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Behavioral Activation - From Inpatient to Outpatient Services

Psychotherapy in the Transition From Acute Psychiatric Inpatient Wards to Outpatient Services - A Randomized Controlled Trial of Behavioral Activation vs. Supportive Therapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01786733
Enrollment
64
Registered
2013-02-08
Start date
2013-03-31
Completion date
2017-04-30
Last updated
2017-05-03

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

Conditions

Depressive Symptoms, Inpatient Facility Diagnoses, Psychiatric Disorders

Keywords

Acute Inpatient Psychiatry, Continuity of Care, Behavioral Activation, Depression

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.

Interventions

BEHAVIORALBehavioral Activation
BEHAVIORALSupportive Therapy

Sponsors

Uppsala University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)Weekly during treatment period of 6 weeksMADRS-S is a 9 item self report measure of depressive symptoms.

Secondary

MeasureTime frameDescription
Change from baseline in Alcohol Disorders Identification Test (AUDIT)24 hours10 item screening instrument for alcohol use
Change from baseline in The Sheehan Disability Scale (SDS)24 hoursThe SDS is a three-item, self-report scale used to assess functioning in three areas of life (work, social life, and family life). Each item is rated on an 11-point Likert-type scale ranging from zero (no impairment) to 10 (extreme impairment), while the total range extends from zero to 30 points.
Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)24 hours9 item self rating instrument of activation and avoidance.
Change from baseline in sick leave and employment status6 monthsInterview questions regarding Days on/type of/level of sick leave Interview questions regarding employment status and hours of work per week
Change from baseline in EuroQol 5 Dimension Scale (EQ5D)24 hoursThe EQ5D is a self rating measure for health-related quality of life. It consists of 5 health state dimensions (mobility, self-care, usual activity, pain/discomfort and anxiety/depression) on which the respondent has to indicate his own health state.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)24 hoursInterview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.
Change from baseline in Global Assessment of Functioning (GAF)24 hoursClinicians and patients rate severity of symptoms and functioning on a scale ranging from 1-100.
Change from baseline in Clinical Global Impression (CGI)24 hoursClinician rates patients' psychiatric problems in regards to severity on a scale from 0-6. After treatment the clinician rates the degree of change in relation to the first assessment.
Change from baseline in Usage of mental health care6 monthsRe-admissions (frequency/length of admissions), outpatient visits, usage of psychiatric medications. Data from medical charts.
Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)24 hoursThe Mini International Neuropsychiatric Interview is a short, structured interview designed for clinicians to diagnose psychiatric disorders in accordance with the Diagnostic and Statistical Manual (DSM-IV) and International Classification of Diseases (ICD-10).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026