N/A
N=91
A Transdiagnostic Course for Common Mental Health Problems in Primary Care
Depression · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT04522713 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Overall Satisfaction With Treatment — 22; 21; 23; 23 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Karolinska Institutet
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Satisfaction With Treatment |
22; 21; 23; 23; 21 | — |
| SECONDARY Adherence Operationalized as the Average Number of Attended Lectures |
5.0 | — |
| SECONDARY Number of Participants With Clinically Significant Improvement in Symptoms of Depression |
22 | — |
| SECONDARY Number of Participants With Clinically Significant Improvement in General Anxiety |
27 | — |
| SECONDARY Number of Participants With Problematic Lifestyle Behaviors |
40; 36; 2; 2; 17; 15 | — |
| SECONDARY Number of Adverse Events |
9 | — |
| SECONDARY Percentage of Patients in Need of Additional Clinical Intervention |
44 | — |
| SECONDARY Change in Mean Symptoms of Depression From Pre- to Post-Course Assessment |
-4.8; -1.5 | — |
| SECONDARY Change in Mean General Anxiety From Pre- to Post-Course Assessment |
-3.8; -1.2 | — |
| SECONDARY Change in Mean Perceived Stress From Pre- to Post-Course Assessment |
-3.3; -1.5 | — |
| SECONDARY Change in Mean Disability From Pre- to Post-Course Assessment |
-4.1; 0.4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04522713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.