Clinical trial NCT03238872: Trial of Prompt Mental Health Care
Official title: Randomized Controlled Trial of Prompt Mental Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Mild to Moderate Depression
Keywords: Anxiety
Depression
CBT
Outcome monitoring
Dissemination
Routine services
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: The Research Council of Norway
name: University of Bergen
name: Göteborg University
name: Sussex Partnership NHS Foundation Trust
First posted: 2017-08-03
Enrollment: 774
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anxiety and depression are among the most common mental disorders in the population. Anxiety and depression have significant consequences at the individual, family and community level, and mental illness is estimated to cost the Norwegian society 180 billion Norwegian kroner annually. The majority of this amount is accounted for by anxiety and depression disorders. Meanwhile, access to mental health services to treat these disorders is limited. The proportion of people who do not receive treatment of those who are in need of treatment is estimated to be over 50%.

Prompt Mental Health Care (PMHC) is a pilot project initiated in 2012 by the Directorate of Health commissioned by the Ministry of Health, with the goal of increasing access to evidence-based treatment for adults with anxiety disorders and mild-to-moderate levels of depression. The treatment offered is cognitive behavioural therapy and should lead to reduced levels of symptoms of anxiety and depression, improved quality of life and better employability. PMHC is based on the English program "Improving Access to Psychological Therapy (IAPT)", which is established in virtually all health communities in England.

The evaluations of IAPT and PMHC have until now been based on relatively weak research designs which make it difficult to know to what extent the initiative really has the desired effect. In this study, PMHC is compared with a control group that receives treatment as usual (often provided by the general practioner) in two PMHC pilot sites (Kristiansand and Sandnes). Participants are randomly assigned to either the PMHC or the control group. The investigators aim to include 1100 clients in the study.

The key objectives of this study are to investigate whether PMHC treatment is more effective as compared to treatment in the control group with regard to symptoms of anxiety and depression, work participation, functional status, and mental well-being. Cost-effectiveness of PMHC is also examined.


Eligibility criteria: Inclusion Criteria:

* PHQ-9/GAD-7 scores above cut off Level
* Being above 18 years of age and a resident in the pilot sites
* Basic verbal and oral Norwegian proficiency

Exclusion Criteria:

* Entitled to secondary care services due to eating disorder, suicide risk, bipolar disorder, severe depression, invaliding anxiety, psychotic symptoms, severe substance abuse, and personality disorder.
* Two or more previous treatment attempts without effect.
* Serious physical health problem as prime problem

Primary outcomes:
measure: Recovery rate
timeFrame: Baseline to 6-month follow-up
measure: Changes in mean levels of depression and anxiety
timeFrame: Baseline to 6-month follow-up
Secondary outcomes:
measure: Recovery rate / Changes in mean levels of depression and anxiety at 12-month follow-up
timeFrame: Baseline to 12-month follow-up
measure: Recovery rate / Changes in mean levels of depression and anxiety at 24-month and 36-month follow-up, experimental group only.
timeFrame: Baseline to 24/36-month follow-up
measure: Work participation
timeFrame: Baseline to 12-month follow-up
measure: Functional status
timeFrame: Baseline to 12-month follow-up; for experimental group to 36-month follow-up.
measure: Health-related quality of life
timeFrame: Baseline to 12-month follow-up; for experimental group to 36-month follow-up.
measure: Mental Well-being
timeFrame: Baseline to 12-month follow-up; for experimental group to 36-month follow-up.
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Rask Psykisk Helsehjelp Kristiansand
city: Sandnes
country: Norway
facility: Rask Psykisk Helsehjelp Sandnes
Study officials:
affiliation: Norwegian Institute of Public Health
name: Robert Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lervik LV, Hoffart A, Knapstad M, Smith ORF. Exploring the temporal associations between avoidance behavior and cognitions during the course of cognitive behavioral therapy for clients with symptoms of social anxiety disorder. Psychother Res. 2022 Feb;32(2):195-208. doi: 10.1080/10503307.2021.1930243. Epub 2021 Jun 18.
citation: Knapstad M, Smith ORF. Social anxiety and agoraphobia symptoms effectively treated by Prompt Mental Health Care versus TAU at 6- and 12-month follow-up: Secondary analysis from a randomized controlled trial. Depress Anxiety. 2021 Mar;38(3):351-360. doi: 10.1002/da.23132. Epub 2021 Jan 4.