Integrated Care (IC) with or without Assertive Community Treatment (ACT): a 12- month open randomized single blind trial in patients with early psychosis with 6-month post intervention follow-up (ACCESS study)

Integrated Care (IC) with or without Assertive Community Treatment (ACT): a 12- month open randomized single blind trial in patients with early psychosis with 6-month post intervention follow-up (ACCESS study) - ACCESS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000126

Enrollment

122

Registered

2009-10-12

Start date

2011-01-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Schizophrenia (DSM-IV-TR 295.xx) Schizophreniform disorder (DSM-IV-TR 295.40) Schizoaffective disorder (DSM-IV-TR 295.70) Delusional disorder (DSM-IV-TR 297.1) Psychotic disorder not otherwise specified (DSM-IV-TR 298.9) Bipolar I disorder (DSM-IV-TR 296.44

Interventions

Group 1: Integrated Care with Assertive Community Treatment for a period of 12 months Group 2: Integrated Care without Assertive Community Treatment for a period of 12 months

Eligibility

Sex/Gender

All

Age

18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Male or female, age 18 to 35, with sufficient command of German language. Meet definition for early psychosis: a. Either first or second admission (within 2 years of first admission) to in-patient or day patient unit for treatment of psychosis; b. DSM-IV TR criteria for Schizophrenia (295.xx), Schizophreniform disorder (295.40), Schizoaffective disorder (295.70), Delusional disorder (297.1), Psychotic disorder not otherwise specified (298.9), Bipolar I disorder (including 296.44, 296.54 and 296.64), and Major depression, single or recurrent episode, severe with psychotic symptoms (296.24 and 296.34); c. Positive psychotic symptoms for 4 weeks or more; d. Score of 4 or more (moderate to severe) on the PANSS (Kay et al. 1989) target item either for delusions (P1) or hallucinations (P3). Outpatients or inpatients; Able and willing to meet or perform study requirements and consent

Exclusion criteria

Exclusion criteria: Diagnosis of following psychotic disorders according to DSM-IV TR: a. Alcohol or substance-induced psychosis (i.e. 291.3, 291.5, 292.xx: -.11 or -.12), b. Psychotic disorder due to a general medical condition (i.e. 293.0, 290.12, 290.20, 290.42, 293.89), c. Brief Psychotic Episode (298.8). Mental retardation (intellectual quotient < 70). Pregnancy.

Design outcomes

Primary

Measure	Time frame
Time to Service Disengagement: The primary outcome of the study will be the time to service disengagement within the 12-month intervention period. According to Schimmelmann et al. (2006) service disengagement (SD) is defined as present, if a study participant actively refused any contact with the treatment facility or is not traceable (after at least >= 5 attempts). Routinely, the ACT team will made extensive efforts to reengage patients by repeated telephone calls, letters to the participants and their families, and home visits throughout the entire intervention period. The date of last face-to-face contact between case managers in both treatment arms (ACT or IC) and a particular disengaged participant will be regarded as the date of disengagement. The primary statistical analysis will consist of a stratified log-rank test with time to service disengagement as the primary outcome variable with a type-I error of 0.05 two-sided, the strata being the two centers that participate. The sample size calculation was based on the assumption of a disengagement rate of 25% in the control group vs. 10% in the intervention group according to previous studies. For a fixed sample size design, this would require 2x61 patients to reach a power of 80% if one assumed a recruitment period of two years and a follow-up time of 18 months.	—

Measure

Time frame

Time to Service Disengagement: The primary outcome of the study will be the time to service disengagement within the 12-month intervention period. According to Schimmelmann et al. (2006) service disengagement (SD) is defined as present, if a study participant actively refused any contact with the treatment facility or is not traceable (after at least >= 5 attempts). Routinely, the ACT team will made extensive efforts to reengage patients by repeated telephone calls, letters to the participants and their families, and home visits throughout the entire intervention period. The date of last face-to-face contact between case managers in both treatment arms (ACT or IC) and a particular disengaged participant will be regarded as the date of disengagement. The primary statistical analysis will consist of a stratified log-rank test with time to service disengagement as the primary outcome variable with a type-I error of 0.05 two-sided, the strata being the two centers that participate. The sample size calculation was based on the assumption of a disengagement rate of 25% in the control group vs. 10% in the intervention group according to previous studies. For a fixed sample size design, this would require 2x61 patients to reach a power of 80% if one assumed a recruitment period of two years and a follow-up time of 18 months.

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Secondary

Measure	Time frame
Improvements of symptoms, functioning, quality of life, medication adherence, patients' and relatives' satisfaction with care, cost-effectiveness, and stability of possible ACT-related improvements over 6-month without ACT For the comparison of dimensional secondary outcome measures across the observation period, i.e. symptoms, functioning, quality of life, medication adherence, service engagement, and satisfaction with care, a series of Mixed Models Repeated Measures (MMRM) analyses will be specified (Mallinckrodt et al. 2001, 2004). This likelihood-based repeated measures approach, which is similar to a repeated measure ANOVA, has proven to be superior to e.g. last observation carried forward ANOVA in simulation scenarios patterned after acute phase neuropsychiatric clinical trials (Mallinckrodt et al. 2001, 2004) and is actively employed in schizophrenia research (Kennedy et al. 2003). Health economics will be analyzed according to the method of Knapp et al. (2008) using Quality-Adjusted Life Years (QALYs).	—

Measure

Time frame

Improvements of symptoms, functioning, quality of life, medication adherence, patients' and relatives' satisfaction with care, cost-effectiveness, and stability of possible ACT-related improvements over 6-month without ACT For the comparison of dimensional secondary outcome measures across the observation period, i.e. symptoms, functioning, quality of life, medication adherence, service engagement, and satisfaction with care, a series of Mixed Models Repeated Measures (MMRM) analyses will be specified (Mallinckrodt et al. 2001, 2004). This likelihood-based repeated measures approach, which is similar to a repeated measure ANOVA, has proven to be superior to e.g. last observation carried forward ANOVA in simulation scenarios patterned after acute phase neuropsychiatric clinical trials (Mallinckrodt et al. 2001, 2004) and is actively employed in schizophrenia research (Kennedy et al. 2003). Health economics will be analyzed according to the method of Knapp et al. (2008) using Quality-Adjusted Life Years (QALYs).

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Countries

Germany

Contacts

Public ContactMartin Lambert

Psychosen-Zentrum, Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf

lambert@uke.uni-hamburg.de040741057670

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026