The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Older Adults: a Feasibility Study
NCT06777693, Not applicable, Enrolling by invitation, NKS Olaviken Gerontopsychiatric Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Older Adults: a Feasibility Study | ClinicalTrials.gov |
| NCT number | NCT06777693 | ClinicalTrials.gov |
| Status | Enrolling by invitation | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 24 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | NKS Olaviken Gerontopsychiatric Hospital | ClinicalTrials.gov |
| Conditions | Emotional Disorders | ClinicalTrials.gov |
| Interventions | Unified Protocol | ClinicalTrials.gov |
| First posted | 2025-01-16 | ClinicalTrials.gov |
| Last updated | 2025-01-16 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Qualitative interviews | Immediately after the intervention | Qualitative interviews relating to implementation, service and client outcomes will be conducted after the group treatment has finished. The interviews will focus on the participants experience with the feasibility of the interventions, especially regarding acceptability and adaptation as defined by Bowen and colleagues (2009). | ClinicalTrials.gov |
| Primary | Overall well-being | Baseline, and immediately after the intervention | We use the World Health Organization Well-Being Index-5 (WHO-5, Topp et al., 2015) to measure overall subjective well-being. Scores range from 0-25 where higher scores indicate more well-being. | ClinicalTrials.gov |
| Primary | Geriatric Anxiety Inventory (GAI) | Baseline, after six weeks and immediately after the intervention | Questionaire used to measure anxiety symptom severity in older adults. Higher scores (from 0-20) indicate higher symptom severity. | ClinicalTrials.gov |
| Primary | Generalized Anxiety Disorder Questionaire (GAD-7) | Baseline, after six weeks and immediately after the intervention | Questionaire used to measure symptoms of generalized anxiety. Scores range from 0-21 where higher scores indicate higher symptom severity. The questionaire also ask how much these symptoms impact the persons ability to fuction effectively in every day activities. | ClinicalTrials.gov |
| Primary | Montgomery And Åsberg Depression Rating Scale (MADRS) | Baseline, after six weeks and immediately after the intervention | Questionaire used to examine symptoms of depression as well as the severity of the symptoms. Scores range from 0-60 where higher scores indicate more depressive symptoms | ClinicalTrials.gov |
| Primary | Credibility/Expectancy Questionaire (CEQ) | Baseline, after six weeks and immediately after the intervention | Test the participants expectancy and believes on whether the treatment will be helpful. Scores range from 6-51 where higher scores indicate higher beliefs and expectancy that the treatment will be helpful. | ClinicalTrials.gov |
| Primary | Overall Depression Severity and Impairment Scale (ODSIS) | Weekly, before every session for 12 weeks | Questionaire developed as part of the UP manual used to track depression symptoms and their effect on function. Scores range from 0-20 where higher scores indicate higher symptom severity. | ClinicalTrials.gov |
| Primary | Overall Anxiety Severity and Impairment Scale (OASIS) | Weekly, before every session for 12 weeks | Questionaire developed as part of the UP manual used to track anxiety symptoms and their effect on function. Scores range from 0-20 where higher scores indicate higher symptom severity. | ClinicalTrials.gov |
| Primary | The Norwegian Acceptance and Action Questionnaire version 2 (NAAQ-2) | Baseline, after six weeks and immediately after the intervention | Measure the psychological flexibility of the participants. Higher scores (range 7-49) indicate lower levels of cognitive flexibility. | ClinicalTrials.gov |
| Primary | Negative Effects Questionnaire (NEQ) | Immediately after the intervention | After the treatment, the participants are assessed using the Negative Effects Questionnaire to detect any adverse effects of the psychotherapy. These will be triangulated with the results from qualitative interviews assessing the experiences of the treatment. The scores is not numerical, but detects and describes any potential negative events from the treatment. | ClinicalTrials.gov |
| Primary | GeneActive Actigraph | During week 1, week 6 and week 12 of treatment procedure | To register the participants' sleep and the 24-hour rest-activity-rhythm, we will use actigraphy. The actigraph (GeneActive) has been validated for use in older adults. It will be placed on the participants' non-dominant wrist. | ClinicalTrials.gov |
| Primary | The National Adult Reading Test (NART) | At baseline and immediately after the intervention | Measure of general intelligence shown to correlate highly with premorbid intelligence. Scores range from 0-50 and will be reported as predicting premorbide intelligence below the average, on the average or above the average. | ClinicalTrials.gov |
| Primary | 20 questions | Baseline, and immediately after the intervention | The ability of abstract thinking and cognitive flexibility is assessed using 20 questions from Delis Kapln Executive Function system. Scores are reported as scaled scores below average, on average or above average. | ClinicalTrials.gov |
| Primary | Stroop test | Baseline, and immediately after the intervention | Assesses the participants skills of inhibition. The scores are reported as scaled scores below average, on average or above average. | ClinicalTrials.gov |
| Primary | Numbers from WAIS-IV | Baseline, and immediately after the intervention | Numbers from the Wechsler Adult Intelligence Scale will be used to assess the participants working memory. Scores are reported as scaled scores below average, on average or above average. | ClinicalTrials.gov |
| Primary | Trail Making Test B (TMT-B) | Immediately after the intervention | TMT-B is used in the post-treatment measure, assessing cognitive shifting and psychomotoric tempo. Scales are reported as t-scores which fall below average, on average or above average. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)