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

Interventions

BEHAVIORAL

Brief interventions

'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.

BEHAVIORAL

Self-help CBT

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.

Sponsors & Collaborators

• The Kamprad Family Foundation for Entrepreneurship, Research & Charity

  collaborator OTHER

• Capio Group

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Linnaeus University

  lead OTHER

Principal Investigators

• Viktor Kaldo, Professor · Linnaeus University, Karolinska Institutet

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-14

Primary Completion

2025-12-31

Completion

2026-12-31

Countries

• Sweden

Study Locations