NCT03499080

Brief Summary

In 2015 the Norwegian government, after initiative from user organizations, decided to implement medication free inpatient treatment units. The goal is to secure real options to medication for psychiatric illness, and to gather experiences with medication free options. Freedom of choice is a main concern. The projects main aim is to study the outcome of medication free treatments of mental illness compared to treatment as usual, as well as characteristics of the treatment and the treatment population and why patients choose this treatment. Hereunder we aim to document who asks for these kinds of services and why, what kind of treatment they get, how they experience it, and how they respond to this kind of treatment. An important part will be to document whether the goal of increased freedom of choice between real treatment options is fulfilled. Research questions

  1. 1.Does medication free treatment differ from treatment as usual? Are there any unique characteristics of the patient group who asks for this kind of treatment? What kind of treatment do they receive during their stay? How do they experience this treatment in comparison to treatment as usual? How is this in relation to the goals about increased freedom of choice? Does use of medication change during and/or after medication free treatment?
  2. 2.Why do patients choose medication free treatment? What are their reasons? What experiences lead to this wish?
  3. 3.What is the outcome of medication free treatment compared to treatment as usual?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

March 23, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

May 14, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

4.9 years

First QC Date

March 23, 2018

Last Update Submit

August 26, 2022

Conditions

Mental Illness

Keywords

Medication free treatment, mental illness, outcome

Outcome Measures

Primary Outcomes (1)

  • Outcome Questionnaire-45 (OQ-45)

    This questionnaire was developed for tracking outpatients on a weekly basis. It measures symptom distress, interpersonal functioning and contentment with social role functioning, areas widely recognized as the essential ingredients of interest when assessing patient improvement. It is regarded suitable for patients with a wide range of diagnoses, sensitive to change over a short period of time, and brief and easy to administer (Lambert, Hansen, \& Finch, 2001).

    Filled out by patients at start of treatment, 1 time every week during the treatment program (typically 2 to 8 weeks), 1 time at end of treatment (typically at week 2-8) and at 6 months, 1 year, 2 years and 3 years

Secondary Outcomes (25)

  • The Working Alliance Inventory (WAI-SP)

    Filled out by patients at start of treatment, 1 time every week during the treatment program (typically 2 to 8 weeks), 1 time at end of treatment (typically at week 2-8) and at 6 months, 1 year, 2 years and 3 years

  • Beliefs about medicines questionnaire (BMQ)

    Filled out by patients at start of treatment, end of treatment (typically at week 2-8) and at 6 months, 1 year, 2 years and 3 years

  • INSPIRE measure of staff support for personal recovery

    Filled out by patients at start of treatment, end of treatment (typically at week 2-8) and at 6 months, 1 year, 2 years and 3 years

  • CollaboRATE

    Filled out by patients at start of treatment, end of treatment (typically at week 2-8) and at 6 months, 1 year, 2 years and 3 years

  • The Client Satisfaction Questionnaire-8 (CSQ-8)

    Filled out by patients at start of treatment, end of treatment (typically at week 2-8) and at 6 months, 1 year, 2 years and 3 years

  • +20 more secondary outcomes

Study Arms (3)

Patients in medication free treatment

Inpatient unit dedicated to medication free treatment. This is an inpatient treatment unit for voluntary, planned treatment. The unit is staffed for a patient group that can be managed within a regime of open doors, voluntary treatment and low supervision. This means that high suicidal risk, severe acting out, active drug abuse etc. is excluded. They have an 8 week treatment program including Illness managment an recovery (IMR), Feedback informed treatment (FIT) and Affect consciousness treatment (ABT).

Behavioral: Medication free treatment

Patients in treatment as Usual Åråsen

Inpatient unit colocated with the medication free unit. Same level of care. Similar treatment program, shorter treatment duration (on average 3 weeks).

Behavioral: Treatment as usual Åråsen

Patients in treatment as Usual Myrvegen

Inpatient unit on a different location from the others. Same Level of care. Different treatment program. Intermediate treatment duration (mainly 4-6 weeks).

Behavioral: Treatment as usual Myrvegen

Interventions

Medication free treatmentBEHAVIORAL

Inpatient unit dedicated to medication free treatment. This is an inpatient treatment unit for voluntary, planned treatment. The unit is staffed for a patient group that can be managed within a regime of open doors, voluntary treatment and low supervision. This means that high suicidal risk, severe acting out, active drug abuse etc. is excluded. They have an 8 week treatment program including Illness managment an recovery (IMR), Feedback informed treatment (FIT) and Affect consciousness treatment (ABT).

Patients in medication free treatment
Treatment as usual MyrvegenBEHAVIORAL

Inpatient unit on a different location from the others. Same Level of care. Different treatment program. Intermediate treatment duration (mainly 4-6 weeks).

Patients in treatment as Usual Myrvegen
Treatment as usual ÅråsenBEHAVIORAL

Unit colocated with the medication free unit. Similar treatment program. Short treatment duration (average 3 weeks).

Patients in treatment as Usual Åråsen

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with mental illness in the regions Øvre and Nedre Romerike who receive medication free treatment or treatment as usual at the same level of care (planned, voluntary inpatient treatment at DPS døgn) within the period from spring 2018 and 1-2 years forward, who are able to fill out forms / be interviewed in Norwegian and concent to participate.

You may qualify if:

  • Receiving planned treatment in the included treatment units
  • Are able to fill out questionnaires in Norwegian with minimal help / be interviewed in norwegian
  • Signed informed consent and willing to participate in the trial

You may not qualify if:

  • Not able to fill out questionnaires or be interviewed in Norwegian.
  • Beds dedicated acute crisis and usercontrolled beds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

DPS Øvre Romerike Døgn

Jessheim, 2050, Norway

Location

DPS Nedre Romerike døgn

Lillestrøm, 2007, Norway

Location

Related Publications (22)

  • Aksjon for medisinfrie tilbud. www.medisinfrietilbud.no. Retrieved from http://medisinfrietilbud.no

    BACKGROUND

  • Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8.

    PMID: 21818162BACKGROUND

  • Benchimol EI, Smeeth L, Guttmann A, Harron K, Moher D, Petersen I, Sorensen HT, von Elm E, Langan SM; RECORD Working Committee. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. PLoS Med. 2015 Oct 6;12(10):e1001885. doi: 10.1371/journal.pmed.1001885. eCollection 2015 Oct.

    PMID: 26440803BACKGROUND

  • Bentall, R. (2009). Doctoring the Mind. Why Psychiatric Treatments fail. London: Penguin Books.

    BACKGROUND

  • Forand, N. R., & DeRubeis, R. J. (2013). Combining medication and psychotherapyin the treatment of major mental disorders. In M. J. Lambert (Ed.), Bergin & Garfield's handbook of psychotherapy and behaviour change (6. ed., pp. 735-775). Hoboken, New Jersey: John Wiley & Sons inc.

    BACKGROUND

  • Gundersen, K. (2016). Medikamentfri psykiatri - eksperiment uten forskning. Aftenposten.

    BACKGROUND

  • Helse Sør-Øst. (2016). Overordnet protokoll for medisinfri behandling innen psykisk helsevern.

    BACKGROUND

  • Helsedirektoratet. (2009). Nasjonal retningslinje for diagnostisering og behandling av depresjon i primær- og spesialisthelsetjenesten. ( IS-1561).

    BACKGROUND

  • Helsedirektoratet. (2012). Nasjonal faglig retningslinje for utgreiing og behandling av bipolare lidingar (IS-1925). Helsedirektoratet.

    BACKGROUND

  • Helsedirektoratet. (2013). Nasjonal faglig retningslinje for utredning, behandling og oppfølging av personer med psykoselidelser ( IS-1957). Helsedirektoratet.

    BACKGROUND

  • Lambert, M. J. (2013). The efficacy and effectiveness of psychotherapy. In M. J. Lambert (Ed.), Bergin & Garfield's handbook of psychotherapy and behavior change (6. ed., pp. 169-219). Hoboken, New Jersey: John Wiley & sons, inc.

    BACKGROUND

  • Moncrieff, j. (2009). A straight talking Introduction to Psychiatric drugs. Herefordshire: PCCS Books.

    BACKGROUND

  • Røssberg, j. i. (2016, 13.06.16). Det er langt fra sikkert at det riktige er å innføre medisinfritt behandlingstilbud. Aftenposten.

    BACKGROUND

  • Røssberg, j. i., Andreassen, O. A., & Malt, U. (2016, 17.07.16). Medisinfrie tiltak for psykoselidelser er fortsatt et sjansespill. Aftenposten.

    BACKGROUND

  • Sohler N, Adams BG, Barnes DM, Cohen GH, Prins SJ, Schwartz S. Weighing the evidence for harm from long-term treatment with antipsychotic medications: A systematic review. Am J Orthopsychiatry. 2016;86(5):477-85. doi: 10.1037/ort0000106. Epub 2015 Dec 14.

    PMID: 26652608BACKGROUND

  • Wampold, B. E. (2001). The Great Psychotherapy Debate. Models, Methods and Findings (2 ed.). Mahwah, New Jersey: Lawrence Erlbaum Associates publishers.

    BACKGROUND

  • Wampold, B. E., & Imel, Z. E. (2015). The Great Psychotherapy Debate. The Evidence for what makes Psychotherapy work (2 ed.). New York, London: Routledge, Taylor &Francis Group.

    BACKGROUND

  • Whitaker, R. (2010/2014 (no)). En psykiatrisk epidemi. Illusjoner om psykiatriske legemidler. Oslo: Abstract forlag.

    BACKGROUND

  • Whitaker, R. (2016). The case against antipsychotics. A review of their long-term effect. Weblog: Mad in America

    BACKGROUND

  • Wunderink L, Nieboer RM, Wiersma D, Sytema S, Nienhuis FJ. Recovery in remitted first-episode psychosis at 7 years of follow-up of an early dose reduction/discontinuation or maintenance treatment strategy: long-term follow-up of a 2-year randomized clinical trial. JAMA Psychiatry. 2013 Sep;70(9):913-20. doi: 10.1001/jamapsychiatry.2013.19.

    PMID: 23824214BACKGROUND

  • Standal K, Solbakken OA, Saltyte Benth J, Abbass A, Heiervang KS. Are People Worse Off in a Mental Health Treatment Paradigm Where Medication Is Deemphasised? A Naturalistic Noninferiority Trial of an Initiative to Improve Patient Choice. Int J Soc Psychiatry. 2025 Nov 23:207640251390930. doi: 10.1177/00207640251390930. Online ahead of print.

    PMID: 41277153DERIVED

  • Standal K, Solbakken OA, Rugkasa J, Halvorsen MS, Abbass A, Wirsching C, Brakstad IE, Heiervang KS. Medication-Free Treatment in Mental Health Care How Does It Differ from Traditional Treatment? Patient Prefer Adherence. 2024 Feb 3;18:315-335. doi: 10.2147/PPA.S435610. eCollection 2024.

    PMID: 38327730DERIVED

MeSH Terms

Conditions

Mental Disorders

Interventions

Therapeutics

Study Officials

  • Kristin Heiervang, PhD

    Akershus universitetssykehus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher Psychologist Phd

Study Record Dates

First Submitted

March 23, 2018

First Posted

April 17, 2018

Study Start

May 14, 2018

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

August 29, 2022

Record last verified: 2022-08

Locations

NO(2)