Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial

NCT04900064 | Recruiting

• 1 other identifier: 2020-04198-A2
• Study Type: interventional
• Target: 1,242
• Locations: 1 country
• Sites: 4

Brief 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 interventions. In addition to this, the study will investigate the overall effect of PCBH on both patient and organisation level outcomes.

Conditions

Panic Disorder; Social Anxiety Disorder; Depression; Hypochondriasis; Insomnia; Generalized Anxiety Disorder; Burnout; Adjustment Disorders; Stress, Psychological; Obsessive-Compulsive Disorder; Life Stress; Life Style Induced Illness; Psychological Distress

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Change during the period Pre, Week 4, Week 8, Week 12 and 1 year

• Patient Health Questionnaire 9-Item (PHQ-9)

  Change during the period Pre, Week 12 and 1 year

• Patient Health Questionnaire 2-Item (PHQ-9)

  Change during the period Pre, Week 4, Week 8, Week 12 and 1 year

• Generalized Anxiety Disorder 7-item (GAD-7)

  Change during the period Pre, Week 12 and 1 year

• Generalized Anxiety Disorder 2-item (GAD-2)

  Change during the period Pre, Week 4, Week 8, Week 12 and 1 year

Other Outcomes (18)

• Treatment Inventory of Costs in Psychiatric Patients (TIC-P)

  Pre, Week 12, 1 year

• Average waiting time

  At first visit

• Supply of bookable appointments

  Weekly from study start up to 2 years

Study Arms (4)

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.

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.

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.

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.

Behavioral: Brief interventions

Interventions

Brief interventions BEHAVIORAL

'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.

Also known as: Focused CBT, focused ACT, Focused Cognitive Behavioural Therapy, Focused Acceptance and Commitment Therapy

Contextual Assessment - All patients; Contextual Assessment - Suitable for self-help CBT but given brief interventions; Diagnostic Assessment - All patients

Self-help CBT BEHAVIORAL

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.

Also known as: Bibliotherapy, iCBT, Internet-Based Cognitive Behavioural Therapy, Blended Treatment, Self-help books

Diagnostic Assessment - All patients; Diagnostic Assessment - Given self-help CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Linnaeus University: lead
• The Kamprad Family Foundation for Entrepreneurship, Research & Charity: collaborator
• Capio Group: collaborator
• Karolinska Institutet: collaborator

Study Sites (4)

Vårdcentralen Västra Vall

Varberg, Halland County, Sweden

NOT YET RECRUITING

Capio Citykliniken Västra Hamnen

Malmo, Skåne County, Sweden

RECRUITING

Boo vårdcentral

Stockholm, Stockholm County, Sweden

NOT YET RECRUITING

Capio Vårdcentral Sävja

Uppsala, Uppsala County, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 40988013 DERIVED

MeSH Terms

Conditions

Panic Disorder; Phobia, Social; Depression; Hypochondriasis; Sleep Initiation and Maintenance Disorders; Generalized Anxiety Disorder; Burnout, Psychological; Adjustment Disorders; Stress, Psychological; Obsessive-Compulsive Disorder

Interventions

Crisis Intervention; Bibliotherapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Phobic Disorders; Behavioral Symptoms; Behavior; Somatoform Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Viktor Kaldo, Professor

  Linnaeus University, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anneli Farnsworth von Cederwald

CONTACT

+46722372300; anneli.farnsworthvoncederwald@lnu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will only be informed that they will be randomised between two different types of extended assessments, both of which are more extensive than regular healthcare. They will receive no information about the nature of the assessments or about different treatments following the assessments to avoid nocebo effects.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 25, 2021
• Study Start: June 14, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)