Existential Group Treatment for Older Adults (75+) With Psychological Distress in Primary Care

Psychological Distress Clinical Trial

Official title:

Existential Group Treatment for Older Adults (75+) With Psychological Distress in Primary Care: A Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05503485
• Other study ID #: 2021-06466
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: December 2026

Study information

• Verified date: April 2023
• Source: Göteborg University
• Contact: Isak Erling, Psy M
• Phone: +46762502060
• Email: isak.erling[@]gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Symptoms of depression and anxiety are common in older adults, and high suicide rates are observed in this age group in Sweden, as in many countries around the globe. Ageing is accompanied by an increased risk of pain, grief, loss, loneliness, cognitive decline and reduced functional ability, all of which may impact on mental health. Despite these facts, older adults are less likely than their younger counterparts to receive care for their mental health problems.

Within primary care, many older adults with symptoms of depression and anxiety do not fully meet diagnostic criteria for clinical diagnosis. However, these subthreshold states, often conceptualized as "psychological distress" are associated with emotional suffering, reduced quality of life and compromised function in daily life. Psychological distress, which is mainly treated in primary care, has been shown to increase after the age of 65, and to peak at ages 80-89. This points to a need for effective interventions for older adults in primary care to reduce the risk of developing clinical depression and anxiety disorders.

The overall aim of this clinical study is to evaluate, using a randomized control trial design (RCT), an existential psychological group treatment for older adults (75+) with psychological distress in a primary care setting. Research persons randomized to the control arm will receive supportive telephone calls.

Specific research aims include:

1. Do older adults show a) decreased psychological distress, b) decreased experiential avoidance, as well as c) improved quality of life after taking part in existential psychological group treatment? Do those randomized to group treatment have significantly better outcomes compared to those randomized to weekly supportive telephone calls? If so, are the positive effects maintained over time?

2. Is experiential avoidance a mediator in the (potential) reduction of psychological distress?

3. Are there any side effects of existential group treatment/supportive telephone calls?

4. Is an existential psychological group treatment for older adults feasible, based on its fidelity?

5. What are older adults' experiences of participating in the existential psychological group treatment/weekly supportive telephone calls?

Description:

In Sweden, psychotherapy is recommended for adults with mild to moderate severity of depression and anxiety. However, studies that target the effectiveness of psychotherapies in older adults are insufficient and seldom conducted according to protocols that take gerontological evidence into account, rendering them less age-appropriate.

The investigators in this research group, recently carried out a focus group study with older adults who had pharmacological treatment for depression. A clear message was that the participants wished for a dialog with their professional caregivers about existential issues. They wanted to talk about thoughts about aging and death. Participants saw death not only as a threat, but also as a potential source of escape from mental pain. The latter echoes our results from our mixed methods study on older adults' reasons for attempting suicide, highlighting the need for older patients with mental health issues to have opportunities for a deeper dialogue with professional caregivers about the existential concerns they experience in daily life as they age.

Existential problems of life such as loneliness and coping with the approach of death and parting have been proposed as central challenges in old age. Interest in these issues is growing, and further catalyzed by the covid-19-pandemic. Existential concerns such as death anxiety and loneliness have been linked to a wide variety of mental health problems and existential therapy is now considered a potential candidate for addressing these problems in a systematic manner. Existential therapy is an established therapy form with roots in the humanistic school of psychology that developed during the 1960's. The therapy aims at helping clients to address and handle existential issues such as meaning, loneliness and death anxiety. Four main schools of existential therapies have been identified, all sharing the main assumption that human life is characterized by inevitable limitations and challenges, and that avoidance and denial of these existential concerns may hinder personal development and contribute to psychopathology. Central themes of human existence commonly addressed in existential therapies including meaning, fear of death and loneliness have recently been linked to subjective wellbeing and psychopathology contributing to a growing interest in existential therapy from therapists practicing other therapy forms such as cognitive-behavioral therapy. Attempts have been made to understand existential concerns in a cognitive-behavioral context.

A meta-analysis on the effect of existential therapy in various patient populations, as well as a quantitative report from primary care both show promising results. However, while existential therapy could be of particular relevance for problems related to aging, the investigators in this research group are aware of no published study in which existential therapy has been adapted specifically for older adult patients with psychological distress. Primary care would be the appropriate setting for such an endeavor.

Design. This is a randomized controlled study in which participants are randomly assigned to a psychological group treatment (7 weeks), or to the control condition (a brief supportive check-in once a week during 7 weeks with a psychology student trained in telephone support). Participants will be block randomized by an independent statistician. The proposed study will follow the CONSORT guidelines. Participants who are randomly assigned to the telephone control group will complete the same evaluations as those participating in the intervention, and at the same points. This design enables us to exclude several alternative explanations, such as time and history, and thus increasing the internal validity of the trial, i.e., the certainty that (potential) effects are the result of the existential group intervention. Since there is little evidence regarding existential group interventions for older adults, using this kind of control group is a first step. A minimum requirement for analyzing mediation (the potential role of experiential avoidance) is a midway measurement.

Therapist training will include study of the treatment manual and simulated training sessions. The following should ensure good implementation of the intervention: 1) treatment manuals with checklists and 2) audio recordings of the group sessions and an evaluation of 25% of these recordings (randomly selected) by an independent evaluator to study the construct validity of the intervention, i.e., whether participants really receive all components included in the intervention.

Recruitment. Older adults (age ≥ 75) with perceived psychological distress residing in the Västra Götalandsregionen are recruited via participating primary care centers.

Screening. Prospective participants will undergo a brief screening comprising a self-report questionnaire on perceived psychological distress, the General Health Questionnaire 12 (GHQ-12). Those with increased levels of psychological distress (GHQ-12 ≥3) will take part in a diagnostic interview with a mental health professional, the Mini-International Neuropsychiatric Interview (M.I.N.I., Diagnostic and Statistical Manual 5 version) and complete a measurement of global cognitive performance (MMSE). The screening can take place at the patient's primary care center or in the home if that is the wish of the potential participant.

Statistical analyses. The investigators will use an intention-to-treat analysis. The data will be analyzed using growth curve models (either with mixed or structural equation modelling) with the aim of examining individual differences and change in variables during and after treatment as well as during the follow-up.Two types of effect measures are of interest. One is the group by time interaction (ie from the pre-intervention measurement to the final measurement, and potentially also the trend deviation between the last session and the 3-month follow-up). The second effect measure is the post-treatment differences between study arms at a) the last session and b) the 3-month follow-up. In combination these should provide a comprehensive evaluation of the (potential) effect of the existential group treatment. If the group treatment has any effect, the investigators will want to examine whether this effect is "driven" by the intervention (interaction effect). The statistical approach is based on regression analyses. Contrary to more traditional variable-oriented analyses for repeated measurements, it has the benefit of better handling missing data, and unbalanced study design, by incorporating all available information. This last method is now regarded as preferable to using more traditional methods for missing data in clinical data. The potential mediator (experiential avoidance) will be examined through different types of regression analyses. To investigate a process such as mediation, at least three points of measurement are needed, and to control for the initial levels of the examined variables.

Power. The investigators in this research group have calculated the number of participants needed, based on earlier studies. Some of these studies showed large effects. However, they involve individual rather than group treatment, and they did not specifically involve older adults, making the results of the meta-analysis less applicable to the current study. Therefore, the investigators choose to calculate power based on a medium effect size. Hence, given a desired power of 0.80 (a 4/5 chance of discovering an effect if it exists, regarded as adequate in this context), a risk level of 5% as well as an effect size of 0.50, 128 participants are needed. Based on participation in the clinical improvement project at Slottsskogen Primary Care Center during 2018-19, the investigators expect a dropout rate of 10%, and thus add another 12 participants (total N=140).

Qualitative analyses of focus group data. The investigators will use focus group interviews to examine older adults' experience of participating in the intervention, with separate focus groups for those with group treatment/telephone support. Focus groups are mainly based on the dynamics that arise in the conversation between group members, which means that the interviewer initiates the topic of the conversation but has a less active role than in individual interviews. There will also be a monitor at each interview to ensure that study topics are covered in accordance with the focus group guide and that all get a chance to participate. The investigators anticipate 8 groups (4 groups per study arm) with a purposive sample of 4-5 participants/group. The focus group interviews will be audio recorded and professionally transcribed. Transcriptions will be analyzed using thematic analysis according to Braun and Clarke. Thematic analysis is about exploring the data material with a focus on recurring meanings, which then form themes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

1. Be aged 75+

2. Have increased levels of psychological distress (GHQ-12 =3)

3. Be interested in participating in a research project in which they will receive either group treatment or supportive telephone calls.

Exclusion Criteria:

1. Other ongoing psychological treatment

2. Indications that the group format will be unsuitable due to conditions such as clinical diagnosis of dementia or MMSE =25, ongoing severe alcohol use disorder, ongoing post- traumatic stress disorder, ongoing psychotic or manic episodes, or other mental health problems necessitating the offering of other specified treatment, as identified by the M.I.N.I.

3. Inadequate knowledge of Swedish

4. Acute suicide risk according to the M.I.N.I.

Related Conditions & MeSH terms

• Psychological Distress

Intervention

Behavioral:
• Existential group treatment
The existential group treatment follows a manualised structure focusing on aging-related challenges related to existential themes such as story of life, freedom, loneliness, and death. In order to support patients in finding new, productive ways of engaging in the existential process of aging literary texts, therapy practices and assignments between the sessions are used and each group will be accompanied by two therapists who facilitate the group climate, gently bring the group back on topic and help group members to see different ways of dealing with existential concerns related to aging.
• Supportive telephone calls
The supportive caller will provide empathetic basic support, equivalent to the telephone support provided within the Swedish non-governmental organization Mind's "Äldrelinjen". No psychotherapeutic techniques will be applied and there will be no interventions beyond the phone call itself.

Locations

Country	Name	City	State
Sweden	Närhälsan Högsbo vårdcentral	Göteborg
Sweden	Närhälsan Majorna Vårdcentral	Göteborg
Sweden	Närhälsan Slottsskogen vårdcentral	Göteborg
Sweden	Vårdcentralen Wästerläkarna	Göteborg
Sweden	Capio vårdcentral Orust	Henån
Sweden	Närhälsan Vårgårda vårdcentral	Vårgårda
Sweden	Vårdcentralen Kusten Ytterby	Ytterby

Sponsors (3)

Lead Sponsor	Collaborator
Göteborg University	Karlstad University, Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Working Alliance	Measured by the Working Alliance Inventory Short Revised (WAI-SR)	During the intervention (after week 1 and 4) and immediately after the intervention.
Other	Expectations and credibility of the treatment	Measured by the Credibility and Expectancy Questionnaire (CEQ)	During the intervention (after week 1).
Other	Side effects	Measured by the Negative Effects Questionnaire (NEQ)	Immediately after the intervention (after week 7).
Other	Group climate	Measured by questions added to WAI-SR from Robak, R.W., et al. (2013) for participants in the experimental condition.	Immediately after the intervention (after week 7).
Primary	Change in Psychological Distress	Measured by General Health Questionnaire (GHQ-12)	Pre-intervention, during the intervention (after week 4), immediately after the intervention as well as at a 3-month follow-up
Primary	Change in Experiential avoidance	Measured by the Brief Experiential Avoidance Questionnaire (BEAQ)	Pre-intervention, during the intervention (after week 4), immediately after the intervention as well as at a 3-month follow-up
Secondary	Anxiety symptoms	Measured by the Hospital Anxiety and Depression Scale (HADS)	Pre-intervention, during the intervention (after week 4), immediately after the intervention as well as at a 3-month follow-up
Secondary	Depressive symptoms	Measured by the Hospital Anxiety and Depression Scale (HADS)	Pre-intervention, during the intervention (after week 4), immediately after the intervention as well as at a 3-month follow-up
Secondary	Zest for life	Measured by the Montgomery-Åsberg Depression Rating Scale-Self report item 9 (MADRS)	Pre-intervention, during the intervention (after week 4), immediately after the intervention as well as at a 3-month follow-up
Secondary	Sleep problems	Measured by the Insomnia Severity Index (ISI)	Pre-intervention, during the intervention (after week 4), immediately after the intervention as well as at a 3-month follow-up
Secondary	Life quality	Measured by the Brief Quality of Life Scale (BBQ)	Pre-intervention, during the intervention (after week 4), immediately after the intervention as well as at a 3-month follow-up