Panic DisorderKAIROSNCT04900064
Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial
A study testing Brief interventions and Self-help CBT in people with Panic Disorder and Social Anxiety Disorder, run by Linnaeus University at 4 sites in Sweden.
Trial summary
In this multicenter study, the investigators want to find out if an addition of an diagnostic assessment and possibility of treatment with guided self-help CBT can increase the treatment effects of PCBH on patient functioning and symptoms, compared to standard PCBH which uses contextual assessment and brief… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Panic Disorder, Social Anxiety Disorder, Depression
- What is being tested?
- Brief interventions and Self-help CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,242 participants
- Where
- 4 sitesSweden
- Study dates
- 14 Jun 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All patients from age 18 who seek care at the PCC, who are deemed to be suitable for Behavioural Health interventions and booked to the mental health professionals at the PCC, according to screening methods and/or clinical assessments made by health care personnel at the PCC, will be included. This broad criteria reflects the naturalistic setting where decisions of clinicians, rather than highly standardized criteria, are the basis for inclusion.
Who cannot join
- Does not speak Swedish well enough to fill out questionnaires or to receive self-help CBT in Swedish.
- Is in need of emergency type care, like with suicidal ideation or behaviours, ongoing psychosis or mania.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden4 sites, 4 recruiting
- Recruiting
Capio Citykliniken Västra Hamnen
Malmö, Skåne County
Marit Bengtson, marit.bengtson@capio.se
- Not yet recruiting
Boo vårdcentral
Stockholm, Stockholm County
Katrin Hagskog Engel, katrin.hagskog-engel@sll.se
- Recruiting
Capio Vårdcentral Sävja
Uppsala, Uppsala County
Linnea Fällström, linnea.fallstrom@capio.se
- Not yet recruiting
Vårdcentralen Västra Vall
Varberg, Halland County
Filip Axell, filip.axell@regionhalland.se
About this study
Official title: Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial for Superiority and Non-superiority Comparisons of Effects on Patients' Everyday Function, Symptoms, and Experiences
In this multicenter study, the investigators want to find out if an addition of an diagnostic assessment and possibility of treatment with guided self-help CBT can increase the treatment effects of PCBH on patient functioning and symptoms, compared to standard PCBH which uses contextual assessment and brief interventions. In addition to this, the study will investigate the overall effect of PCBH on both patient and organisation level outcomes.
Read the detailed description
The overarching goal of primary care is to offer all patients individualised and context-sensitive healthcare with high access and continuity. One of the reasons primary care struggles with this goal is that a large proportion of patients suffer from mental and behavioural health problems, alone or in combination with one or several chronic illnesses. Despite many patients needing psychosocial interventions, there is a lack of mental health professionals as well as clear pathways for these patients.
Primary Care Behavioural Health (PCBH) is an innovative way of organising primary care, where mental health professionals have more yet shorter visits, strive for same-day access, and have an active consulting role in the primary care team. To help patients achieve relevant behavioural changes, so called brief interventions are used, which are based on isolated components from psychological treatments such as Cognitive Behavioural Therapy (CBT) and Acceptance and Commitment Therapy (ACT). Brief interventions usually stretch over 1-4 treatment sessions. Assessments within the model are generally contextual and largely avoid psychiatric diagnostics, instead focussing on the patient's situation and their associated coping strategies - whether they be positive or negative. However, these interventions have not been systematically evaluated in the same way that structured CBT has, and there is a risk that patients that would have benefitted from structured CBT and a diagnostic assessment are undertreated due to lack of diagnostics and the reduced visit duration and amount.
Data will be collected at primary care centres (PCCs) that already have a high fidelity to a PCBH framework. Fidelity will be measured by an expert group as well as using four questionnaires, one for each of mental health professionals, medical doctors, registered nurses and leadership. These fidelity scales will be validated in a separate study. In addition to fidelity, work environment and satisfaction with the PCBH implementation will be measured.
Patients at the centres will be randomised between receiving contextual assessments followed by brief interventions, or a diagnostic assessment, which can lead to treatment with either self-help CBT (if a treatable diagnosis is confirmed and the patient is suitable for self-help CBT) or brief interventions (if self-help CBT is not deemed to be a suitable intervention). The primary comparison is the outcome for patients who either received self-help CBT or are deemed suitable for the intervention based on screening data, while secondary analyses will look at treatment outcomes for all patients, including those with non-psychiatric problems such as crises, loss or work- or family-related problems. The study will also look at implementation outcomes for self-help CBT and diagnostic assessments to see if self-help CBT is a feasible addition to the PCBH model. Our main research questions are:
- Does an extended version of PCBH, including an additional assessment and the option of guided self-help CBT when indicated by a patient's problem profile, lead to superior patient outcomes compared to standard PCBH where a brief, contextual assessment followed by Brief Interventions is the only option? If not, can standard PCBH be shown to be non-inferior?
- Does the addition of guided self-help CBT have a negative effect on availability, reach, and cost-effectiveness compared to standard PCBH? If not, can guided self-help CBT be shown to be non-inferior to standard PCBH concerning these outcomes?
PCBH has the potential to increase the quality and access of care for many patients with mental and behavioural health problems. This study is the first to step towards answering whether or not the effects of brief intervention are large enough to merit large-scale implementation, and if an add-on of other brief and easily implementable treatments can increase the treatment effects.
- Conditions
- Panic Disorder, Social Anxiety Disorder, Depression, Hypochondriasis, Insomnia, Generalized Anxiety Disorder
- Being tested
- Brief interventions, Self-help CBT
- Medical subject headings
- Panic Disorder, Phobia, Social, Depression, Hypochondriasis, Sleep Initiation and Maintenance Disorders, Generalized Anxiety Disorder, Burnout, Psychological, Adjustment Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief interventionsBehavioural
Also called Focused CBT, focused ACT, Focused Cognitive Behavioural Therapy, Focused Acceptance and Commitment Therapy
'Brief Interventions' (BI) is a generic term for a multitude of tools and interventions used in patient visits within PCBH. BI start immediately at the initial consultation, which ends with a personally tailored and evidence-informed plan adjusted to the patient's context. As such, there is no separation between assessment and intervention. The interventions within BI often have their foundation in CBT, ACT or Motivational Interviewing (MI). The common theme is that they are principle-based rather than manual-based and focus on behavioural change in relation to a problem, rather than focusing on a specific diagnosis. Follow-up appointments are scheduled flexibly depending on the patient's perceived need. A BI treatment usually consists of 1-4 appointments with several weeks apart and has an open ending, where the patient easily can schedule a new appointment. Clinicians delivering brief interventions will have had 3 days of training as well as regular supervision.
Self-help CBTBehavioural
Also called Bibliotherapy, iCBT, Internet-Based Cognitive Behavioural Therapy, Blended Treatment, Self-help books
The patient receives a previously scientifically evaluated CBT-based self-help book for one of the following conditions: depression, generalized anxiety disorder, panic disorder, social anxiety, health anxiety, insomnia, or stress/burnout. The therapist support consists of 3-6 contacts throughout the 6-12 weeks long intervention period as decided by the clinician and patient together, as long as at least one and not more than three are physical visits at the center and the rest via phone, video conferencing, or secure internet messages. Clinicians delivering self-help CBT will need four days of reading and two days of training as well as regular supervision to be able to make initial assessments and problem profiling and use the self-help books.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Assessment - Given self-help CBT | Experimental | The diagnostic assessment includes screening instruments, a structured interpretation of the screening instruments, a structured interview (MINI - International Neuropsychiatric Interview) and a medical anamnesis. If deemed appropriate, the patient can be offered treatment with guided self help. If the patient's problem is not deemed appropriate for this type of care or if the patient is not interested in guided self-help, they are offered brief interventions (BI).
In the primary analysis, only patients receiving treatment with self-help CBT are included. Receives: Behavioral: Self-help CBT |
| Contextual Assessment - Suitable for self-help CBT but given brief interventions | Active comparator | The contextual assessment includes screening instruments and a contextual interview. Patients in this arm will always be treated with brief interventions.
In the primary analysis, only patients suitable for self-help CBT are included. This is decided by an algorithm based on data from their screening, which takes into account symptom severity and type, patient preference and known variables that make self-help CBT a worse fit. Receives: Behavioral: Brief interventions |
| Diagnostic Assessment - All patients | Experimental | Same as the other arm marked as "Experimental", but for the purpose of a secondary analysis all patients randomised to Diagnostic Assessment are included, regardless if they receive treatment with self-help CBT or brief interventions. Receives: Behavioral: Brief interventions; Behavioral: Self-help CBT |
| Contextual Assessment - All patients | Active comparator | Same as the other arm marked as "Experimental", but for the purpose of a secondary analysis all patients randomised to Diagnostic Assessment are included, regardless if they are deemed suitable for self-help CBT or not. Receives: Behavioral: Brief interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (4 domains)
The four domains of Life activities, Cognition, Getting along, and Participation. In the 12-item version of the WHO Disability Assessment Schedule 2.0 (WHODAS-12) will be used as primary outcome, since these are condition-independent measures of Behavioral Health relevant everyday functioning. The scale ranges from 0 to 32 points. A lower score means better functioning. As such, a lower score is a better outcome.
Measured: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Secondary outcomes (26)
WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (whole instrument)
The two domains of Mobility and Self-care will be measured and the whole WHODAS will be used in some secondary analyses, but not for the primary outcome since these domains tend to form two independent factors, many patients will have initial adequate function in these domains and they are not expected to change much. The scale ranges from 0 to 48 points. A lower score means better functioning. As such, a lower score is a better outcome.
Measured: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Patient Health Questionnaire 9-Item (PHQ-9)
The full version of a well-validated scale for measuring depressive symptoms. PHQ-9 total score for the nine items ranges from 0 to 27. A lower score means less depressive symptoms. As such, a lower score is a better outcome.
Measured: Change during the period Pre, Week 12 and 1 year
Patient Health Questionnaire 2-Item (PHQ-9)
PHQ-2 consists of two questions from the PHQ-9. This will be administered as part of the PHQ-9 on the above mentioned time points, and will replace the PHQ-9 on the mid-treatment measurements. The scale ranges from 0 to 6 points. A lower score means less depressive symptoms. As such, a lower score is a better outcome.
Measured: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Generalized Anxiety Disorder 7-item (GAD-7)
The full version of a well-validated scale for measuring anxiety symptoms. GAD-7 total score for the seven items ranges from 0 to 21. A lower score means less anxiety symptoms. As such, a lower score is a better outcome.
Measured: Change during the period Pre, Week 12 and 1 year
Generalized Anxiety Disorder 2-item (GAD-2)
GAD-2 consists of two questions from the GAD-7. This will be administered as part of the GAD-7 on the above mentioned time points, and will replace the GAD-7 on the mid-treatment measurements. The scale ranges from 0 to 6 points. A lower score means less anxiety symptoms. As such, a lower score is a better outcome.
Measured: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Social Phobia Inventory - Abbreviated version (Mini-SPIN)
Social anxiety symptoms are measured with a very short version of a well established patient-rated scale for social phobia. The scale ranges from 0 to 12 points. A lower score means less symptoms of social anxiety. As such, a lower score is a better outcome.
Measured: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
The Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
Symptoms of alcohol misuse are measured with a very short version of a well established patient-rated scale for alcohol misuse. The scale ranges from 0 to 12 points. A lower score means less symptoms of alcohol misuse. As such, a lower score is a better outcome.
Measured: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Panic Disorder Severity Scale - Self rated 2-item (PDSS-SR-MINI-2)
Symptoms of panic attacks are measured by a very short version of a well established patient-rated scale and has been created by factor analytic item-reduction and sensitivity to change analyses from large datasets from previous trial within the research group. The scale ranges from 0 to 8 points. A lower score means less symptoms of panic disorder. As such, a lower score is a better outcome.
Measured: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Karolinska Exhaustion Disorder Scale 3-item (KEDS-3) + 2 confirming questions from s-UMS
Symptoms of stress-related exhaustion are measured with a very short version of a well established patient-rated scale and has been created by an expert group, who chose three representative questions from the original KEDS scale. To aid with diagnostics, two confirmatory questions from the Swedish s-UMS scale were added, asking for duration and presumed cause of symptoms. The scale ranges from 0 to 18 points. A lower score means less symptoms of stress-related exhaustion. As such, a lower score is a better outcome.
Measured: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Perceived Stress Scale (PSS-MINI-2) + 2 new questions
Stress symptoms are measured by a very short version of a well established patient-rated scale and has been created by factor analytic item-reduction and sensitivity to change analyses from large datasets from previous trial within the research group. To increase face validity of the very short scale, we also added two more direct questions ("Have you been feeling stressed lately?", "Have you been feeling tense lately?"). The scale ranges from 0 to 16 points. A lower score means less stress symptoms. As such, a lower score is a better outcome.
Measured: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Insomnia Severity Index 2-item (ISI-MINI-2)
Symptoms of sleep disorders are measured by a very short version of a well established patient-rated scale and has been created by factor analytic item-reduction and sensitivity to change analyses from large datasets from previous trial within the research group. The scale ranges from 0 to 8 points. A lower score means less sleep problems. As such, a lower score is a better outcome.
Measured: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Short Health Anxiety Inventory 3-item (SHAI-MINI-3)
Symptoms of health anxiety are measured by a very short version of a well established patient-rated scale and has been created by factor analytic item-reduction and sensitivity to change analyses from large datasets from previous trial within the research group. The scale ranges from 0 to 9 points. A lower score means less symptoms of health anxiety. As such, a lower score is a better outcome.
Measured: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Obsessive Compulsive Disorder 3-Item (OCD-3-MINI)
Symptoms of obsessive compulsive disorder are measured by a very short patient-rated scale and has been created by an expert group. The scale ranges from 0 to 12 points. A lower score means less obsessive/compulsive thoughts and behaviors. As such, a lower score is a better outcome.
Measured: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Pain One-item Rating
Pain is measured on a scale from 0 to 10, where 0 is no pain and 10 is worst pain imaginable. As such, a lower score is a better outcome.
Measured: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Total symptom index
Also, a total index for level of symptoms will be calculated from all symptom items, where different weights will be used to balance the different number of questions for different domains, for example to avoid the larger number of items related to anxiety to overshadow depression ratings. The scale ranges from 0 to 20 points. A lower score means less mental health symptoms overall. As such, a lower score is a better outcome.
Measured: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Brunnsviken Brief Quality of Life Questionnaire (BBQ)
Quality of life will be measure be the 12-item Brunnsviken Brief Quality of life (BBQ-12), asking about importance and fulfilment of six areas (e.g. spare time quality, creative work, and friendship). The scale ranges from 0 to 96 points. A lower score means lower quality of life. As such, a higher score is a better outcome.
Measured: Change during the period Pre, Week 12 and 1 year
Outcome Rating Scale (ORS)
The ORS is a four-item measure designed to assess areas of life functioning known to change as a result of therapeutic intervention. These include symptom distress, interpersonal well-being, social role, and overall well-being, measured by four visual analogue scales. The scale ranges from 0 to 40 points. A lower score means lower satisfaction with life areas. As such, a higher score is a better outcome.
Measured: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Session Rating Scale (SRS)
The Session Rating Scale (SRS) is a four-item visual analogue scale designed to assess key dimensions of effective therapeutic relationships. These include respect and understanding, relevance of the goals and topics, client-practitioner fit and overall alliance. The scale ranges from 0 to 40 points. A lower score means lower ratings of the therapeutic alliance. As such, a higher score is a better outcome.
Measured: Week 4, Week 8, Week 12 and 1 year
One item Clinical Global Impression - Improvement (CGI-I)
Related to main problem seeking care for as rated by clinician. The scale ranges from 0 to 7 points. A lower score means a larger improvement for the patient. As such, a lower score is a better outcome.
Measured: After every session during week 1-12
Patient-rated perception and attitude toward care provider
9-items previously used in PCBH-settings (self-report), and four items from the Client Satisfaction Questionnaire (CSQ). The scale ranges from 0 to 57 points. A lower score means less satisfaction with care. As such, a higher score is a better outcome.
Measured: Week 12
Description of Behavioral Health Plan (PCBH) or main treatment goal and methods (shCBT) as structured note by clinician in medical record
Interview form.
Measured: Week 12
Patient recollection of plan/goal/methods, descriptions of behaviour changes made
Interview form.
Measured: Week 12
Experienced negative/Adverse Events, where the worst and most probably care-induced event is more thoroughly described and rated on severity and perceived cause
Interview form.
Measured: Week 12
Adverse Events-9
9 items asking patients to detail any adverse events that occurred as a result of treatment.
Measured: Week 12
Adverse Events-3
3 items asking patients to detail any adverse events that occurred as a result of treatment.
Measured: Week 4, Week 8
Well-being Behaviours-11
11 items asking patients how often they engage in behaviours related to maintaining physical and mental well-being, such as physical exercise and having adequate sleep hygiene.
Measured: Change during the period Pre, Week 12 and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start14 Jun 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Patients are randomised between a diagnostic assessment and a contextual assessment. Patients in the contextual assessment arm can only be treated with brief interventions whereas patients in the diagnostic assessment arm are offered guided self-help if deemed appropriate and otherwise gets brief interventions. As such, patients are randomised between two arms. We have however included four arms below in order to be able to describe the primary and secondary analysis. The primary analysis is performed on all patients treated with self-help CBT in the arm where a diagnostic assessment is made, compared to patients in the contextual assessment arm that are found suitable for self-help CBT (based on screening data), but treated with brief interventions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linnaeus University
- Sponsor type
- University, hospital or other
- Collaborators
- The Kamprad Family Foundation for Entrepreneurship, Research & Charity, Capio Group, Karolinska Institutet
- Responsible party
- Principal investigator, Viktor Kaldo, Linnaeus University
- Investigators
- Viktor Kaldo, Professor, Principal investigator, Linnaeus University, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900064
- Sponsor's protocol ID
- 2020-04198-A2
- Acronym
- KAIROS
- Status last verified
- Apr 2025
- First submitted
- 12 May 2021
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farnsworth von Cederwald A, Salomonsson S, Hentati Isacsson N, Kaldo V. Evaluation of Primary Care Behavioral Health (PCBH) with guided self-help CBT as a treatment option - a protocol of a single-blind randomized multicenter trial (KAIROS). BMC Health Serv Res. 2025 Sep 23;25(1):1208. doi: 10.1186/s12913-025-13232-4.
PubMed 40988013
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial for Superiority and Non-superiority Comparisons of Effects on Patients' Everyday Function, Symptoms, and Experiences
- ClinicalTrials.gov ID
- NCT04900064
- Acronym / sponsor ID
- KAIROS / 2020-04198-A2
- Conditions
- Panic Disorder, Social Anxiety Disorder, Depression, Hypochondriasis, Insomnia, Generalized Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,242 participants (estimated)
- Lead sponsor
- Linnaeus UniversityUniversity, hospital or other
- Collaborators
- The Kamprad Family Foundation for Entrepreneurship, Research & Charity, Capio Group, Karolinska Institutet
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this multicenter study, the investigators want to find out if an addition of an diagnostic assessment and possibility of treatment with guided self-help CBT can increase the treatment effects of PCBH on patient functioning and symptoms, compared to standard PCBH which uses contextual assessment and brief interventions. In addition to this, the study will investigate the overall effect of PCBH on both patient and organisation level outcomes.
Detailed description
The overarching goal of primary care is to offer all patients individualised and context-sensitive healthcare with high access and continuity. One of the reasons primary care struggles with this goal is that a large proportion of patients suffer from mental and behavioural health problems, alone or in combination with one or several chronic illnesses. Despite many patients needing psychosocial interventions, there is a lack of mental health professionals as well as clear pathways for these patients.
Primary Care Behavioural Health (PCBH) is an innovative way of organising primary care, where mental health professionals have more yet shorter visits, strive for same-day access, and have an active consulting role in the primary care team. To help patients achieve relevant behavioural changes, so called brief interventions are used, which are based on isolated components from psychological treatments such as Cognitive Behavioural Therapy (CBT) and Acceptance and Commitment Therapy (ACT). Brief interventions usually stretch over 1-4 treatment sessions. Assessments within the model are generally contextual and largely avoid psychiatric diagnostics, instead focussing on the patient's situation and their associated coping strategies - whether they be positive or negative. However, these interventions have not been systematically evaluated in the same way that structured CBT has, and there is a risk that patients that would have benefitted from structured CBT and a diagnostic assessment are undertreated due to lack of diagnostics and the reduced visit duration and amount.
Data will be collected at primary care centres (PCCs) that already have a high fidelity to a PCBH framework. Fidelity will be measured by an expert group as well as using four questionnaires, one for each of mental health professionals, medical doctors, registered nurses and leadership. These fidelity scales will be validated in a separate study. In addition to fidelity, work environment and satisfaction with the PCBH implementation will be measured.
Patients at the centres will be randomised between receiving contextual assessments followed by brief interventions, or a diagnostic assessment, which can lead to treatment with either self-help CBT (if a treatable diagnosis is confirmed and the patient is suitable for self-help CBT) or brief interventions (if self-help CBT is not deemed to be a suitable intervention). The primary comparison is the outcome for patients who either received self-help CBT or are deemed suitable for the intervention based on screening data, while secondary analyses will look at treatment outcomes for all patients, including those with non-psychiatric problems such as crises, loss or work- or family-related problems. The study will also look at implementation outcomes for self-help CBT and diagnostic assessments to see if self-help CBT is a feasible addition to the PCBH model. Our main research questions are:
- Does an extended version of PCBH, including an additional assessment and the option of guided self-help CBT when indicated by a patient's problem profile, lead to superior patient outcomes compared to standard PCBH where a brief, contextual assessment followed by Brief Interventions is the only option? If not, can standard PCBH be shown to be non-inferior?
- Does the addition of guided self-help CBT have a negative effect on availability, reach, and cost-effectiveness compared to standard PCBH? If not, can guided self-help CBT be shown to be non-inferior to standard PCBH concerning these outcomes?
PCBH has the potential to increase the quality and access of care for many patients with mental and behavioural health problems. This study is the first to step towards answering whether or not the effects of brief intervention are large enough to merit large-scale implementation, and if an add-on of other brief and easily implementable treatments can increase the treatment effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Patients are randomised between a diagnostic assessment and a contextual assessment. Patients in the contextual assessment arm can only be treated with brief interventions whereas patients in the diagnostic assessment arm are offered guided self-help if deemed appropriate and otherwise gets brief interventions. As such, patients are randomised between two arms. We have however included four arms below in order to be able to describe the primary and secondary analysis. The primary analysis is performed on all patients treated with self-help CBT in the arm where a diagnostic assessment is made, compared to patients in the contextual assessment arm that are found suitable for self-help CBT (based on screening data), but treated with brief interventions.
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Assessment - Given self-help CBT | Experimental | Behavioral: Self-help CBTThe diagnostic assessment includes screening instruments, a structured interpretation of the screening instruments, a structured interview (MINI - International Neuropsychiatric Interview) and a medical anamnesis. If deemed appropriate, the patient can be offered treatment with guided self help. If the patient's problem is not deemed appropriate for this type of care or if the patient is not interested in guided self-help, they are offered brief interventions (BI). In the primary analysis, only patients receiving treatment with self-help CBT are included. |
| Contextual Assessment - Suitable for self-help CBT but given brief interventions | Active comparator | Behavioral: Brief interventionsThe contextual assessment includes screening instruments and a contextual interview. Patients in this arm will always be treated with brief interventions. In the primary analysis, only patients suitable for self-help CBT are included. This is decided by an algorithm based on data from their screening, which takes into account symptom severity and type, patient preference and known variables that make self-help CBT a worse fit. |
| Diagnostic Assessment - All patients | Experimental | Behavioral: Brief interventions, Behavioral: Self-help CBTSame as the other arm marked as "Experimental", but for the purpose of a secondary analysis all patients randomised to Diagnostic Assessment are included, regardless if they receive treatment with self-help CBT or brief interventions. |
| Contextual Assessment - All patients | Active comparator | Behavioral: Brief interventionsSame as the other arm marked as "Experimental", but for the purpose of a secondary analysis all patients randomised to Diagnostic Assessment are included, regardless if they are deemed suitable for self-help CBT or not. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients from age 18 who seek care at the PCC, who are deemed to be suitable for Behavioural Health interventions and booked to the mental health professionals at the PCC, according to screening methods and/or clinical assessments made by health care personnel at the PCC, will be included. This broad criteria reflects the naturalistic setting where decisions of clinicians, rather than highly standardized criteria, are the basis for inclusion.
Key exclusion criteria (2 listed)
- Does not speak Swedish well enough to fill out questionnaires or to receive self-help CBT in Swedish.
- Is in need of emergency type care, like with suicidal ideation or behaviours, ongoing psychosis or mania.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief interventionsAlso: Focused CBT, focused ACT, Focused Cognitive Behavioural Therapy, Focused Acceptance and Commitment Therapy'Brief Interventions' (BI) is a generic term for a multitude of tools and interventions used in patient visits within PCBH. BI start immediately at the initial consultation, which ends with a personally tailored and evidence-informed plan adjusted to the patient's context. As such, there is no separation between assessment and intervention. The interventions within BI often have their foundation in CBT, ACT or Motivational Interviewing (MI). The common theme is that they are principle-based rather than manual-based and focus on behavioural change in relation to a problem, rather than focusing on a specific diagnosis. Follow-up appointments are scheduled flexibly depending on the patient's perceived need. A BI treatment usually consists of 1-4 appointments with several weeks apart and has an open ending, where the patient easily can schedule a new appointment. Clinicians delivering brief interventions will have had 3 days of training as well as regular supervision. | Behavioural | Contextual Assessment - All patients, Contextual Assessment - Suitable for self-help CBT but given brief interventions, Diagnostic Assessment - All patients |
| Self-help CBTAlso: Bibliotherapy, iCBT, Internet-Based Cognitive Behavioural Therapy, Blended Treatment, Self-help booksThe patient receives a previously scientifically evaluated CBT-based self-help book for one of the following conditions: depression, generalized anxiety disorder, panic disorder, social anxiety, health anxiety, insomnia, or stress/burnout. The therapist support consists of 3-6 contacts throughout the 6-12 weeks long intervention period as decided by the clinician and patient together, as long as at least one and not more than three are physical visits at the center and the rest via phone, video conferencing, or secure internet messages. Clinicians delivering self-help CBT will need four days of reading and two days of training as well as regular supervision to be able to make initial assessments and problem profiling and use the self-help books. | Behavioural | Diagnostic Assessment - All patients, Diagnostic Assessment - Given self-help CBT |
Primary outcome
WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (4 domains)
Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
The four domains of Life activities, Cognition, Getting along, and Participation. In the 12-item version of the WHO Disability Assessment Schedule 2.0 (WHODAS-12) will be used as primary outcome, since these are condition-independent measures of Behavioral Health relevant everyday functioning. The scale ranges from 0 to 32 points. A lower score means better functioning. As such, a lower score is a better outcome.
26 secondary outcomes
WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (whole instrument)
Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Patient Health Questionnaire 9-Item (PHQ-9)
Time frame: Change during the period Pre, Week 12 and 1 year
Patient Health Questionnaire 2-Item (PHQ-9)
Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: Change during the period Pre, Week 12 and 1 year
Generalized Anxiety Disorder 2-item (GAD-2)
Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Social Phobia Inventory - Abbreviated version (Mini-SPIN)
Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
The Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Panic Disorder Severity Scale - Self rated 2-item (PDSS-SR-MINI-2)
Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Karolinska Exhaustion Disorder Scale 3-item (KEDS-3) + 2 confirming questions from s-UMS
Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Perceived Stress Scale (PSS-MINI-2) + 2 new questions
Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Insomnia Severity Index 2-item (ISI-MINI-2)
Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Short Health Anxiety Inventory 3-item (SHAI-MINI-3)
Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Obsessive Compulsive Disorder 3-Item (OCD-3-MINI)
Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Pain One-item Rating
Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Total symptom index
Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Brunnsviken Brief Quality of Life Questionnaire (BBQ)
Time frame: Change during the period Pre, Week 12 and 1 year
Outcome Rating Scale (ORS)
Time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
Session Rating Scale (SRS)
Time frame: Week 4, Week 8, Week 12 and 1 year
One item Clinical Global Impression - Improvement (CGI-I)
Time frame: After every session during week 1-12
Patient-rated perception and attitude toward care provider
Time frame: Week 12
Description of Behavioral Health Plan (PCBH) or main treatment goal and methods (shCBT) as structured note by clinician in medical record
Time frame: Week 12
Patient recollection of plan/goal/methods, descriptions of behaviour changes made
Time frame: Week 12
Experienced negative/Adverse Events, where the worst and most probably care-induced event is more thoroughly described and rated on severity and perceived cause
Time frame: Week 12
Adverse Events-9
Time frame: Week 12
Adverse Events-3
Time frame: Week 4, Week 8
Well-being Behaviours-11
Time frame: Change during the period Pre, Week 12 and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Derived from this study: PubMed 40988013Farnsworth von Cederwald A, Salomonsson S, Hentati Isacsson N, Kaldo V. Evaluation of Primary Care Behavioral Health (PCBH) with guided self-help CBT as a treatment option - a protocol of a single-blind randomized multicenter trial (KAIROS). BMC Health Serv Res. 2025 Sep 23;25(1):1208. doi: 10.1186/s12913-025-13232-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Viktor Kaldo, Professor principal investigator
Linnaeus University, Karolinska Institutet
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief interventions and Self-help CBT in people with Panic Disorder and Social Anxiety Disorder, run by Linnaeus University at 4 sites in Sweden.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anneli Farnsworth von Cederwald (+46722372300, anneli.farnsworthvoncederwald@lnu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (4 domains) (time frame: Change during the period Pre, Week 4, Week 8, Week 12 and 1 year). 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 NCT04900064, which also lists 1 linked publication.
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 11 Apr 2025.