PCBH With the Addition of Self-help CBT

NCT04411771 | Completed

• 1 other identifier: 2019-00699
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 2

Brief Summary

The overarching goal of primary care is to offer all patients individualized and context-sensitive healthcare with high access and continuity. One of the reasons primary care struggles with this goal is that many patients suffer from mental health problems, while there is a lack of psychosocial resources as well as clear pathways for these patients. Primary care behavioural health (PCBH, in Swedish IBH) is an innovative way of organizing primary care, where psychosocial resources have more and shorter visits, strive for same-day access, and have an active consulting role in the primary care team. To help patients with achieving relevant behavior changes, so called Brief Interventions are used. However, these interventions have not been systematically evaluated in the same way that CBT has, and there is a risk that patients that would have benefitted from structured CBT are undertreated. This study is a pilot study preparing for a large multicenter study that will be conducted starting in late 2020. The investigators want to find out if an addition of an extended evaluation and possibility of treatment with guided CBT self-help can increase the treatment effects of PCBH on patient functioning and symptoms, compared to standard PCBH with a contextual assessment and brief interventions. In the process, the investigators are also conducting one of the first RCT on brief interventions. As this is a pilot study, the feasibility of implementing the study protocol in regular healthcare is also tested in order to collect high-quality data while creating minimal disturbance in the centers' ordinary routines. PCBH has the potential to increase the quality of care for patients with mental health problems. This study is the first to step towards answering the question if the effects of brief intervention are large enough to merit large-scale implementation, and if an add-on of other brief and easily implemented treatments can increase them.

Conditions

Depression, Anxiety; Quality of Life; Psychological Distress; Activities, Daily Living; Insomnia; Stress

Keywords

PCBH; Primary Care Behavioral Health; Integrated Behavioural Health; Primary Care Mental Health Services; Primary Care; Brief Interventions; Focused Acceptance and Commitment Therapy; Brief CBT; IBH; CBT; Self-help; Guided Self-help

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-Week4-Week8

Secondary Outcomes (20)

• WHO Disability Assessment Schedule 2.0 12-item (WHODAS-12) (whole instrument)

  Change during the period Pre-Week4-Week8-Week 52

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

  Change during the period Pre-Week4-Week8-Week 52

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

  Change during the period Pre-Week4-Week8-Week 52

• Social Phobia Inventory - Abbreviated version (Mini-SPIN)

  Change during the period Pre-Week4-Week8-Week 52

• The Alcohol Use Disorders Identification Test-Concise (AUDIT-C)

  Change during the period Pre-Week4-Week8-Week 52

Study Arms (4)

Extended Assessment - Given shCBT

EXPERIMENTAL

The extended assessment includes screening instruments, a structured interpretation of the screening instruments, a structured 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 given shCBT are included

Behavioral: Guided self-help CBT

Screening Assessment - Suitable for shCBT but given BI

ACTIVE COMPARATOR

The screening assessment includes screening instruments and a contextual interview. Patients in this arm will always be treated with brief interventions. In the primary anaysis, only patients suited for shCBT are included, as decided from an algorithm based on data from their screening.

Behavioral: Brief interventions

Extended Assessment - All patients

EXPERIMENTAL

Same as the other arm marked as "Experimental", but for the purpose of a secondary analysis all patients randomized to Extended Assessment are included, regardless of if they start shCBT or BI

Behavioral: Brief interventions; Behavioral: Guided self-help CBT

Screening Assessment - All patients

ACTIVE COMPARATOR

Same as the other arm marked as "Active comparator", but for the purpose of a secondary analysis all patients randomized to Screening Assessment are included, regardless of if they are suiteble for shCBT 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 MI. The common theme is that they are principle-based rather than manual-based and focus on behavioral change in relation to a problem that is perceived both possible to affect and relevant to the patient, rather than focusing on a specific diagnosis or condition. Follow-up appointments are scheduled flexibly depending on the patient's perceived need. Usually a BI treatment consists of 1-4 appointments with several weeks apart and ends when the patient feels that they are moving in the right direction.

Also known as: Focused interventions, brief CBT, focused Acceptance and Commitment Therapy, FACT, focused ACT

Extended Assessment - All patients; Screening Assessment - All patients; Screening Assessment - Suitable for shCBT but given BI

Guided 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 shCBT will need four days of reading and two days of training to be able to make initial assessments and problem profiling and use the self-help books.

Also known as: Self-help books, bibliotherapy, self-help CBT

Extended Assessment - All patients; Extended Assessment - Given shCBT

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.
• Is in need of emergency type care, like with suicidal ideation or behaviours, ongoing psychosis or mania.

Sponsors & Collaborators

• Linnaeus University: lead
• Kronoberg County Council: collaborator
• Capio Group: collaborator

Study Sites (2)

Vårdcentralen Centrum

Vaxjo, Kronoberg County, 35231, Sweden

Location

Capio Citykliniken Västra Hamnen

Malmo, Skåne County, 21119, Sweden

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Motor Activity; Sleep Initiation and Maintenance Disorders

Interventions

Crisis Intervention; Bibliotherapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Viktor Kaldo, Professor

  Linnaeus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be informed only 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 extended 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 an extended assessment and a screening assessment. Patients in the screening assessment arm can only be treated with brief interventions whereas patients in the extended assessment arm are offered guided self-help if deemed appropriate and otherwise gets brief interventions. Patients are thus randomized to two arms, however we have included four arms in order to be able to describe the primary and secondary analysis. The primary is performed on all patients treated with shCBT in the arm where an extended assessment is made, compared to patients in the screening assessment arm that is found suitable for shCBT (base on screening data), but treated with brief interventions.

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: June 2, 2020
• Study Start: February 4, 2019
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)