Ostrobothnia Depression Study (ODS). A Naturalistic Follow-up Study on Depression and Related Substance Use Disorders
Condition: Major Depression; Dual Diagnosis; Anxiety Disorders; Substance Related Disorders
MeSH terms: Substance-Related Disorders; Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      Ostrobothnia Depression Study (ODS) was conducted in the South Ostrobothnia hospital district
      of Finland during 2009-2014. ODS is a naturalistic, open label, non-randomized follow-up
      study on depression and related substance use disorders (SUD). The study focuses on several
      aspects concerning the relation of depression and SUDs, the efficacy of selected assessment
      and treatment protocols, characteristics and genetics of the participants and the use of
      related biomarkers in clinical practice. The misused substance in focus is alcohol. In this
      study, dual diagnosis (DD) is defined as the simultaneous presence of clinically diagnosed
      major depressive disorder (MDD) and alcohol use disorder (AUD). The study was approved by the
      local ethics committee. Written informed consent was collected from all participants.
    

Detailed description: 
      Participants The participants were recruited in five outpatient clinics and in one
      psychiatric hospital ward in the South Ostrobothnia hospital district (population 200,000)
      during 1.10.2009 - 31.10.2013. Patients referred to psychiatric secondary services because of
      depressive symptoms, anxiety, self destructiveness, insomnia and alcohol or other substance
      related problems were screened with Beck depression inventory (BDI, version 1A). Patients
      with BDI score ≥ 17 at the screening phase were recruited in the study. The patients with a
      likely or verified psychotic disorders (ICD-10, F2*.** diagnosis) or organic brain disease
      were excluded.

      A total of 242 patients were included in the study. Fifty-three (21.9%) patients were
      hospitalised at baseline. The participants were aged 17-64 years (mean 38.8 years, SD 12.2).
      Among the recruited were 148 females (61.2%) and 94 males (38.8%). The Mini International
      Neuropsychiatric Interview 5.0 (MINI) was made at the baseline to 219 patients.

      At baseline 203 (84%) patients were prescribed antidepressive medication, 81% of cases either
      SSRI or SNRI as primary antidepressant). Antipsychotic medication was prescribed to 66 (28%)
      patients.

      At the time of recruitment the participants were divided in two groups based on the AUDIT
      -score. The patients with baseline AUDIT-score ≥ 11 were categorized as patients with
      comorbid AUD and therefore dual diagnosis (DD+). The patients with AUDIT ≤ 10 were
      categorized as (DD-).

      The clinical psychiatric evaluation was performed by a psychiatrist or other trained
      professional using the Mini International Neuropsychiatric Interview 5.0 (MINI). The symptoms
      of MDD were assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS).

      The patients received medication if the need for medical treatment was assessed by the
      psychiatrist responsible of the treatment. The use of psychotropic medications was recorded.
      The choice of medication was left for the clinician in charge.

      All participants were also evaluated by three-dimensional model to select the following
      treatment intervention. The model has been developed by Kampman and Lassila in South
      Ostrobothnia hospital district and described in more detail in Finnish Medical Journal. The
      model was developed based on the need to have tools to better assess the patients with DD in
      clinical setting. The model can be used for defining the patients' problem according to three
      treatment related factors (diagnosis, substance use problem, level of functioning). The model
      consists of three dichotomous assessments each leading to score of 0 or 1 points according to
      difficulty of the problem. The factors assessed are 1) psychiatric diagnosis
      (non-psychotic/psychotic; 0/1 points), 2) difficulty of SUD (moderate/difficult; 0/1 points)
      and 3) patients level of functioning according to Global Assessment of Functioning (GAF)
      -scale (good functioning/poor functioning; 0/1 points). The given points are then added
      together to form an overall score from 0 points (modest DD problem) to 3 points (most
      difficult DD problem).

      Treatment interventions The treatment interventions included antidepressive medication (SSRI
      or other), Behavioral Activation therapy (BA) and FRAMES intervention, and Motivational
      interview (MI) In participants with AUDIT ≤ 10 (DD-) the intervention started with focus on
      depression (antidepressive medication and BA). In patients with AUDIT ≥ 11 (DD+) the
      intervention started with focus on AUD. If AUD was evaluated as moderate (duration less than
      2 years, most of the days sober during the last month) the first treatment selected could be
      either FRAMES or MI. If AUD was assessed to be severe (duration more than 2 years, active use
      most of the days during last month, poly-substance use, GAF < 50) the intervention was
      supposed to start with MI. The intervention was implemented by the staff person responsible
      of the appointments of certain patient (a nurse or a psychologist) who had received training
      for the use of selected interventions. The duration of MI was set to approximately 3 (2-5)
      appointments. The minimum duration of BA was set to 4 appointments.

      Follow-up The follow-up included appointments with clinical research nurse at 6, 12 and 24
      months points. During these appointments the severity of and the recovery from depression was
      evaluated by MADRS, alcohol use was evaluated by AUDIT, the information on substance use
      relapses was collected, and the MINI-interview was repeated at 12 months point. Additionally,
      the following information was collected: 15D-quality of life scale, GAF-scale, laboratory
      tests (at 6 months: a blood count, electrolytes, creatinine, liver function), Body Mass
      Index, waist, smoking status.
    

Intervention name(s): Behavioral Activation; Motivational Interview
Intervention type(s): Behavioral; Behavioral
Intervention description(s): BA consists of at least 4 intervention sessions with a focused, active working style by the therapist. The therapy initiation includes a focused interview targeting at determining 1-2 main problems, on which the therapy will be focused. Specific therapeutic methods for BA include the use ABC analysis, targeting at hitting the negative consequences of current problematic behavior and motivating for change. Further, recognizing the obstacles for change (TRAP) is the next method to be used. The therapist encourages the client for active behavioral monitoring through assigned homework during the therapy process. The final step and method used is strengthening the gained change (ACTION).; Motivational interview (MI) is a therapeutic intervention that focuses on resolving client ambivalence towards changing problematic behavior. MI involves a client-centered approach that encourages the client to develop his or her own motivation. The therapeutic alliance in MI is predominantly a partnership, rather than an expert/client dynamic.
MI has been studied primarily in addiction problems, but there are numerous reports of its efficacy in several chronic somatic conditions, and lifestyle problems.
Other intervention name(s): Behavioral Activation Therapy; Cognitive Behavioral Therapy; Motivational Interviewing
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Mood Disorders; Motivational Interview; Behavioral Activation