Unified Protocol: 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.
Study 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.
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
* Stable use of psychotropic medication for the last month. Periodic use of z-hypnotics is not exclusion criteria but will be restricted to a limited and pre-planned dosage per week. Stabilization of psychotropic medication can be offered to eligible patients before participation.
* Prepared to share their challenges and work on maladaptive emotion regulation strategies in a group setting.
* Able to attend most sessions.
Exclusion Criteria:
* 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
* Habitual use of prescribed anxiolytics or opiods. Help with gradual reduction and elimination before inclusion in treatment will be offered to potential participants
* 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
Primary outcome measure(s)
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).
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
