Trial Outcomes & Findings for A Transdiagnostic Course for Common Mental Health Problems in Primary Care (NCT NCT04522713)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

91 participants

Primary outcome timeframe

Post-course assessment (immediately after the course, completed within 45 days)

Results posted on

2025-01-31

Participant Flow

We intended to recruit 68 participants with clinically significant depression or anxiety, and up to 25 participants with subclinical depression and anxiety. When the target of 68 clinical participants had been met, the remaining scheduled eligibility interviews were completed for ethical reasons, which resulted in a final clinical sample size of 70. By that time, 21 subclinical participants had been enrolled, which resulted a total sample size of 91.

All participants were enrolled in the course.

Participant milestones

Participant milestones
Measure	Large-group Transdiagnostic Course All participants took part in the same intervention, and were analyzed as one group. There were no subgroups receiving separate interventions. 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing 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
Overall Study STARTED	91
Overall Study COMPLETED	86
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Large-group Transdiagnostic Course n=91 Participants 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing 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
Age, Continuous	38 years STANDARD_DEVIATION 12 • n=91 Participants
Sex: Female, Male Female	63 Participants n=91 Participants
Sex: Female, Male Male	28 Participants n=91 Participants
Region of Enrollment Sweden	91 participants n=91 Participants
University education	71 Participants n=91 Participants
Employment Working full-time	55 Participants n=91 Participants
Employment Working part-time (< 90%)	11 Participants n=91 Participants
Employment Unemployed	3 Participants n=91 Participants
Employment Retired	3 Participants n=91 Participants
Employment Student	9 Participants n=91 Participants
Employment Other	10 Participants n=91 Participants

PRIMARY outcome

Timeframe: Post-course assessment (immediately after the course, completed within 45 days)

Population: The trial included 91 participants: 70 clinical, and 21 subclinical. Of these, 86 (66 + 20) completed the CSQ-8 at the post-course assessment.

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.

Outcome measures

Outcome measures
Measure	Large-group Transdiagnostic Course n=86 Participants 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing 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
Overall Satisfaction With Treatment Pooled sample (primary)	22 score on a scale Standard Deviation 4
Overall Satisfaction With Treatment Clinical subsample	21 score on a scale Standard Deviation 4
Overall Satisfaction With Treatment Subclinical subsample	23 score on a scale Standard Deviation 3
Overall Satisfaction With Treatment Participants without previous experience of psychological treatment	23 score on a scale Standard Deviation 4
Overall Satisfaction With Treatment Participants with previous experience of psychological treatment	21 score on a scale Standard Deviation 4

SECONDARY outcome

Timeframe: From week 1 to week 6

Attendance, i.e., participation in the course, registered once each week, after each course date, by a clinician during the course period

Outcome measures

Outcome measures
Measure	Large-group Transdiagnostic Course n=91 Participants 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing 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
Adherence Operationalized as the Average Number of Attended Lectures	5.0 lectures attended Standard Deviation 1.6

SECONDARY outcome

Timeframe: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)

Population: For depression symptoms, only those who had a score of at least 10 on the PHQ-9 at baseline could potentially be classified as clinically significant improved. This was done to ensure that the clinical cut-off was not too liberal and also that all participants scored in the clinical range at baseline.

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.

Outcome measures

Outcome measures
Measure	Large-group Transdiagnostic Course n=46 Participants 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing 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
Number of Participants With Clinically Significant Improvement in Symptoms of Depression	22 Participants

SECONDARY outcome

Timeframe: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)

Population: For general anxiety, only those who had a score of at least 8 on the GAD-7 at baseline could potentially be classified as clinically significant improved. This was done to ensure that the clinical cut-off was not too liberal and also that all participants scored in the clinical range at baseline.

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.

Outcome measures

Outcome measures
Measure	Large-group Transdiagnostic Course n=46 Participants 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing 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
Number of Participants With Clinically Significant Improvement in General Anxiety	27 Participants

SECONDARY outcome

Timeframe: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)

Population: 86/91 participants completed the post-course assessment

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).

Outcome measures

Outcome measures
Measure	Large-group Transdiagnostic Course n=91 Participants 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing 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
Number of Participants With Problematic Lifestyle Behaviors Pre-course: At least one unhealthy lifestyle behavior	40 Participants
Number of Participants With Problematic Lifestyle Behaviors Post-course: At least one unhealthy lifestyle behavior	36 Participants
Number of Participants With Problematic Lifestyle Behaviors Pre-course: Daily smoking	2 Participants
Number of Participants With Problematic Lifestyle Behaviors Post-course: Daily smoking	2 Participants
Number of Participants With Problematic Lifestyle Behaviors Pre-course: Binge drinking more than once a month OR more than 9/14 (w/m) glasses/week	17 Participants
Number of Participants With Problematic Lifestyle Behaviors Post-course: Binge drinking more than once a month OR more than 9/14 (w/m) glasses/week	15 Participants
Number of Participants With Problematic Lifestyle Behaviors Pre-course: Insufficient physical activity, less than 150 minutes/week	22 Participants
Number of Participants With Problematic Lifestyle Behaviors Post-course: Insufficient physical activity, less than 150 minutes/week	22 Participants
Number of Participants With Problematic Lifestyle Behaviors Pre-course: Notably unhealthy dietary habits (diet index 0-4)	11 Participants
Number of Participants With Problematic Lifestyle Behaviors Post-course: Notably unhealthy dietary habits (diet index 0-4)	15 Participants

SECONDARY outcome

Timeframe: From week 1 to week 6

Population: 86/91 participants completed the post-course assessment at week 6

Weekly question: "Since the last assessment, have you experienced any adverse event, side effect, or unwanted effect of your participation in this study?"

Outcome measures

Outcome measures
Measure	Large-group Transdiagnostic Course n=86 Participants 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing 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
Number of Adverse Events	9 adverse events reported

SECONDARY outcome

Timeframe: Post-course assessment (within 45 days after the course)

Population: 81/91 completed the post-course interview

Clinical interview

Outcome measures

Outcome measures
Measure	Large-group Transdiagnostic Course n=81 Participants 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing 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
Percentage of Patients in Need of Additional Clinical Intervention	44 Participants

SECONDARY outcome

Timeframe: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)

Population: 70 clinical, 21 subclinical

Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, higher score indicates more symptoms of depression). Efficacy outcomes based on linear mixed models.

Outcome measures

Outcome measures
Measure	Large-group Transdiagnostic Course n=91 Participants 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing 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
Change in Mean Symptoms of Depression From Pre- to Post-Course Assessment Clinical subsample	-4.8 units on a scale Interval -6.1 to -3.4
Change in Mean Symptoms of Depression From Pre- to Post-Course Assessment Subclinical subsample	-1.5 units on a scale Interval -2.8 to -1.5

SECONDARY outcome

Timeframe: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)

Population: 70 clinical, 21 subclinical

GAD-7 (theoretical range: 0-21, higher score indicates more general anxiety). Efficacy outcomes based on linear mixed models.

Outcome measures

Outcome measures
Measure	Large-group Transdiagnostic Course n=91 Participants 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing 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
Change in Mean General Anxiety From Pre- to Post-Course Assessment Clinical subsample	-3.8 units on a scale Interval -5.0 to -2.6
Change in Mean General Anxiety From Pre- to Post-Course Assessment Subclinical subsample	-1.2 units on a scale Interval -2.3 to -0.6

SECONDARY outcome

Timeframe: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)

Population: 70 clinical, 21 subclinical

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.

Outcome measures

Outcome measures
Measure	Large-group Transdiagnostic Course n=91 Participants 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing 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
Change in Mean Perceived Stress From Pre- to Post-Course Assessment Clinical subsample	-3.3 units on a scale Interval -4.6 to -1.9
Change in Mean Perceived Stress From Pre- to Post-Course Assessment Subclinical subsample	-1.5 units on a scale Interval -4.2 to 1.2

SECONDARY outcome

Timeframe: Pre-course assessment (within 2 weeks before the course) to post-course assessment (immediately after the course, completed within 45 days)

Population: 70 clinical, 21 subclinical

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.

Outcome measures

Outcome measures
Measure	Large-group Transdiagnostic Course n=91 Participants 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing 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
Change in Mean Disability From Pre- to Post-Course Assessment Clinical subsample	-4.1 units on a scale Interval -7.1 to -1.1
Change in Mean Disability From Pre- to Post-Course Assessment Subclinical subsample	0.4 units on a scale Interval -4.3 to 5.1

Adverse Events

Large-group Transdiagnostic Course

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Large-group Transdiagnostic Course n=86 participants at risk；n=91 participants at risk 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing 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
Psychiatric disorders Temporary increase in anxiety or stress	3.5% 3/86 • Number of events 3 • 6-week course period At the post-course assessment, we assessed adverse events using free-text items where the respondent could report up to three adverse events, describe these in free text, and rate how much each adverse event had affected them negatively at the time it occurred, and still affected them negatively at the post-course assessment.
Psychiatric disorders Other	7.0% 6/86 • Number of events 6 • 6-week course period At the post-course assessment, we assessed adverse events using free-text items where the respondent could report up to three adverse events, describe these in free text, and rate how much each adverse event had affected them negatively at the time it occurred, and still affected them negatively at the post-course assessment.

Additional Information

Dr. Erland Axelsson

Karolinska Institutet

Phone: 0706171039

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place