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AnxietyNCT03238872

Trial of Prompt Mental Health Care

A study testing Cognitive Behavioural Therapy and Treatment as usual in people with Anxiety and Mild to Moderate Depression, run by Norwegian Institute of Public Health at 2 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anxiety, Mild to Moderate Depression
What is being tested?
Cognitive Behavioural Therapy and Treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
774 participants
Where
2 sitesNorway
Study dates
9 Nov 2015to 30 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Norway2 sites

  • Rask Psykisk Helsehjelp Kristiansand

    Kristiansand

  • Rask Psykisk Helsehjelp Sandnes

    Sandnes

Other trials in Norway

About this study

Official title: Randomized Controlled Trial of Prompt Mental Health Care

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.

Read more

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.

Being tested
Cognitive Behavioural Therapy, Treatment as usual
Keywords
Anxiety, Depression, CBT, Outcome monitoring, Dissemination, Routine services
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03238872
Study groupRoleWhat they receive
Prompt Mental Health CareExperimentalClients 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.
Receives: Behavioral: Cognitive Behavioural Therapy
Treatment as usualActive comparatorClients in the comparison group are offered treatment as usual from their general practitioner.
Receives: Other: Treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline to 6-month follow-up

  2. Changes in mean levels of depression and anxiety

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

    Measured: Baseline to 6-month follow-up

Secondary outcomes (6)

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

    Measured: Baseline to 12-month follow-up

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

    Measured: Baseline to 24/36-month follow-up

  3. Work participation

    Increased or maintained work participation at 6 and 12 month follow-up, defined as maintained work participation, new employment or a full or partial return-to-work. Both questionnaire and registry-based data are used for this purpose.

    Measured: Baseline to 12-month follow-up

  4. Functional status

    Changes in mean levels of functional status as measured by the Work and Social Adjustment Scale (WSAS).

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

  5. Health-related quality of life

    Changes in mean levels of health-related quality of life as measured by the EuroQoL-5D (EQ-5D).

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

  6. Mental Well-being

    Changes in mean levels of mental well-being as measured by the Warwick Edinburgh Mental Well-Being Scale (WEMWBS).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2017
  2. Study start9 Nov 2015
  3. Primary completion1 Mar 2018
  4. Study completion30 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
774 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03238872
Sponsor's protocol ID
260659
Status last verified
Mar 2021
First submitted
1 Aug 2017
Last updated
15 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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;27(1):33. doi: 10.1186/s13063-025-09346-z.

    PubMed 41366421

  • 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.

    PubMed 37226210

  • 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.

    PubMed 34142636

  • 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.

    PubMed 33393688

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioural Therapy and Treatment as usual in people with Anxiety and Mild to Moderate Depression, run by Norwegian Institute of Public Health at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recovery rate (time frame: Baseline to 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03238872, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.

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