NCT03238872

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
774

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

2 active sites

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

November 9, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

2.3 years

First QC Date

August 1, 2017

Last Update Submit

March 10, 2021

Conditions

AnxietyMild to Moderate Depression

Keywords

AnxietyDepressionCBTOutcome monitoringDisseminationRoutine services

Outcome Measures

Primary Outcomes (2)

  • Recovery rate

    Proportion of clients that have recovered based on predefined cut-offs for the Patient Health Questionnaire (PHQ\<10) and Generalized Anxiety Disorder scale (GAD\<8).

    Baseline to 6-month follow-up

  • Changes in mean levels of depression and anxiety

    Changes in mean levels of depression and anxiety as measured by respectively PHQ and GAD

    Baseline to 6-month follow-up

Secondary Outcomes (6)

  • Recovery rate / Changes in mean levels of depression and anxiety at 12-month follow-up

    Baseline to 12-month follow-up

  • Recovery rate / Changes in mean levels of depression and anxiety at 24-month and 36-month follow-up, experimental group only.

    Baseline to 24/36-month follow-up

  • Work participation

    Baseline to 12-month follow-up

  • Functional status

    Baseline to 12-month follow-up; for experimental group to 36-month follow-up.

  • Health-related quality of life

    Baseline to 12-month follow-up; for experimental group to 36-month follow-up.

  • +1 more secondary outcomes

Study Arms (2)

Prompt Mental Health Care

EXPERIMENTAL

Clients in the experimental group receive short-term cognitive behavioural therapy in the form of a psycho-educational group course, guided self-help, or individual face-to-face therapy.

Behavioral: Cognitive Behavioural Therapy

Treatment as usual

ACTIVE COMPARATOR

Clients in the comparison group are offered treatment as usual from their general practitioner.

Other: Treatment as usual

Interventions

Cognitive Behavioural TherapyBEHAVIORAL
Prompt Mental Health Care
Treatment as usualOTHER
Treatment as usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rask Psykisk Helsehjelp Kristiansand

Kristiansand, Norway

Location

Rask Psykisk Helsehjelp Sandnes

Sandnes, Norway

Location

Related Publications (4)

  • Andersen AIO, Knapstad M, Smith ORF. Can registry-based auxiliary variables improve handling of missing outcome data in mental health trials? Evidence from a registry-linked randomized study. Trials. 2025 Dec 9. doi: 10.1186/s13063-025-09346-z. Online ahead of print.

    PMID: 41366421DERIVED

  • Hanevik E, Rovik FMG, Boe T, Knapstad M, Smith ORF. Client predictors of therapy dropout in a primary care setting: a prospective cohort study. BMC Psychiatry. 2023 May 24;23(1):358. doi: 10.1186/s12888-023-04878-7.

    PMID: 37226210DERIVED

  • 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.

    PMID: 34142636DERIVED

  • 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.

    PMID: 33393688DERIVED

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Cognitive Behavioral TherapyTherapeutics

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Robert Smith, PhD

    Norwegian Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 3, 2017

Study Start

November 9, 2015

Primary Completion

March 1, 2018

Study Completion

September 30, 2020

Last Updated

March 15, 2021

Record last verified: 2021-03

Locations

NO(2)