Clinical trial NCT01786733: Behavioral Activation - From Inpatient to Outpatient Services
Official title: Psychotherapy in the Transition From Acute Psychiatric Inpatient Wards to Outpatient Services - A Randomized Controlled Trial of Behavioral Activation vs. Supportive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inpatient Facility Diagnoses
Psychiatric Disorders
Depressive Symptoms
Keywords: Acute Inpatient Psychiatry
Continuity of Care
Behavioral Activation
Depression
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of Behavioral Activation and Supportive Therapy added to the standard acute psychiatric inpatient care. Therapy starts during inpatient care and can continue in an outpatient facility if the patients are discharged before 12 sessions has been completed.

Detailed description: Psychiatric inpatient care is reserved for individuals with the most acute mental health problems. The period after discharge is associated with increased risk for relapse, non-adherence and suicide. Delivering high quality psychosocial interventions during and after acute psychiatric inpatient care is known to be a difficult challenge. This study will investigate the effectiveness of adding either Behavioral Activation or Supportive Therapy to the standard acute psychiatric inpatient care. Subjects with different psychiatric diagnoses and elevated depressive symptoms are assessed and randomized after admission. Therapists from the nearest outpatient facility initiate 12 sessions of Behavioral Activation or Supportive Therapy as soon as possible. The 12 sessions are delivered twice weekly at the inpatient unit or at the outpatient facility, depending on whether the patient is admitted or discharged. Treatment as usual interventions(medications, nursing etc.) are not manipulated in the study. The main assessment points are pre-, post, 6 months follow-up and 12 months follow-up. The main outcome measure and some process measures are also administered at session 3, 6 and 9.

Eligibility criteria: Inclusion Criteria:

* Admitted into one of four acute psychiatric inpatient units in Dalarna
* MADRS-S 20 and above at acute admission and and after 2-3 days on the ward
* Psychiatric disorder according to M.I.N.I (Sheehan et al., 1998)
* Read and Speak Swedish

Exclusion Criteria:

* Acute psychotic symptoms
* Acute manic symptoms
* Confusion
* Primary eating disorder
* Primary alcohol or substance abuse disorder
* Self rated score on AUDIT (Saunders et al., 1993)of 20 or greater
* Mental retardation

Primary outcomes:
measure: Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)
timeFrame: Weekly during treatment period of 6 weeks
measure: Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)
timeFrame: 24 hours
measure: Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)
timeFrame: 6 months
measure: Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline in EuroQol 5 Dimension Scale (EQ5D)
timeFrame: 24 hours
measure: Change from baseline in EuroQol 5 Dimension Scale (EQ5D)
timeFrame: 6 months
measure: Change from baseline in EuroQol 5 Dimension Scale (EQ5D)
timeFrame: 12 months
measure: Change from baseline in Alcohol Disorders Identification Test (AUDIT)
timeFrame: 24 hours
measure: Change from baseline in Alcohol Disorders Identification Test (AUDIT)
timeFrame: 6 months
measure: Change from baseline in Alcohol Disorders Identification Test (AUDIT)
timeFrame: 12 months
measure: Change from baseline in The Sheehan Disability Scale (SDS)
timeFrame: 24 hours
measure: Change from baseline in The Sheehan Disability Scale (SDS)
timeFrame: 6 months
measure: Change from baseline in The Sheehan Disability Scale (SDS)
timeFrame: 12 months
measure: Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
timeFrame: 24 hours
measure: Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
timeFrame: Weekly druing treatment period of 6 weeks
measure: Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
timeFrame: 6 months
measure: Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)
timeFrame: 12 months
measure: Change from baseline in sick leave and employment status
timeFrame: 6 months
measure: Change from baseline in sick leave and employment status
timeFrame: 12 months
measure: Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)
timeFrame: 24 hours
measure: Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)
timeFrame: 6 months
measure: Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)
timeFrame: 12 months
measure: Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 24 hours
measure: Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 6 months
measure: Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 12 months
measure: Change from baseline in Global Assessment of Functioning (GAF)
timeFrame: 24 hours
measure: Change from baseline in Global Assessment of Functioning (GAF)
timeFrame: 6 months
measure: Change from baseline in Global Assessment of Functioning (GAF)
timeFrame: 12 months
measure: Change from baseline in Clinical Global Impression (CGI)
timeFrame: 24 hours
measure: Change from baseline in Clinical Global Impression (CGI)
timeFrame: 6 months
measure: Change from baseline in Clinical Global Impression (CGI)
timeFrame: 12 months
measure: Change from baseline in Usage of mental health care
timeFrame: 6 months
measure: Change from baseline in Usage of mental health care
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: The Adult Psychiatric Clinic of Landstinget Dalarna, Sweden
name: Per Söderberg, PhD
role: STUDY_DIRECTOR
affiliation: Department of Neuroscience, Psychiatry, Uppsala University, Sweden
name: Lisa Ekselius, Professor
role: STUDY_CHAIR
affiliation: The Adult Psychiatric Clinic of Landstinget Dalarna, Sweden
name: Stefan Tungström, PhD
role: STUDY_CHAIR
affiliation: The Department of Psychology, Uppsala University, Sweden
name: Timo Hursti, PhD
role: STUDY_CHAIR
affiliation: Department of Neuroscience, Psychiatry, Uppsala University, Sweden
name: Fredrik Folke, PhD-student
role: PRINCIPAL_INVESTIGATOR
References: