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Ups & downs in mental health-effectiveness of flexible assertive community treatment in general mental health services - the UDiM-FACT trial

Ups and downs in mental health-effectiveness of flexible assertive community treatment on health and everyday functioning among persons with alarming and complex mental health needs as compared to care as usual

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11268588
Enrollment
330
Registered
2025-10-08
Start date
2020-05-07
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Outpatients in general mental health services with mental health disorders (one or multiple diagnosis of mood-, personality-, substance abuse-, post traumatic stress-, attention deficit disorders). Mental and Behavioural Disorders

Interventions

This is a randomised, assessor-blinded, multicenter trial that will be performed. Participants will be randomly assigned to FACT and care as usual (CAU). Randomisation and blinding: Randomisation wil

Sponsors

Lund University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 67 Years

Inclusion criteria

Inclusion criteria: 1. Residing in Helsingborg, Lund or Malmö municipality catchment areas 2. Being assigned to and being a patient in the general Mental Health Services 3. Age between 18-67 4. Being diagnosed with a mental disorder (one or multiple diagnoses of mood-, personality-, substance abuse-, post-traumatic stress-, attention deficit disorders) 5. Expressing having low everyday functioning associated with a mental disorder 6. Expressing a need for integrated mental health and community Mental Health Services 7. Attending an information meeting (or individually) about the trial study

Exclusion criteria

Exclusion criteria: 1. Being diagnosed with a psychotic mental health disorder 2. Being assigned to mental health services for persons with psychosis

Design outcomes

Primary

MeasureTime frame
1. Health and functioning measured using the WHO Disability Assessment Scale, WHODAS 2.0 (36-items), linked to the International Classification of Functioning, Disability and Health (ICF) theoretical framework, at baseline, 6 and 12 months

Secondary

MeasureTime frame
Secondary outcome measures: Personal recovery: 1. Well-being, measured using the WHO-5 well-being index, at baseline, 6 and 12 months 2. Quality of Life, measured using the Manchester Short Assessment of Quality of Life Scale, at baseline, 6 and 12 months 3. Quality of life, measured using European Quality of Life-5 Dimensions (EQ-5D9) at baseline, 6 and 12 months (also for calculations of quality-adjusted life-years (QALYs) among persons with MHP) 4. Perception of support in relation to connectedness, hope, identity, meaningfulness, and empowerment, measured using the Brief Inspire, at baseline, 6 and 12 months 5. Status of employment, housing, friends, family/partnership roles, measured using Objective Social Outcome Index (SIX), at baseline, 6 and 12 months 6. Personal recovery process, measured using the Questionnaire about the Process of Recovery (QPR) at baseline, 6 and 12 months 7. Self-stigma, measured using the Brief Internalized Stigma of Mental Illness (ISMI) scale, at baseline, 6 and 12 months Clinical recovery: 8. Emotional regulation measured using the Difficult in Emotional Regulation Scale (DERS), at baseline, 6 and 12 months 9. Depression measured using the Montgomery-Asberg Depression Scale-Self rating, at baseline, 6 and 12 months 10. Anxiety measured using the General Anxiety Disorder (GAD), at baseline, 6 and 12 months 11. Self-harm using the Deliberate Self-Harm Inventory (DSHI), at baseline, 6 and 12 months 12. Alcohol- and drug consumption measured using the Alcohol- and Drug Use Identification Tests, at baseline, 6 and 12 months. 13. Care use will be measured using inpatient and outpatient care use indicators and will be retrospectively collected from medical journals and a complementary questionnaire at single points in time. Implementation: 14. FACT fidelity assessment measured using a Swedish version. No study participants will partake.

Countries

Sweden

Contacts

Public ContactUlrika Bejerholm
ulrika.bejerholm@med.lu.se+46-2221958

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026