Behavioral Activation - From Inpatient to Outpatient Services

NCT ID: NCT01786733

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2017-04-30

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.

Conditions

Inpatient Facility Diagnoses; Psychiatric Disorders; Depressive Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Behavioral Activation

Behavioral Activation + Treatment as Usual. 12 sessions twice weekly (i.e. 6 weeks). Individual therapy. Therapy is initiated during inpatient admission and continue after discharge. Protocol aimed at increased activation towards goals and personal values and decreased avoidance behaviors.

Group Type: EXPERIMENTAL

Behavioral Activation

Intervention Type: BEHAVIORAL

Supportive Therapy

Supportive Therapy + Treatment as Usual. 12 sessions twice weekly (i.e. 6 weeks). Individual therapy. Therapy is initiated during inpatient admission and continue after discharge. Protocol aimed at providing psychological non-directive support.

Group Type: ACTIVE_COMPARATOR

Supportive Therapy

Intervention Type: BEHAVIORAL

Interventions

Behavioral Activation

Intervention Type: BEHAVIORAL

Supportive Therapy

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Fredrik Folke

PhD-student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Per Söderberg, PhD

Role: STUDY_DIRECTOR

The Adult Psychiatric Clinic of Landstinget Dalarna, Sweden

Lisa Ekselius, Professor

Role: STUDY_CHAIR

Department of Neuroscience, Psychiatry, Uppsala University, Sweden

Stefan Tungström, PhD

Role: STUDY_CHAIR

The Adult Psychiatric Clinic of Landstinget Dalarna, Sweden

Timo Hursti, PhD

Role: STUDY_CHAIR

The Department of Psychology, Uppsala University, Sweden

Fredrik Folke, PhD-student

Role: PRINCIPAL_INVESTIGATOR

Department of Neuroscience, Psychiatry, Uppsala University, Sweden

Other Identifiers

Dnr 2012 / 226

Identifier Type: -

Identifier Source: org_study_id