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Completed

NCT Number: NCT01786733

Behavioral Activation - From Inpatient to Outpatient Services

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.

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Key information

Conditions

Inpatient Facility Diagnoses Behavior Behavioral Symptoms Depression Depressive Symptoms Mental Disorders Psychiatric Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Activation

Behavioral

Supportive Therapy

Behavioral

Primary outcomes

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

    Time frame: Weekly during treatment period of 6 weeks

    MADRS-S is a 9 item self report measure of depressive symptoms.

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

    Time frame: 24 hours

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

    Time frame: 6 months

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

    Time frame: 12 months

Secondary outcomes

  1. Change from baseline in EuroQol 5 Dimension Scale (EQ5D)

    Time frame: 24 hours

    The 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.

  2. Change from baseline in EuroQol 5 Dimension Scale (EQ5D)

    Time frame: 6 months

  3. Change from baseline in EuroQol 5 Dimension Scale (EQ5D)

    Time frame: 12 months

  4. Change from baseline in Alcohol Disorders Identification Test (AUDIT)

    Time frame: 24 hours

    10 item screening instrument for alcohol use

  5. Change from baseline in Alcohol Disorders Identification Test (AUDIT)

    Time frame: 6 months

    10 item screening instrument for alcohol use

  6. Change from baseline in Alcohol Disorders Identification Test (AUDIT)

    Time frame: 12 months

    10 item screening instrument for alcohol use

  7. Change from baseline in The Sheehan Disability Scale (SDS)

    Time frame: 24 hours

    The 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.

  8. Change from baseline in The Sheehan Disability Scale (SDS)

    Time frame: 6 months

  9. Change from baseline in The Sheehan Disability Scale (SDS)

    Time frame: 12 months

  10. Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)

    Time frame: 24 hours

    9 item self rating instrument of activation and avoidance.

  11. Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)

    Time frame: Weekly druing treatment period of 6 weeks

    9 item self rating instrument of activation and avoidance.

  12. Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)

    Time frame: 6 months

    9 item self rating instrument of activation and avoidance.

  13. Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)

    Time frame: 12 months

    9 item self rating instrument of activation and avoidance.

  14. Change from baseline in sick leave and employment status

    Time frame: 6 months

    Interview questions regarding Days on/type of/level of sick leave Interview questions regarding employment status and hours of work per week

  15. Change from baseline in sick leave and employment status

    Time frame: 12 months

  16. Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)

    Time frame: 24 hours

    The 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).

  17. Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)

    Time frame: 6 months

    The Mini International Neuropsychiatric Interview is a short, structured interview designed for clinicians to diagnose axel I DSM-IV and ICD-10 disorders.

  18. Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)

    Time frame: 12 months

    The Mini International Neuropsychiatric Interview is a short, structured interview designed for clinicians to diagnose axel I DSM-IV and ICD-10 disorders.

  19. Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: 24 hours

    Interview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.

  20. Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: 6 months

    Interview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.

  21. Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: 12 months

    Interview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.

  22. Change from baseline in Global Assessment of Functioning (GAF)

    Time frame: 24 hours

    Clinicians and patients rate severity of symptoms and functioning on a scale ranging from 1-100.

  23. Change from baseline in Global Assessment of Functioning (GAF)

    Time frame: 6 months

    Clinicians and patients rate severity of symptoms and functioning on a scale ranging from 1-100.

  24. Change from baseline in Global Assessment of Functioning (GAF)

    Time frame: 12 months

    Clinicians and patients rate severity of symptoms and functioning on a scale ranging from 1-100.

  25. Change from baseline in Clinical Global Impression (CGI)

    Time frame: 24 hours

    Clinician 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.

  26. Change from baseline in Clinical Global Impression (CGI)

    Time frame: 6 months

  27. Change from baseline in Clinical Global Impression (CGI)

    Time frame: 12 months

  28. Change from baseline in Usage of mental health care

    Time frame: 6 months

    Re-admissions (frequency/length of admissions), outpatient visits, usage of psychiatric medications. Data from medical charts.

  29. Change from baseline in Usage of mental health care

    Time frame: 12 months

    Re-admissions (frequency/length of admissions), outpatient visits, usage of psychiatric medications. Data from medical charts.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Feb 8, 2013
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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