A Transdiagnostic Course for Common Mental Health Problems in Primary Care

NCT ID: NCT04522713

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-12-03

Brief Summary

This study investigates the feasibility of a transdiagnostic course that is intended to work for a large variety of patient groups with clinically significant depression or anxiety in primary care. This is a prospective single-group study where 68 adults with clinically significant symptoms of depression or general anxiety, and up to 25 adults with subclinical symptoms, attend up to 6 weekly structured large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing. If necessary, due to the covid-19 pandemic, the course will be held online.

Detailed Description

Background:

Depression and the common anxiety disorders are highly prevalent and associated with disability and reduced quality of life. There is reason to believe that the majority of these patients are found in primary care. Official Swedish guidelines dictate that primary care clinics are responsible for treating mild to moderate cases, but access to treatment is limited. Transdiagnostic psychological interventions have been found to be efficacious for anxiety and mood disorders, and require a relatively rudimentary pre-treatment assessment. A large-group transdiagnostic course based on cognitive-behavioral principles may constitute an effective use of limited resources to improve access to treatment, and offer a sufficiently effective intervention, for most primary care patients with mild to moderate mental health problems.

Aim:

To investigate the feasibility and preliminary efficacy of a large-group transdiagnostic intervention for depression and clinically significant anxiety in Swedish primary care.

Design:

This is a prospective single-group feasibility study where 68 adults with clinically significant symptoms of depression or anxiety, and up to 25 adults with subclinical symptoms, are recruited from Liljeholmen primary care clinic, Stockholm, and offered 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing. If necessary, due to the covid-19 pandemic, the course will be held online. The primary outcome is patient satisfaction. Secondary outcomes include within-group effects on psychiatric symptoms (response rates), adherence rates, need for additional treatment, and adverse events.

Conditions

Depression; Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Large-group transdiagnostic course

6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing

Group Type: EXPERIMENTAL

Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material

Intervention Type: BEHAVIORAL

Primarily standard cognitive-behavioral strategies to reduce common psychiatric symptoms

Interventions

Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material

Primarily standard cognitive-behavioral strategies to reduce common psychiatric symptoms

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• At least 8 points on the GAD-7 or 10 points on the PHQ-9 (N=68; up to 25 subclinical participants may also take part in the study)
• At least 18 years old

Exclusion Criteria

• At least one severe mental health problem such as suicidal ideation, a bipolar disorder, or psychosis
• Non-stable antidepressant medication (dosage changed during the past 6 weeks)
• Planned absence for 2 weeks or more of the intended treatment period

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Erland Axelsson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erland Axelsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Liljeholmen primary care clinic

Stockholm, , Sweden

Karolinska Institutet

Stockholm, , Sweden

Countries

Sweden

References

Kolaas K, Berman AH, Hedman-Lagerlof E, Zakrevska A, Epstein M, Hammarberg SAW, Axelsson E. Feasibility of a video-delivered mental health course for primary care patients: a single-group prospective cohort study. BMC Prim Care. 2023 Jan 23;24(1):28. doi: 10.1186/s12875-023-01989-8.

Reference Type: DERIVED

PMID: 36690940 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019-04816

Identifier Type: -

Identifier Source: org_study_id