychiatric Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04020497
- Acronym / sponsor ID
- Ensemble / EnsembleRCT
- Conditions
- Psychological Distress
- Keywords
- target support, informal caregiver, recovery, well-being, burden, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Institut et Haute Ecole de la Santé la SourceUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Posted 25 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The recent statistics showed that mental disorders affect one in four people in the world. In this context, informal caregivers are key actors in the health care system through their support. This support can be associated with very high burden and distress. Informal caregivers can experience serious situations with potential negative consequences on their quality of life, their own health and the health of patients. Data recommended to intervene at the onset of disease to improve the impact of an intervention. It seems important also to intervene while the patient is in an acute phase of illness to better support informal caregivers' emotional needs. In addition, providing emotional support for informal caregivers at the beginning of an illness in particular is recommended because this is a critical phase. The experience of painful emotions, such as denial of disease and feelings of being overwhelmed or shocked can have serious consequences on their health and on the patient's recovery. Previous studies identified that informal caregivers need tailored knowledge about the patient's illness, clarification about their roles and responsibilities, better control over their own life and effective collaboration with health professionals. Most of the interventions published in the literature focus on the ill family member and its support but not on the specific needs of the informal caregivers as the core intervention. To reduce the gap between scientific recommendations and actual practice, the investigators developed, tailored and tested a new intervention called Ensemble.
Ensemble is a brief individualized intervention designed to promote the well-being of informal caregivers who experience the effects of patients' psychiatric disorders. The five-session Ensemble program provided to informal caregivers targeted support to address their specific unmet needs, emotions and social resources. A professional addressed this programme to the informal caregiver delivered independently of the patient's treatment.
Ensemble assesses the needs of informal caregivers and provides a tailored brief support. Results of a pilot study showed that psychological health and optimism of informal caregivers were improved. For these reasons, there is a clear research and clinical need to establish whether Ensemble programme is clinically effective by using a randomized, controlled, and assessor-blind trial. A combination of Ensemble plus support as usual (SAU) will be compared to SAU alone. Informal caregivers of individuals suffering from mental disorders will undergo either intervention for five sessions, during a six weeks average time. Measure will assess participants' current psychological health state and optimism. These different measures will be performed at the time of inclusion, at the end of the intervention, and at two months follow-up. At the end of the program, individual qualitative structured interviews will be performed to assess acceptability of the programme.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ensemble + SAU (Support as usual) | Experimental | Behavioral: Ensemble programme, Other: SAUThe five-session Ensemble program provided to informal caregivers targeted support + SAU |
| SAU (Support as usual) | Active comparator | Other: SAUSAU alone which was chosen as a control condition. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being at least 18 years old
- Living in the French-speaking cantons of Switzerland (commonly referred to as "Romandy")
- Speaking French
- Having an adult relative suffering from a psychiatric disorder (with or without an established diagnosis)
- Having the capacity to agree to participate in the project
Key exclusion criteria (1 listed)
- Having les than 20 on the Zarit score.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ensemble programmeAlso: EnsembleEnsemble is a individualized programme to address informal caregiver's specific unmet needs, emotions and social resources, in order to offer a targeted support in five sessions. | Behavioural | Ensemble + SAU (Support as usual) |
| SAUAlso: Support as usualInformal caregivers have often to manage the situation in usual different ways. Support as usual (SAU) alone consists of an informal support by patient's clinical team. Specific psychoeducational programs depending on patient's illnes (like "Profamille" for schizophrenia) or peer-support depending to the voluntary work of families' associations. Some general professional services focused on informal caregivers or relatives in order to inform and orient them if they are avaible in the study area. No attempts have been made to standardize this treatement as SAU depend to informal caregiver's need and knowledge of the health system, also her/his capacity or possibility to be in contact with patient's clinical team. | Other | Ensemble + SAU (Support as usual), SAU (Support as usual) |
Primary outcome
General Distress by Global Severity Index
Time frame: Baseline, T1 at 2 months, and T2 at 4 months
The Brief Symptom Inventory (BSI) invlude normative data to detect clinical symptoms as indicators of emotional distress, with 53 items on a 5-point Likert-type scale (0-4), ranging from "not at all"=0 to "extremely=4." The items measure physical and psychological symptoms occurring in the preceding 7-day period. It includes three global indices: Global Severity Index (GSI, indicating the global distress level), Positive Symptom Total (PST, indicating the number of symptoms an individual reports) and Positive Symptom Distress Index (PSDI, indicating the average distress level).The Global Severity Index (GSI) is a composite score to measure global distress Min = 0; Max=212: Range 0-3.83, a higher score reprensent a severer global distress level. The interpretation
4 secondary outcomes
Optimism Level
Time frame: Baseline, T1 at 2 months, and T2 at 4 months
Quality of Live - Mental Dimension
Time frame: Baseline, T1 at 2 months, and T2 at 4 months
Burden Level
Time frame: Baseline, T1 at 2 months, and T2 at 4 months
Patient's Social an Occupational Functioning
Time frame: Baseline and T2 at 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32737097Rexhaj S, Monteiro S, Golay P, Coloni-Terrapon C, Wenger D, Favrod J. Ensemble programme for early intervention in informal caregivers of psychiatric adult patients: a protocol for a randomised controlled trial. BMJ Open. 2020 Jul 30;10(7):e038781. doi: 10.1136/bmjopen-2020-038781.
- Background: PubMed 36741114Rexhaj S, Nguyen A, Favrod J, Coloni-Terrapon C, Buisson L, Drainville AL, Martinez D. Women involvement in the informal caregiving field: A perspective review. Front Psychiatry. 2023 Jan 18;14:1113587. doi: 10.3389/fpsyt.2023.1113587. eCollection 2023.
- Results publication: PubMed 38098635Rexhaj S, Martinez D, Golay P, Coloni-Terrapon C, Monteiro S, Buisson L, Drainville AL, Bonsack C, Ismailaj A, Nguyen A, Favrod J. A randomized controlled trial of a targeted support program for informal caregivers in adult psychiatry. Front Psychiatry. 2023 Nov 30;14:1284096. doi: 10.3389/fpsyt.2023.1284096. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shyhrete Rexhaj principal investigator
Institut et Haute école de la Santé, La Source
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensemble programme and SAU in people with Psychological Distress, run by Institut et Haute Ecole de la Santé la Source at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Distress by Global Severity Index (time frame: Baseline, T1 at 2 months, and T2 at 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04020497, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.