Emotional DisordersUPSNCT06777693
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Older Adults: a Feasibility Study
A study testing Unified Protocol in people with Emotional Disorders, run by NKS Olaviken Gerontopsychiatric Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Emotional Disorders
- What is being tested?
- Unified Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2024to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site
NKS NKS Olaviken Gerontopsychiatric Hospital
Bergen, Vestland, 5009
About this study
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.
Read the detailed description
Emotional disorders such as anxiety and depression are the most common mental health problems affecting older people, and are highly comorbid . The prevalence is high (greater than 25 %), with increasing prevalence for people with comorbid somatic disorders (greater than 40%). Evidence suggests that psychological treatment for older adults is as effective as for working-age adults and maybe even more effective in old adults with comorbid somatic disorders. Despite this, older adults are generally under-represented in psychological services.
Most older adults with emotional disorders receive psychopharmacological treatment as the first choice, even when national and clinical guidelines suggest offering psychological treatment as a first choice or combining medication and psychological treatment. Studies show that adults older than 65 prefer psychological therapy over psychotropic medication. Choosing psychological treatment also decreases risks associated with polypharmacy. Evidence shows that psychological treatment for common mental health problems in people older than 65 is effective. Implementing effective and available psychological treatment for people older than 65 in Norway is challenging, primarily due to lack of referral to mental health care units despite the guidance of priority for public mental health services recommend stressing the severity of symptoms and not age itself. Negative consequences for untreated mental health problems in older adults can have significant consequences on overall well-being, ranging from social isolation, cognitive decline, increased risk of suicide and exacerbating existing medical conditions. Thus, making evidence-based psychological services available for older adults is a highly relevant goal to achieve.
A key barrier challenging the implementation of evidence-based psychological treatment is that implementing diagnosis-specific protocols is not very well suited to the clinical settings where comorbidity and complexity are the norm. This is not specific for mental health care for people older than 65, implementing evidence-based psychological treatment is challenging in the health care systems in general. Accordingly, transdiagnostic treatment protocols have been developed over the last decades, where the treatment model targets underlying processes and mechanisms across different, but commonly comorbid, diagnoses. Barlow and colleagues have developed the "Unified protocol for transdiagnostic treatment of emotional disorders" in response to this issue. The Unified Protocol (UP) has shown promising results in treating anxiety and depression in various populations. However, its efficacy in older adults (older than 65 years) remains understudied. This is not specific to UP; most treatment protocols and outcome scales used in mental health care for adults are mainly developed for adults of working age and not adapted for the specific issues in late adulthood where immobility and social isolation, comorbid somatic disorders, and impaired executive functioning are more common. Given that psychological treatments for common mental health problems in people older than 65 are effective when adjusted to the needs of the population, investigating the feasibility of transdiagnostic treatments such as UP seems highly relevant. UP's theoretical foundations for development and maintenance of emotional disorders also seems transferable to our specific population, as described in the following section.
The transdiagnostic model of Unified Protocol According to UP, a typical shared personality dimension or temperament of people with emotional disorders is the vulnerability dimension of neuroticism, contributing to experience negative emotions with high intensity. People high in neuroticism tend to perceive these emotions as highly uncontrollable and dangerous, something that should be avoided. In sum, these negative emotions place the person at risk for persistent mental health problems. Two central processes may then contribute to the development of emotional disorders such as anxiety or depression. The first is the tendency to react aversively to intense emotional experiences. The second is the tendency for avoidant coping. UP targets both the vulnerability dimension of neuroticism and the dysfunctional coping of strong emotions. Further, 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-behavioral therapy (CBT), emotion-focused therapy, and mindfulness-based interventions. Patients learn to understand their emotional experiences, observe them without judgment, stop avoidant coping, and change their behaviour toward reaching their goals. Avoiding negative stimuli is a common coping strategy for emotion regulation in old adults, but not all stressors may be avoided. Thus, learning to cope with emotional experiences through exposure as the theoretical foundation of UP suggests, seems transferable to our population. Clinical guidelines on emotional disorders, anxiety and depression in old adults also stress increasing the level of activity and break social isolation as important goals of treatment. Even if neural deterioration will occur with age, there is a potential of neuroplasticity and participants may still learn new behaviours and change in response to new experiences. However, identifying the older patient that will benefit from UP will probably require a wider initial assessment of cognitive functions (memory and executive function) and somatic condition (pharmacological treatment and somatic disorders potentially presenting as psychiatric symptoms).
Objectives UP has been investigated in large trials with promising results. A 14- session Group-based UP is currently implemented, and its feasibility is systematically evaluated in Norway in an adult population (18-40 years). There is an increasing expertise in western Norway on the method. There are also clinical experiences with an eight-session group based UP with older adults from a Geriatric Psychiatric Clinic (Äldrepsykiatrisk mottagning), Sahlgrenska Universitetssjukhuset (Gothenburg, Sweeden) where one found some effect on depressive symptoms and anxiety. Foremost, the participants with the best treatment effect changed the way they related to their thoughts and feelings (their psychological flexibility). As one participant said:" I can recognize my weak spots better. That is a window for change. When I recognize the patterns that are bad for me, it gives me the possibility to change them. I have learned a lot about emotions. I understand so much more, I recognize things that are not helpful to me." Experiences from these groups led the therapists to adapt the original manual and use less worksheets, practice mindful emotion awareness throughout the treatment, adjust psychoeducation to older adults' experiences, and adjust examples in the worksheets to older adults (less work, school and family-oriented examples).
Hence, the timing for testing UP in old adults in a research project seems optimal, with the possibility of collaborating with experienced clinicians and researchers in our project. This research proposal may well provide valuable insights into the feasibility of the Unified Protocol for treating emotional disorders in older adults. The findings will contribute to the growing body of evidence on transdiagnostic treatments and inform the development of adapted interventions for this population. The results will also inform the possibility of conducting a larger RCT with tailored treatment with UP for old adults on a later stage.
- Conditions
- Emotional Disorders
- Being tested
- Unified Protocol
- Keywords
- Emotional disorders, Anxiety, Depression, Avoidant coping, Neuroticism
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified ProtocolBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Unified Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Oct 2024
- Primary completion24 Dec 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Emotional DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NKS Olaviken Gerontopsychiatric Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Kristine G Madsø, Clinical Psychology (PhD), Principal investigator, NKS Olaviken Gerontopsychiatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777693
- Sponsor's protocol ID
- 769706
- Acronym
- UPS
- Status last verified
- Jan 2025
- First submitted
- 30 Sep 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27993336Braun, V., Clarke, V., Hayfield, N., Terry, G. (2019). Thematic analysis. In Handbook of Research Methods in Health Social Sciences (pp. 843-860). Springer.
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.
PubMed 19362699
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Older Adults: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06777693
- Acronym / sponsor ID
- UPS / 769706
- Conditions
- Emotional Disorders
- Keywords
- Emotional disorders, Anxiety, Depression, Avoidant coping, Neuroticism
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- NKS Olaviken Gerontopsychiatric HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Emotional disorders such as anxiety and depression are the most common mental health problems affecting older people, and are highly comorbid . The prevalence is high (greater than 25 %), with increasing prevalence for people with comorbid somatic disorders (greater than 40%). Evidence suggests that psychological treatment for older adults is as effective as for working-age adults and maybe even more effective in old adults with comorbid somatic disorders. Despite this, older adults are generally under-represented in psychological services.
Most older adults with emotional disorders receive psychopharmacological treatment as the first choice, even when national and clinical guidelines suggest offering psychological treatment as a first choice or combining medication and psychological treatment. Studies show that adults older than 65 prefer psychological therapy over psychotropic medication. Choosing psychological treatment also decreases risks associated with polypharmacy. Evidence shows that psychological treatment for common mental health problems in people older than 65 is effective. Implementing effective and available psychological treatment for people older than 65 in Norway is challenging, primarily due to lack of referral to mental health care units despite the guidance of priority for public mental health services recommend stressing the severity of symptoms and not age itself. Negative consequences for untreated mental health problems in older adults can have significant consequences on overall well-being, ranging from social isolation, cognitive decline, increased risk of suicide and exacerbating existing medical conditions. Thus, making evidence-based psychological services available for older adults is a highly relevant goal to achieve.
A key barrier challenging the implementation of evidence-based psychological treatment is that implementing diagnosis-specific protocols is not very well suited to the clinical settings where comorbidity and complexity are the norm. This is not specific for mental health care for people older than 65, implementing evidence-based psychological treatment is challenging in the health care systems in general. Accordingly, transdiagnostic treatment protocols have been developed over the last decades, where the treatment model targets underlying processes and mechanisms across different, but commonly comorbid, diagnoses. Barlow and colleagues have developed the "Unified protocol for transdiagnostic treatment of emotional disorders" in response to this issue. The Unified Protocol (UP) has shown promising results in treating anxiety and depression in various populations. However, its efficacy in older adults (older than 65 years) remains understudied. This is not specific to UP; most treatment protocols and outcome scales used in mental health care for adults are mainly developed for adults of working age and not adapted for the specific issues in late adulthood where immobility and social isolation, comorbid somatic disorders, and impaired executive functioning are more common. Given that psychological treatments for common mental health problems in people older than 65 are effective when adjusted to the needs of the population, investigating the feasibility of transdiagnostic treatments such as UP seems highly relevant. UP's theoretical foundations for development and maintenance of emotional disorders also seems transferable to our specific population, as described in the following section.
The transdiagnostic model of Unified Protocol According to UP, a typical shared personality dimension or temperament of people with emotional disorders is the vulnerability dimension of neuroticism, contributing to experience negative emotions with high intensity. People high in neuroticism tend to perceive these emotions as highly uncontrollable and dangerous, something that should be avoided. In sum, these negative emotions place the person at risk for persistent mental health problems. Two central processes may then contribute to the development of emotional disorders such as anxiety or depression. The first is the tendency to react aversively to intense emotional experiences. The second is the tendency for avoidant coping. UP targets both the vulnerability dimension of neuroticism and the dysfunctional coping of strong emotions. Further, 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-behavioral therapy (CBT), emotion-focused therapy, and mindfulness-based interventions. Patients learn to understand their emotional experiences, observe them without judgment, stop avoidant coping, and change their behaviour toward reaching their goals. Avoiding negative stimuli is a common coping strategy for emotion regulation in old adults, but not all stressors may be avoided. Thus, learning to cope with emotional experiences through exposure as the theoretical foundation of UP suggests, seems transferable to our population. Clinical guidelines on emotional disorders, anxiety and depression in old adults also stress increasing the level of activity and break social isolation as important goals of treatment. Even if neural deterioration will occur with age, there is a potential of neuroplasticity and participants may still learn new behaviours and change in response to new experiences. However, identifying the older patient that will benefit from UP will probably require a wider initial assessment of cognitive functions (memory and executive function) and somatic condition (pharmacological treatment and somatic disorders potentially presenting as psychiatric symptoms).
Objectives UP has been investigated in large trials with promising results. A 14- session Group-based UP is currently implemented, and its feasibility is systematically evaluated in Norway in an adult population (18-40 years). There is an increasing expertise in western Norway on the method. There are also clinical experiences with an eight-session group based UP with older adults from a Geriatric Psychiatric Clinic (Äldrepsykiatrisk mottagning), Sahlgrenska Universitetssjukhuset (Gothenburg, Sweeden) where one found some effect on depressive symptoms and anxiety. Foremost, the participants with the best treatment effect changed the way they related to their thoughts and feelings (their psychological flexibility). As one participant said:" I can recognize my weak spots better. That is a window for change. When I recognize the patterns that are bad for me, it gives me the possibility to change them. I have learned a lot about emotions. I understand so much more, I recognize things that are not helpful to me." Experiences from these groups led the therapists to adapt the original manual and use less worksheets, practice mindful emotion awareness throughout the treatment, adjust psychoeducation to older adults' experiences, and adjust examples in the worksheets to older adults (less work, school and family-oriented examples).
Hence, the timing for testing UP in old adults in a research project seems optimal, with the possibility of collaborating with experienced clinicians and researchers in our project. This research proposal may well provide valuable insights into the feasibility of the Unified Protocol for treating emotional disorders in older adults. The findings will contribute to the growing body of evidence on transdiagnostic treatments and inform the development of adapted interventions for this population. The results will also inform the possibility of conducting a larger RCT with tailored treatment with UP for old adults on a later stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Other | Behavioral: Unified ProtocolThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unified ProtocolThe 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. | Behavioural | Treatment group |
Primary outcome
Qualitative interviews
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Background: PubMed 27993336Barlow 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.
- BackgroundBraun, V., Clarke, V., Hayfield, N., Terry, G. (2019). Thematic analysis. In Handbook of Research Methods in Health Social Sciences (pp. 843-860). Springer.
- Background: PubMed 19362699Bowen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristine G Madsø, Clinical Psychology (PhD) principal investigator
NKS Olaviken Gerontopsychiatric Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol in people with Emotional Disorders, run by NKS Olaviken Gerontopsychiatric Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative interviews (time frame: Immediately after the intervention). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06777693, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.