NCT02520271

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 11, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

4 years

First QC Date

June 27, 2015

Last Update Submit

August 11, 2015

Conditions

Major DepressionDual DiagnosisAnxiety DisordersSubstance Related Disorders

Keywords

Mood DisordersMotivational InterviewBehavioral Activation

Outcome Measures

Primary Outcomes (1)

  • Change in severity of depressive symptoms from baseline at 6 weeks, 6 months, 12 months, and 24 months

    Measure: MADRS depression scale

    baseline, 6 weeks, 6 months, 12 months, 24 months

Secondary Outcomes (3)

  • Change in quality of life from baseline at 6 weeks, 6 months, 12 months, and 24 months

    baseline, 6 months, 12 months, 24 months

  • Change in number of weekly consumed alcohol drinks from baseline at 6 weeks, 6 months, 12 months, and 24 months

    baseline, 6 weeks, 6 months, 12 months, 24 months

  • Change in severity of alcohol use from baseline at 6 weeks, 6 months, 12 months, and 24 months

    baseline, 6 weeks, 6 months, 12 months, 24 months

Study Arms (2)

Depression

ACTIVE COMPARATOR

Behavioral activation only

Behavioral: Behavioral Activation

Depression and SUD

ACTIVE COMPARATOR

Motivational interview and Behavioral activation

Behavioral: Behavioral ActivationBehavioral: Motivational Interview

Interventions

Behavioral ActivationBEHAVIORAL

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).

Also known as: Behavioral Activation Therapy, Cognitive Behavioral Therapy
DepressionDepression and SUD
Motivational InterviewBEHAVIORAL

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.

Also known as: Motivational Interviewing
Depression and SUD

Eligibility Criteria

Age17 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients referred to psychiatric secondary services because of
  • Depressive symptoms
  • Anxiety
  • Self-destructiveness
  • Insomnia
  • Alcohol or other substance related problems, and had Beck depression inventory (BDI, version 1A) score at least 17 at the screening phase.

You may not qualify if:

  • A likely or verified ICD-10 F2 category diagnosis (psychotic disorders).
  • Organic brain disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seinäjoki Hospital District

Seinäjoki, South Ostrobothnia, 60220, Finland

Location

Related Publications (7)

  • Miller WR, Rollnick S. Ten things that motivational interviewing is not. Behav Cogn Psychother. 2009 Mar;37(2):129-40. doi: 10.1017/S1352465809005128.

    PMID: 19364414BACKGROUND

  • Kanter JW, Manos RC, Bowe WM, Baruch DE, Busch AM, Rusch LC. What is behavioral activation? A review of the empirical literature. Clin Psychol Rev. 2010 Aug;30(6):608-20. doi: 10.1016/j.cpr.2010.04.001.

    PMID: 20677369BACKGROUND

  • Kampman O, Lassila A. Samanaikaisen mielenterveys- ja päihdeongelman hoitoon on kehitetty integroitu arviointimalli [TI: An Integrated Assessment Method for Dual Diagnosis]. Suom Lääkäril 2007:4447-4451.[SO: Finnish Medical Journal, Finnish]

    BACKGROUND

  • Luoto KE, Lassila A, Leinonen E, Kampman O. Predictors of short-term response and the role of heavy alcohol use in treatment of depression. BMC Psychiatry. 2023 Nov 27;23(1):880. doi: 10.1186/s12888-023-05366-8.

    PMID: 38012573DERIVED

  • Archer M, Niemela O, Hamalainen M, Moilanen E, Leinonen E, Kampman O. The role of alcohol use and adiposity in serum levels of IL-1RA in depressed patients. BMC Psychiatry. 2022 Mar 2;22(1):158. doi: 10.1186/s12888-022-03784-8.

    PMID: 35232419DERIVED

  • Luoto KE, Lindholm LH, Koivukangas A, Lassila A, Sintonen H, Leinonen E, Kampman O. Impact of Comorbid Alcohol Use Disorder on Health-Related Quality of Life Among Patients With Depressive Symptoms. Front Psychiatry. 2021 Oct 8;12:688136. doi: 10.3389/fpsyt.2021.688136. eCollection 2021.

    PMID: 34690824DERIVED

  • Luoto KE, Lindholm LH, Paavonen V, Koivukangas A, Lassila A, Leinonen E, Kampman O. Behavioral activation versus treatment as usual in naturalistic sample of psychiatric patients with depressive symptoms: a benchmark controlled trial. BMC Psychiatry. 2018 Jul 27;18(1):238. doi: 10.1186/s12888-018-1820-x.

    PMID: 30049272DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorAnxiety DisordersSubstance-Related DisordersMood Disorders

Interventions

Cognitive Behavioral TherapyMotivational Interviewing

Condition Hierarchy (Ancestors)

Depressive DisorderMental DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesDirective CounselingCounselingMental Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Olli Kampman, MD, PhD

    Seinäjoki Hospital District, Department of Psychiatry and University of Tampere, School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 27, 2015

First Posted

August 11, 2015

Study Start

October 1, 2009

Primary Completion

October 1, 2013

Study Completion

June 1, 2014

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

FI(1)