A Transdiagnostic Course for Common Mental Health Problems in Primary Care

NCT04522713 | Completed Results

• 1 other identifier: 2019-04816
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression; Anxiety

Keywords

Transdiagnostic; Primary care; Feasibility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Adherence Operationalized as the Average Number of Attended Lectures

  From week 1 to week 6

• Number of Participants With Clinically Significant Improvement in Symptoms of Depression

  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

  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

  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

  From week 1 to week 6

Study Arms (1)

Large-group transdiagnostic course

EXPERIMENTAL

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

Interventions

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

Primarily standard cognitive-behavioral strategies to reduce common psychiatric symptoms

Large-group transdiagnostic course

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (2)

Liljeholmen primary care clinic

Stockholm, 11763, Sweden

Location

Karolinska Institutet

Stockholm, 17165, Sweden

Location

Related Publications (1)

• 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.

  PMID: 36690940 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Limitations and Caveats

There was no control group, which implies that it is unclear if effects were causal. Patient satisfaction was not explored using qualitative methods.

Results Point of Contact

• Title: Dr. Erland Axelsson
• Organization: Karolinska Institutet

erland.axelsson@ki.se

0706171039

Study Officials

• Erland Axelsson, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Psychological intervention, self-report outcomes
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective single-group cohort study

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 21, 2020
• Study Start: September 1, 2020
• Primary Completion: December 3, 2021
• Study Completion: December 3, 2021
• Last Updated: January 31, 2025
• Results First Posted: January 31, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)