The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Older Adults: a Feasibility Study

NCT06777693 | Enrolling By Invitation

• 1 other identifier: 769706
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Psychological treatment is less likely to be offered in an older population. In order to adapt treatment effectively for this population, more research is necessary. This study will investigate the feasibility of Unified Protocol Senior (65 years and older) in a group format. Patients with emotional disorders (i.e. anxiety or depression) is offered diagnostic and cognitive evaluations, two individual sessions and twelve group sessions lasting 2 hours. The participants psychological symptoms will be examined pre-, during- and post-treatment. Qualitative interviews will be conducted after treatment in order to understand the participants experience of and outcome of the treatment. The study will investigate whether any unwanted experiences occurred during treatment. The study is planning on carrying out four seperate treatmentgroups consisting of 6-8 patients. Information gathered from one group will be used to adapt the group sessions for the consecutive treatment group. This will be done until a feasible format is reached.

Conditions

Emotional Disorders

Keywords

Emotional disorders; Anxiety; Depression; Avoidant coping; Neuroticism

Outcome Measures

Primary Outcomes (16)

• Qualitative interviews

  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).

  Immediately after the intervention

• Overall well-being

  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.

  Baseline, and immediately after the intervention

• Geriatric Anxiety Inventory (GAI)

  Questionaire used to measure anxiety symptom severity in older adults. Higher scores (from 0-20) indicate higher symptom severity.

  Baseline, after six weeks and immediately after the intervention

• Generalized Anxiety Disorder Questionaire (GAD-7)

  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.

  Baseline, after six weeks and immediately after the intervention

• Montgomery And Åsberg Depression Rating Scale (MADRS)

  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

  Baseline, after six weeks and immediately after the intervention

• Credibility/Expectancy Questionaire (CEQ)

  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.

  Baseline, after six weeks and immediately after the intervention

• Overall Depression Severity and Impairment Scale (ODSIS)

  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.

  Weekly, before every session for 12 weeks

• Overall Anxiety Severity and Impairment Scale (OASIS)

  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.

  Weekly, before every session for 12 weeks

• The Norwegian Acceptance and Action Questionnaire version 2 (NAAQ-2)

  Measure the psychological flexibility of the participants. Higher scores (range 7-49) indicate lower levels of cognitive flexibility.

  Baseline, after six weeks and immediately after the intervention

• Negative Effects Questionnaire (NEQ)

  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.

  Immediately after the intervention

• GeneActive Actigraph

  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.

  During week 1, week 6 and week 12 of treatment procedure

• The National Adult Reading Test (NART)

  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.

  At baseline and immediately after the intervention

• 20 questions

  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.

  Baseline, and immediately after the intervention

• Stroop test

  Assesses the participants skills of inhibition. The scores are reported as scaled scores below average, on average or above average.

  Baseline, and immediately after the intervention

• Numbers from WAIS-IV

  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.

  Baseline, and immediately after the intervention

• Trail Making Test B (TMT-B)

  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.

  Immediately after the intervention

Study Arms (1)

Treatment group

OTHER

The treatment follows the translation of the Danish manual of the group version of UP, with 12 group sessions. Each group will consist of up to eight participants, and two therapists trained in UP. Diagnostic assessment and screening are conducted in the clinic before inclusion, but one session is reserved for baseline assessment and neuropsychological testing before participating in the intervention. Initially, the participants will have two individual sessions, including the case formulation and the goal-setting session of UP. Then, the participants will undergo the Unified Protocol in a group format, consisting of weekly sessions over 11 weeks and a booster session after one month. Post-assessment is conducted within the first 14 days after the last group session.

Behavioral: Unified Protocol

Interventions

Unified Protocol BEHAVIORAL

The Unified Protocol group format involves 12 sessions focusing on goal setting and motivation, understanding emotions, mindful emotion awareness, cognitive flexibility, countering emotionat behaviours, understanding and confronting physical sensations, emotion exposure and relapse prevention. The UP model directly approaches the patient\'s emotion regulation by focusing on cognitive flexibility, exposure exercises, mindful awareness, acceptance, and other evidence-based therapeutic approaches known from cognitive-behavioural therapy (CBT), emotion-focused therapy (EFT) and mindfulness-based interventions.

Treatment group

Eligibility Criteria

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

You may qualify if:

• Clinically significant symptoms of anxiety or depression based on self-report and clinical interview
• Score on the MMSE-NR above 26 and competent to give informed consent as evaluated by a structural clinical assessment

You may not qualify if:

• Prepared to share their challenges and work on maladaptive emotion regulation strategies in a group setting.
• Able to attend most sessions.
• Conditions requiring specialized treatment such as active psychosis and/or mania, untreated or unstable bipolar disorder, psychosis spectrum disorders or severe depressive episode
• Acutely increased risk of suicide or deliberate self-harm
• Dementia or amnestic mild cognitive impairment
• Substance abuse including psychoactive drugs
• Uncorrected hearing loss
• Symptoms of personality disorders that hinder participation in the group
• Simultaneously participating in other psychotherapy
• Living with ongoing highly social burden where greater flexibility in treatment is needed

Sponsors & Collaborators

• NKS Olaviken Gerontopsychiatric Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

NKS NKS Olaviken Gerontopsychiatric Hospital

Bergen, Vestland, 5009, Norway

Location

Related Publications (3)

• Barlow DH, Allen LB, Choate ML. Toward a Unified Treatment for Emotional Disorders - Republished Article. Behav Ther. 2016 Nov;47(6):838-853. doi: 10.1016/j.beth.2016.11.005. Epub 2016 Nov 10.

  PMID: 27993336 BACKGROUND

• Braun, V., Clarke, V., Hayfield, N., Terry, G. (2019). Thematic analysis. In Handbook of Research Methods in Health Social Sciences (pp. 843-860). Springer.

  BACKGROUND

• Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.

  PMID: 19362699 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Kristine G Madsø, Clinical Psychology (PhD)

  NKS Olaviken Gerontopsychiatric Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study aims to investigate the feasibility of the Unified Protocol for old adults (older than 65) in an outpatient clinic in terms of the four aspects; acceptance and percieved helpfulness, practical feasibility, reliable change and iterative modifications.

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: January 16, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)