Effectiveness of stepped care guided self-help followed by face-to-face cognitive behavioral therapy versus standalone internet-delivered or face-to-face cognitive behavioral therapy for anxiety
| ISRCTN | ISRCTN10064801 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10064801 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | VN/29619/2023, VN/29613/2023 |
| Sponsor | Helsinki University Hospital |
| Funder | Sosiaali- ja Terveysministeriö |
- Submission date
- 13/09/2024
- Registration date
- 20/09/2024
- Last edited
- 07/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Anxiety is one of the most common mental health conditions, especially in Western countries. Access to treatment, such as cognitive behavioral therapy (CBT), in publicly funded primary care settings is often inadequate. This study aims to evaluate the effectiveness and cost-effectiveness of three treatments for anxiety 1) A stepped care model: sequential guided self-help (GSH) followed by face-to-face CBT for non-responders 2) internet-delivered CBT (iCBT), and 3) face-to-face CBT, within the Finnish public healthcare.
Who can participate?
Adults (16+ yrs) experiencing anxiety symptoms (> 4 p on the GAD-7) who are suitable for step 1 or step 2 treatments (such as GSH, iCBT, or CBT) in the Finnish public healthcare system. Individuals who are already receiving psychological treatment, have severe suicidal thoughts, or have substance abuse issues may not be eligible.
What does the study involve?
Participants will be randomly assigned to one of three groups: face-to-face CBT, iCBT, or GSH. Those who do not respond adequately to GSH will be offered further treatment with face-to-face CBT. Participants will complete symptom measures, such as the Generalized Anxiety Disorder scale (GAD-7), and the Patient Health Questionnaire (PHQ-9) at various stages over the course of the study to track changes in their mental health.
What are the possible benefits and risks of participating?
The study aims to improve access to effective, evidence-based treatments for anxiety in public healthcare. All participants will receive treatment that is at least as good as the standard care they would receive outside the study. The potential risks are minimal and comparable to current treatment options, but if symptoms worsen, participants will be directed to appropriate care.
Where is the study run from?
The study will be conducted within several wellbeing service counties in Southern Finland and Western Finland. It is part of the Finnish First-Line Therapies –initiative in Finland’s public healthcare system.
When is the study starting and how long is it expected to run for?
The study is set to begin in autumn 2024, with recruitment expected to continue until summer 2026, with long-term follow-ups extending up to five years or more.
Who is funding the study?
The study is primarily funded by EU-Next Generation grants distributed from the Ministry of Social Affairs and Health in Finland (VN/29619/2023 and VN/29613/2023). Additional funding may be provided by HUS (Helsinki University Hospital) and other research foundations.
Who is the main contact?
Professor Suoma E. Saarni, MD, PhD, who serves as the principal investigator, is based at Helsinki University Hospital (HUS) and Tampere University, suoma.saarni@hus.fi
Contact information
Scientific, Principal investigator
HUS Psychiatry, Välskärinkatu 12
Helsinki
00029
Finland
 ORCID ID |
0000-0003-3555-9958 |
|---|---|
| Phone | +358 94711 |
| suoma.saarni@hus.fi |
Public
HUS Psychiatry, Välskärinkatu 12
Helsinki
00029
Finland
| Phone | +358 94711 |
|---|---|
| katariina.m.mattila@hus.fi |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled non-inferiority trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effectiveness and cost-effectiveness of stepped care guided self-help followed by face-to-face cognitive behavioral therapy versus standalone internet-delivered or face-to-face cognitive behavioral therapy for anxiety: a randomized controlled non-inferiority trial of the finnish first-line therapies–initiative |
| Study acronym | FLT-Step |
| Study objectives | Current study objectives as of 07/07/2025: Primary hypothesis P1. A stepped care model (sequential GSH followed by face-to-face cognitive behavioral therapy (CBT) for non-responders), and internet-delivered cognitive behavioral therapy (iCBT) are non-inferior (non-inferiority margin 1.7 points on the Generalized Anxiety Disorder scale, GAD-7) to CBT for treating clinical anxiety symptoms (baseline score of ≥10 on the GAD-7) at primary outcome measurement point (6 months after enrollment). Secondary hypotheses: S1. If non-inferiority is demonstrated, effectiveness of the stepped care model (sequential GSH followed by fCBT for non-responders) is superior compared to directly admitting patients to fCBT when treating clinical anxiety symptoms (baseline score of ≥10 p on GAD-7), assessed at six months after enrollment. S2a. Stepped care is more cost-effective than directing all patients with anxiety symptoms (baseline score ≥10 p on GAD-7) directly to fCBT assessed six months after enrollment. S2b: iCBT is more cost-effective than directing all patients with anxiety symptoms (baseline score of ≥10 p on GAD-7) directly to fCBT assessed six months after enrollment. S3. The studied stepped care model (sequential GSH followed by CBT for non-responders) is cost-saving in the long term compared to matched population controls, when direct and indirect health care, social care, employment, and societal costs are controlled. S4. Data collected by the Finnish Therapy Navigator, a digital tool to help assess individual needs and symptom profile for psychotherapy can be used to predict responses to treatment. S5. Longer waiting times for the study interventions are associated with poorer treatment response for those with baseline score of ≥10 on the GAD-7. S6. Patients seeking treatment with subclinical anxiety symptoms (baseline score of 5-9 on the GAD-7) benefit from psychotherapeutic interventions, in terms of reduced risk of developing clinical episodes and reduced total long-term societal costs. _____ Previous study objectives: Primary hypothesis P1. A stepped care model (sequential GSH followed by face-to-face cognitive behavioral therapy (CBT) for non-responders), and internet-delivered cognitive behavioral therapy (iCBT) are non-inferior (non-inferiority margin 1.7 points on the Generalized Anxiety Disorder scale, GAD-7) to CBT for treating clinical anxiety symptoms (baseline score of ≥10 on the GAD-7) at primary outcome measurement point (6 months after enrollment). Secondary hypotheses: S1. Effectiveness of stepped care (sequential GSH followed by CBT for non-responders) is better compared to directly admitting patients to CBT when treating clinical anxiety symptoms (baseline score of ≥10 on GAD-7), assessed at six months after enrollment. S2. The cost-effectiveness of stepped care (sequential GSH followed by CBT for non-responders) is better than directing all patients with anxiety symptoms directly to CBT or iCBT. S3. The studied stepped care model (sequential GSH followed by CBT for non-responders) is cost-saving in the long term compared to matched population controls, when direct and indirect health care, social care, employment, and societal costs are controlled. S4. Data collected by the Finnish Therapy Navigator, a digital tool to help assess individual needs and symptom profile for psychotherapy can be used to predict responses to treatment. S5. Longer waiting times for the study interventions are associated with poorer treatment response for those with baseline score of ≥10 on the GAD-7. S6. Patients seeking treatment with subclinical anxiety symptoms (baseline score of 5-9 on the GAD-7) benefit from psychotherapeutic interventions, in terms of reduced risk of developing clinical episodes and reduced total long-term societal costs. |
| Ethics approval(s) |
Approved 27/06/2024, Helsinki University Hospital (HUS) Regional Committee on Medical Research Ethics (PO BOX 705, 00029, Finland;, Helsinki, 00029, Finland; +358 9471 71607; eetinen.toimikunta@hus.fi), ref: HUS/6234/2023 |
| Health condition(s) or problem(s) studied | Treatment and prevention of anxiety symptoms in mental health services |
| Intervention | Participants will be randomized in the following three treatment arms (1:1:1) : 1. Stepped care model: guided self-help (GSH, average number of sessions 3) followed by face-to-face cognitive behavioral therapy (CBT, average number of sessions 7) for non-responders 2. Therapist guided internet delivered CBT (iCBT, 8 sessions) 3. Face-to-face cognitive behavioral therapy (CBT average number of sessions 7) We use stratified randomization to avoid potential biases in the data. The stratification will be done by symptom severity (5-9 p on the GAD-7; ≥10 p on the GAD-7) and by research location. The duration of treatments in the study arms are as follows: 1. Sequential treatment of guided self-help and face-to-face CBT (stepped care): approximately 3 months for anxiety 2. Face-to-face CBT: approximately 2 months for anxiety 3. Internet-delivered CBT: approximately 3 months for anxiety All study arms have a post-treatment measurement point (at the end of treatment). After that, the following follow-up points after randomization are same for all study arms: • Four months after randomization • Six months after randomization (primary outcome measurement point) • Eight months after randomization • Twelve months after randomization • Follows ups at two and five years |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Anxiety symptoms measured by the GAD-7. The GAD-7 is administered weekly from the beginning of the intervention for 16 weeks and at follow-up time points (e.g. 4, 6, 8, and 12 months as well as 2, 5, 10, 15 and 20 years) to enable ITT (intention to treat) -analysis and modeling the symptom change in time. |
| Key secondary outcome measure(s) |
1. Psychotropic medication use is measured using patient self-reports at baseline (T0), 4-month follow-up (T3), 6-month follow-up (T4), 8-month, 12-month, 2-year follow-ups, and optional 5, 10, 15, and 20-year follow-ups (T5). |
| Completion date | 31/12/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 948 |
| Key inclusion criteria | 1. Minimum age of 16 years 2. Suitable for step 1-2 treatments (guided self-help, iCBT or CBT intervention) for anxiety in the first assessment 3. GAD-7 ≥5 |
| Key exclusion criteria | General exclusion criteria for step 1-2 treatments (i.e. recommended stepping up): 1. Serious suicidal thoughts, plans or any self-harming act or suicidal attempt within the past 2 months 2. Ongoing other psychological treatment for depression and/or anxiety 3. Cognitive impairment 4. Inability to speak, read and write Finnish 5. Currently symptomatic psychotic illness or bipolar disorder 6. Drug or alcohol dependence |
| Date of first enrolment | 16/09/2024 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Finland
Study participating centres
00100
Finland
Finland
Finland
Finland
Finland
Finland
Finland
Finland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The data will be held by the Helsinki and Uusimaa Hospital District, and it will not be available because of limitations caused by the Finnish data protection legislation, content of consent requested, and research permit. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/07/2025: The following changes were made to the trial record:
1. The study objectives were changed.
2. The plain English summary was updated to reflect these changes.
13/09/2024: Trial's existence confirmed by Helsinki University Hospital (HUS) Regional Committee on Medical Research Ethics.
