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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLinnaeus University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

1,242 Participants
are divided into 4 treatment groups
Group A: Diagnostic Assessment - Given self-help CBTExperimental treatment 1 intervention
Group B: Contextual Assessment - Suitable for self-help CBT but given brief interventionsActive comparator 1 intervention
Group C: Diagnostic Assessment - All patientsExperimental treatment 2 interventions
Group D: Contextual Assessment - All patientsActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
Change during the period Pre, Week 4, Week 8, Week 12 and 1 year
2

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.

Time frame
Change during the period Pre, Week 12 and 1 year
3

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.

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

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.

Time frame
Change during the period Pre, Week 12 and 1 year

Other outcomes

1

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

The TIC-P is a validated patient-reported outcome measure concerning the utilization of medical care and productivity losses. It does not have a minimum or maximum score but collects information that is needed for doing health economic calculations. This includes outcome measures such as amount of days on sick leave, productivity loss when at work, productivity loss at home, and medications prescribed and taken. Patient self-report will be complemented with register-level data on sick leave and medications.

Time frame
Pre, Week 12, 1 year
2

Average waiting time

\- Average waiting time from the identification of a behavioural health concern to being seen by any clinician among patients in the study

Time frame
At first visit
3

Supply of bookable appointments

Amount of bookable times per week and full time psychosocial resources (personnel in training counted as 75% of full time), an indirect measure of availability to psychosocial resources

Time frame
Weekly from study start up to 2 years
4

Third next available appointment (TNAA)

Waiting time until next available appointment for a third hypothetical patient that calls in on a given day for every clinician at the PCC, measured on the same time every week (e. g. Mondays at 9 AM), a measure of access to and and availability of care

Time frame
Weekly from study start up to 2 years

Sponsors and contacts

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Linnaeus University

Lead sponsor

The Kamprad Family Foundation for Entrepreneurship, Research & Charity

Collaborator

Capio Group

Collaborator

Karolinska Institutet

Collaborator