A Transdiagnostic Course for Common Mental Health Problems in Primary Care

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04522713
• Other study ID #: 2019-04816
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 3, 2021

Study information

• Verified date: March 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 3, 2021
• Est. primary completion date: December 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

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

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm
Sweden	Liljeholmen primary care clinic	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction with treatment as indicated by a 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-treatment assessment (immediately after treatment, completed within 45 days)
Secondary	Adherence operationalized as the average number of completed sessions	Session attendance registered once each week by a clinician during the treatment period	From week 1 to week 6
Secondary	At least 1/3 patients reporting a clinically significant improvement in symptoms of depression	Dichotomous outcome (Jacobson & Truax, 1991) based on the Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, higher score indicates more symptoms of depression)	Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Secondary	At least 1/3 patients reporting a clinically significant improvement in symptoms of general anxiety	Dichotomous outcome (Jacobson & Truax, 1991) based on the GAD-7 (theoretical range: 0-21, higher score indicates more general anxiety)	Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Secondary	Change in lifestyle behaviors		Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Secondary	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
Secondary	Proportion of patients in need of additional treatment	Clinical interview	Post-treatment assessment (within 45 days after treatment)
Secondary	Average change in symptoms of depression	Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, higher score indicates more symptoms of depression)	Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Secondary	Average change in general anxiety	GAD-7 (theoretical range: 0-21, higher score indicates more general anxiety)	Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Secondary	Average change in perceived stress	Perceived Stress Scale, 10-item version (PSS-10, theoretical range: 0-40, higher score indicates more perceived stress)	Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Secondary	Average change in disability	World Health Organization Disability Assessment Schedule 2.0 (WHODAS-2, theoretical range: 0-100, higher score indicates more disability)	Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)