Skip to main content
Clinical Trials/NCT01786733
NCT01786733
Completed
Not Applicable

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

Uppsala University0 sites64 target enrollmentMarch 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inpatient Facility Diagnoses
Sponsor
Uppsala University
Enrollment
64
Primary Endpoint
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
April 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Uppsala University
Responsible Party
Principal Investigator
Principal Investigator

Fredrik Folke

PhD-student

Uppsala University

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

Outcomes

Primary Outcomes

Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)

Time Frame: 12 months

Secondary Outcomes

  • Change from baseline in Global Assessment of Functioning (GAF)(12 months)
  • Change from baseline in The Sheehan Disability Scale (SDS)(12 months)
  • Change from baseline in EuroQol 5 Dimension Scale (EQ5D)(12 months)
  • Change from baseline in sick leave and employment status(12 months)
  • Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)(12 months)
  • Change from baseline in Clinical Global Impression (CGI)(12 months)
  • Change from baseline in Alcohol Disorders Identification Test (AUDIT)(12 months)
  • Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)(12 months)
  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)(12 months)
  • Change from baseline in Usage of mental health care(12 months)

Similar Trials