Trial · NCT07880028
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) Total Score at Week 12 | Baseline and week 12 (end of the 12-week intervention period) | The CORE-OM is a 34-item self-report measure of psychological distress over the past week. Each item is scored from 0 (not at all) to 4 (most or all of the time). Items cover four domains: subjective well-being (4 items), problems and symptoms (12 items), life functioning (12 items), and risk to self or others (6 items). The total score is the mean of completed items multiplied by 10, giving a range of 0 to 40. Higher scores indicate greater psychological distress, so a negative change from baseline indicates improvement. All 34 items are included in the primary total score. The between-arm difference in change from baseline to week 12 is estimated in a linear mixed-effects model adjusted for baseline score and the stratification factors, and reported as an adjusted mean difference with a 95 percent confidence interval. Analysis follows the intention-to-treat principle and includes all randomized participants in the arm to which they were allocated. |
| Secondary | Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score at Week 12 | Baseline to week 12 | The PHQ-9 is a 9-item self-report measure of depressive symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day). The total score is the sum of the nine items and ranges from 0 to 27. Higher scores indicate more severe depressive symptoms, so a negative change from baseline indicates improvement. The between-arm difference in change from baseline to week 12 is estimated in a linear mixed-effects model adjusted for baseline score and the stratification factors, and reported as an adjusted mean difference with a 95 percent confidence interval. No formal adjustment for multiplicity is applied across secondary outcomes; secondary findings are interpreted as supportive rather than confirmatory. |
| Secondary | Change From Baseline in Generalized Anxiety Disorder-7 (GAD-7) Total Score at Week 12 | Baseline to week 12 | The GAD-7 is a 7-item self-report measure of anxiety symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day). The total score is the sum of the seven items and ranges from 0 to 21. Higher scores indicate more severe anxiety symptoms, so a negative change from baseline indicates improvement. The between-arm difference in change from baseline to week 12 is estimated in a linear mixed-effects model adjusted for baseline score and the stratification factors, and reported as an adjusted mean difference with a 95 percent confidence interval. No formal adjustment for multiplicity is applied across secondary outcomes; secondary findings are interpreted as supportive rather than confirmatory. |
| Secondary | Trajectory of Weekly Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) Total Score Across the 12-Week Intervention Period | Baseline and weekly during weeks 1 through 12 | The CORE-OM is a 34-item self-report measure of psychological distress over the past week, scored from 0 (not at all) to 4 (most or all of the time) per item. The total score is the mean of completed items multiplied by 10, giving a range of 0 to 40, with higher scores indicating greater distress. This outcome is the rate of change in total score across the twelve weekly measurements, rather than the change between two timepoints. Trajectories are analysed in a linear mixed-effects model with time modelled continuously and a random slope for participant, and compared between arms through the arm by time interaction. A steeper negative slope indicates faster improvement. |
| Secondary | Change From Baseline in Satisfaction With Life Scale (SWLS) Total Score at Week 12 and 3 Months | Baseline, week 12, and 3 months after baseline | The SWLS is a 5-item self-report measure of global life satisfaction. Each item is scored from 1 (strongly disagree) to 7 (strongly agree). The total score is the sum of the five items and ranges from 5 to 35. Higher scores indicate greater life satisfaction, so a positive change from baseline indicates improvement. Note that the direction of improvement is the opposite of that for the CORE-OM, PHQ-9 and GAD-7. The between-arm difference in change from baseline is estimated at week 12 and at 3 months in a linear mixed-effects model adjusted for baseline score and the stratification factors, and reported as an adjusted mean difference with a 95 percent confidence interval. Both timepoints are randomized comparisons, because no participant in the usual-care arm has started in a group by 3 months. |
| Secondary | Modum Process Outcome Questionnaire (M-POQ) Common Therapeutic Factors Score at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | The M-POQ common factors module is a 14-item self-report measure of outcome expectancy, treatment credibility and therapeutic alliance. Higher scores indicate more favourable ratings of the treatment and of the working relationship with the clinician. Participants in the intervention arm rate the two group leaders jointly; participants in the usual-care arm rate their responsible clinician. There is no baseline measurement, because participants are given time to get to know the clinicians before alliance is rated. Scores are compared between arms at each of the three timepoints in a linear mixed-effects model adjusted for the stratification factors. |
| Secondary | Change From Baseline in Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) Total Score at 3 Months | Baseline and 3 months after baseline | The CORE-OM is a 34-item self-report measure of psychological distress over the past week, scored from 0 (not at all) to 4 (most or all of the time) per item. The total score is the mean of completed items multiplied by 10, giving a range of 0 to 40, with higher scores indicating greater distress and a negative change indicating improvement. This outcome assesses whether any difference between arms is retained after the intervention period ends. The 3-month assessment is a randomized comparison: group cycles begin three times a year, so no participant allocated to usual care has started in a group by this timepoint, and the arms remain as randomized. The between-arm difference in change from baseline is estimated in a linear mixed-effects model adjusted for baseline score and the stratification factors. |
| Secondary | Change From Baseline in Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) Total Score at 6 Months | Baseline and 6 months after baseline | The CORE-OM is a 34-item self-report measure of psychological distress over the past week, scored from 0 (not at all) to 4 (most or all of the time) per item. The total score is the mean of completed items multiplied by 10, giving a range of 0 to 40, with higher scores indicating greater distress and a negative change indicating improvement. This outcome describes the durability of change within each arm. By 6 months a proportion of participants allocated to usual care have started in the group program as ordinary clinical treatment, outside the research design, so the arms are no longer as randomized. Change is therefore analysed within arm, and any between-arm contrast at this timepoint is reported descriptively together with the number and timing of usual-care participants who have started in a group. No hypothesis is specified at 6 months. |
| Other | Association Between In-Session Heart Rate Variability and Change in Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) Total Score to Week 12 | During each of the 12 weekly group sessions, and CORE-OM at baseline and week 12 | Heart rate variability is recorded continuously during group sessions using a chest-worn heart rate sensor, and summarized as the root mean square of successive differences (RMSSD) and the standard deviation of normal-to-normal intervals (SDNN), both in milliseconds. Higher values indicate greater vagally mediated autonomic regulation. Recording is available in the intervention arm only, because sensors are worn during group sessions, and supports no between-arm comparison. Use of a sensor is voluntary and is decided by the participant session by session, so the subsample may under-represent the most sensory-sensitive participants. Within the intervention arm, the association between early change in heart rate variability and change in CORE-OM total score to week 12 is estimated and reported with an effect size and a 95 percent confidence interval. This analysis is exploratory and hypothesis-generating. |
| Other | Baseline Self-Reported Irritability as a Moderator of Change in Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) Total Score to Week 12 | Baseline, with change in CORE-OM measured from baseline to week 12 | Irritability is measured with two self-report items on affective reactivity, each scored 0 (not true), 1 (somewhat true) or 2 (certainly true), giving a score from 0 to 4. Higher scores indicate greater irritability. The baseline score is entered as a moderator of change in CORE-OM total score from baseline to week 12, across both arms, through an interaction term in a linear mixed-effects model. The measure is repeated at week 12 for descriptive purposes only; no change over the intervention period is hypothesized. Results are reported with an effect size and a 95 percent confidence interval. This analysis is exploratory and hypothesis-generating. |
| Other | Baseline Self-Reported Autistic Traits (Autism-Spectrum Quotient) as a Moderator of Change in Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) Total Score to Week 12 | Baseline, with change in CORE-OM measured from baseline to week 12 | The Autism-Spectrum Quotient is a 50-item self-report measure of autistic traits in adults of typical intellectual ability. Each item is scored 0 or 1 under standard scoring, giving a total from 0 to 50, with higher scores indicating more self-reported autistic traits. The measure is administered once, at baseline, and is retrieved from the patient record where the participant has completed it previously. The baseline score is entered as a moderator of change in CORE-OM total score from baseline to week 12 through an interaction term in a linear mixed-effects model, and reported with an effect size and a 95 percent confidence interval. This analysis is exploratory and hypothesis-generating. |
| Other | Participant-Reported Experience of the Group Program, Assessed by Weekly Free-Text Responses | Weekly during weeks 1 through 12 | Participants in the intervention arm answer five open-ended questions after each group session, covering what they learned, what they found helpful, and anything they did not like or would have wanted different. Responses are short and structured by the question. They are summarized descriptively and reported by session number, so that it is apparent which components of the program participants found usable and what they would change. No interpretative coding framework is applied, because the material is too brief to support one. Responses are de-identified before analysis. This outcome characterizes acceptability and experience and is not used to support claims about treatment effect. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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