A Transdiagnostic Course for Common Mental Health Problems in Primary Care

Single-Arm Feasibility Study of a Transdiagnostic Course for Common Mental Health Problems in Primary Care

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material

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.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17165
    • Karolinska Institutet
  • Stockholm, Sweden, 11763
    • Liljeholmen primary care clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Satisfaction With Treatment	Preregistered target: mean Client Satisfaction Questionnaire (CSQ-8) score of at least 22. Theoretical range: 8-32, higher score indicates higher satisfaction. This sum score is based on 8 items, each scored 1-4. The original preregistered range of 7-28 was an erratum.	Post-course assessment (immediately after the course, completed within 45 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence Operationalized as the Average Number of Attended Lectures	Attendance, i.e., participation in the course, registered once each week, after each course date, by a clinician during the course period	From week 1 to week 6
Number of Participants With Clinically Significant Improvement in Symptoms of Depression	Preregistered target: At least 1/3 patients reporting a clinically significant improvement in symptoms of depression. Dichotomous outcome based on the Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, higher score indicates more symptoms of depression). Clinically significant improvement implied a reduction of at least 6 points on the PHQ-9 in combination with a post-course score below 10.	Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
Number of Participants With Clinically Significant Improvement in General Anxiety	Preregistered target: At least 1/3 patients reporting a clinically significant improvement in general anxiety. Dichotomous outcome based on the GAD-7 (theoretical range: 0-21, higher score indicates more general anxiety). Clinically significant improvement implied a reduction of at least 5 points on the GAD-7 in combination with a post-course score below 8.	Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
Number of Participants With Problematic Lifestyle Behaviors	Lifestyle behaviors were measured using the Lifestyle Behaviors Questionnaire (LBQ) which comprises 11 items that cover tobacco use, alcohol use, physical activity and diet. Dichotomous risky lifestyle behavior variables were derived from the LBQ in terms of: "At least one unhealthy lifestyle behavior", "Daily smoking", "Binge drinking more than once a month OR more than 9/14 (w/m) glasses/week", "Insufficient physical activity, less than 150 minutes/week", and "Notably unhealthy dietary habits (diet index 0-4)". Risky lifestyle behavior was defined as daily smoking, binge drinking of 4/5 (women/men) drinks at one occasion more than once a month and/or more than 9/14 (women/men) standard glasses of alcohol weekly, insufficient physical activity (<150 minutes/week) or significantly unhealthy diet habits (a score of 0-4 on a diet index in the questionnaire, ranging from 0-12).	Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
Number of Adverse Events	Weekly question: "Since the last assessment, have you experienced any adverse event, side effect, or unwanted effect of your participation in this study?"	From week 1 to week 6
Percentage of Patients in Need of Additional Clinical Intervention	Clinical interview	Post-course assessment (within 45 days after the course)
Change in Mean Symptoms of Depression From Pre- to Post-Course Assessment	Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, higher score indicates more symptoms of depression). Efficacy outcomes based on linear mixed models.	Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
Change in Mean General Anxiety From Pre- to Post-Course Assessment	GAD-7 (theoretical range: 0-21, higher score indicates more general anxiety). Efficacy outcomes based on linear mixed models.	Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
Change in Mean Perceived Stress From Pre- to Post-Course Assessment	Perceived Stress Scale, 10-item version (PSS-10, theoretical range: 0-40, higher score indicates more perceived stress). Efficacy outcomes based on linear mixed models.	Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)
Change in Mean Disability From Pre- to Post-Course Assessment	World Health Organization Disability Assessment Schedule 2.0 (WHODAS-2, theoretical range: 0-100, higher score indicates more disability). Efficacy outcomes based on linear mixed models.	Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm
• Investigators: Principal Investigator: Erland Axelsson, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): December 3, 2021
• Study Completion (Actual): December 3, 2021

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Feasibility; Primary care; Transdiagnostic
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2019-04816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are willing to consider reasonable requests for individual participant data (IPD) and to consult the responsible parties accordingly. However, we do not expect to be granted permission to share IPD as long as, under Swedish and European Union (EU) data protection and privacy legislation, the IPD constitutes personal data meaning that it is possible to, using the study database, link the IPD to an identifiable living natural person.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No