Clinical trial NCT03499080: Medication Free Treatment: Characteristics, Justification and Outcome
Official title: Medication Free Treatment: Characteristics, Justification and Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Illness
Keywords: Medication free treatment, mental illness, outcome
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2018-04-17
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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. 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. Why do patients choose medication free treatment? What are their reasons? What experiences lead to this wish?
3. What is the outcome of medication free treatment compared to treatment as usual?

Detailed description: Background 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. (Aksjon for medisinfrie tilbud) The local unit under study DPS døgn Moenga at Akershus University Hospital has been given the assignment of developing a medication free treatment unit. This is an inpatient treatment unit for voluntary, planned treatment. High suicidal risk, severe acting out, active drug abuse etc. is excluded. The treatment program is 8 weeks long.

Status of knowledge The project has been controversial, especially with reference to the status of knowledge. Critiques have stated that the knowledge base for treating serious psychiatric disorders without medication is lacking (Gundersen, 2016; Røssberg, 2016). Concerns are raised about whether it can be harmful (Røssberg, 2016), whether it is necessary (Røssberg, Andreassen, \& Malt, 2016) and whether it creates unfortunate dividing lines within health care (Røssberg et al., 2016). National guidelines recommend considering/offering medication for bipolar disorders, deep depression and psychosis (Helsedirektoratet, 2009, 2012, 2013). On the other hand, the knowledge base for use of psychotropic drugs is also being questioned, especially regarding long term effects (Bentall, 2009; Forand \& DeRubeis, 2013; Moncrieff, 2009; Sohler et al., 2016; Whitaker, 2010/2014 (no), 2016). Studies on medication are amongst others criticized for not taking withdrawal effect sufficiently into account (Bentall, 2009; Forand \& DeRubeis, 2013; Moncrieff, 2009; Whitaker, 2010/2014 (no), 2016). A randomized controlled study by Wunderink, Nieboer, Wiersma, Sytema, and Nienhuis (2013) indicates a follow up period of at least 3 years is necessary to see the benefits of drug reduction regarding antipsychotics.

Summing up, one can argue that generally, a considerable research base point to psychosocial treatment methods having an important place in the treatment of most psychiatric problems (Lambert, 2013; Wampold, 2001; Wampold \& Imel, 2015). The more specific questions regarding pure psychosocial treatment for serious disorders and long term effects of psychotropic drugs are at least disputable, and probably under-researched.

Research questions

1. Does medication free treatment differ from treatment as usual? Patient characteristics, treatment received, experience, medication use.
2. Why do patients choose medication free treatment? What are their reasons? What experiences lead to this wish?
3. What is the outcome of medication free treatment compared to treatment as usual? Hypotheses The treatment outcome of medication free treatment is not inferior to treatment as usual.

Patients in medication free treatment will use less medication. Medication withdrawal may affect outcome in the short run.

Project methodology The design of the study is a mixed methods, observational design within a naturalistic treatment setting using qualitative and quantitative methods to address the research questions.

Moenga consist of two units, the medication free unit and a regular unit, which will be included for comparison. In addition we include a treatment unit on a different location for comparison; DPS Myrvegen. We aim for at least 200 n.

One complication is that this autumn it was decided that the units at Moenga shall move and reorganize sometime during 2018. This entail change of location, possible reorganizing of personnel and that the comparison unit at Moenga is joined with another inpatient unit at the new location. This may cause disruptions that can affect our results. We will study possible effects of this in our data, and may exclude parts of the gathered data and prolong the inclusion period.

We will collect survey data at start of treatment, weekly during treatment, at end of treatment (Work package 1), and at 6 months, 1 year, 2 years and 3 years follow up (work package 3). Register data will be collected 3 years back and 3 years follow up (work package 3). Patient interviews (work package 2) and personnel interviews (work package 4) are performed during spring 2018, the patient interviews near the end of the treatment stay. See measures for details.

Plan for data analyses Quantitative and qualitative analyses will be done according to the research questions. We will seek to compare the medication free unit and treatment as usual. Calculating propensity scores in the observational part of the study will be considered, to balance comparison groups (Austin, 2011).

Statistical power Exact power calculations are only possible in concrete, delimited statistical designs, and must necessarily be based on assumptions not always known before starting the study. In a design with 200 persons the total effect of one-way analysis of variance yield a statistical power of .80 for small to medium effect sizes. That is, the probability of detecting differences between groups will be .80 for effect sizes in the range .40 -.50. For pairwise comparisons between groups (with N=50), the probability of detecting effects in the range of Cohen's d \>=. 40 will be about .80. In Cohen's pragmatic system, effect sizes with such magnitudes represent a "small to medium effect size". These estimations will also apply to change-scores between two points in time, given that the correlation between the two repeated measurements are r \>= .5.

Study plan

Data collection:

Work package 1: Inclusion of patients for quantitative measurements starts April 2018 with a 12 months inclusion period. This may be prolonged if necessary.

Work package 2: Patient interviews will be performed during spring 2018. Work package 3: Follow up measures and register data will be collected until spring 2022.

Work package 4: Personnel interviews will be performed during spring 2018. Analysis Qualitative analyses will be performed within end of 2018. Quantitative analyses will start January 2019 Publishing Publishing of the results in scientific papers will take place mainly in 2019-2023.

Articles

1. "Medication free treatment: Does it differ from treatment as usual?" This article will address research question 1 and include qualitative data, Collaborate, BMQ, Inspire, CSQ-8, WAI, treatment received, use of medication and background data.
2. "Medication free treatment: Why?" This article will address research question 2 (Why do patients choose medication free treatment) and include qualitative data.
3. "Medication free treatment: Does it work?" This article will address the research questions and will include the outcome measures OQ-45, AII, Quality of life, HoNOs, GAF, CGI, drug use, diagnoses and register data. We will also look for correlations between use of medication and outcome, and therefore include measures of medication use.

Research group PhD Kristin S. Heiervang, head of the research group Quality and implementation in Mental Health Services at Akershus university hospital, is project manager (principal investigator) for the project.

Anders S. Wenneberg, specialist in clinical psychology, is the leader of the inpatient treatment facility. Wenneberg is also the project manager of the "Medication Free Treatment" at Akershus University Hospital, Moenga.

Ole André Solbakken is associate professor of clinical psychology and head of section at the Department of Psychology, University of Oslo.

Odd Arne Tjersland is professor of clinical psychology at the Department of Psychology, University of Oslo.

Jon T. Monsen is professor of clinical psychology at the Department of Psychology, University of Oslo.

Allan Abbass is professor, psychiatrist, and founding Director of the Centre for Emotions and Health at Dalhousie University in Halifax, Canada.

Kari Standal will be the PhD candidate. She is a psychologist at Akershus university hospital, specialized in adult treatment and psychotherapy (group treatment and affect consciousness).

Jill Arild, board member of "Mental Helse" and leader of the action group for medication free treatment is user represantive in the project.

Astrid Ringen Martinsen is a psychology student who will write her main thesis on the qualitative patient data.

Ingrid Engeseth Brakstad is a psychology student who will write her main thesis on the qualitative personnel data.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Outcome Questionnaire-45 (OQ-45)
timeFrame: 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:
measure: The Working Alliance Inventory (WAI-SP)
timeFrame: 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
measure: Beliefs about medicines questionnaire (BMQ)
timeFrame: 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
measure: INSPIRE measure of staff support for personal recovery
timeFrame: 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
measure: CollaboRATE
timeFrame: 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
measure: The Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: 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
measure: Affect Integration Inventory 42 (AII-42)
timeFrame: 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
measure: Life satisfaction question
timeFrame: 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
measure: Questions regarding whether they specifically sought medication free treatment and why
timeFrame: Filled out by patients at start of treatment.
measure: Background data
timeFrame: Filled out by patients at start of treatment.
measure: Treatment received
timeFrame: Filled out by patients at end of treatment (typically week 2-8).
measure: Use of drugs
timeFrame: Filled out by patients at start of treatment, at 6 months, 1 year, 2 years and 3 years
measure: The Clinical Global Impressions Scale (CGI)
timeFrame: Filled out by clinician at start of treatment and end of treatment (typically week 2-8)
measure: Health of the Nation Outcomes Scales (HoNOS)
timeFrame: Filled out by clinician at start of treatment and end of treatment (typically week 2-8).
measure: Global assessment of functioning (GAF)
timeFrame: Filled out by clinician at start of treatment and end of treatment (typically week 2-8).
measure: Scale on alcohol (AUS)
timeFrame: Filled out by clinician at start of treatment and end of treatment (typically week 2-8).
measure: Scale on drugs (DUS)
timeFrame: Filled out by clinician at start of treatment and end of treatment (typically week 2-8).
measure: Diagnoses
timeFrame: Filled out by clinician at start of treatment and end of treatment (typically week 2-8).
measure: Treatment received
timeFrame: Filled out by clinician at end of treatment (typically week 2-8).
measure: Patient interviews
timeFrame: The interviews will be done close to the end of the treatment program (typically week 7).
measure: Register data
timeFrame: Register data will be documented at baseline, and at 6 months, 1 year, 2 years and 3 years follow up.
measure: Staff interviews
timeFrame: The interviews are performed during spring 2018
measure: Register data from the Medication Prescription Register
timeFrame: Collected at 3 years before treatment start, 2 years before, 1 year before, 6 months post treatment, 1 year post treatment, 2 years post treatment and 3 years post treatment
measure: Questionnaire on medication filled out by patients
timeFrame: at start of treatment, at 6 monts, 1 year, 2 years and 3 years.
measure: Questionnaire on medication filled out by clinician
timeFrame: at start of treatment and end of treatment (typically at 2-8 weeks)
measure: Help with medication filled out by patient
timeFrame: at start of treatment, end of treatment (typically at 2-8 weeks) and at 6 months, 1 year, 2 years and 3 years.
Other outcomes:
Locations:
city: Jessheim
country: Norway
facility: DPS Øvre Romerike Døgn
city: Lillestrøm
country: Norway
facility: DPS Nedre Romerike døgn
Study officials:
affiliation: Akershus universitetssykehus
name: Kristin Heiervang, PhD
role: PRINCIPAL_INVESTIGATOR
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