NCT05503485 Existential Group Treatment for Older Adults (75+) With Psychological Distress in Primary Care
| NCT ID | NCT05503485 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Göteborg University |
| Condition | Psychological Distress |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2022-10-11 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2022-10-11 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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?
Eligibility Criteria
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.
Contact & Investigator
Margda Waern, Professor
PRINCIPAL INVESTIGATOR
Göteborg University
Frequently Asked Questions
Who can join the NCT05503485 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Psychological Distress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05503485 currently recruiting?
Yes, NCT05503485 is actively recruiting participants. Contact the research team at isak.erling@gu.se for enrollment information.
Where is the NCT05503485 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Gothenburg, Sweden, Gothenburg, Sweden, Gothenburg, Sweden and 3 additional locations.
Who is sponsoring the NCT05503485 clinical trial?
NCT05503485 is sponsored by Göteborg University. The principal investigator is Margda Waern, Professor at Göteborg University. The trial plans to enroll 140 participants.