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

NCT05503485 | Recruiting

• 1 other identifier: 2021-06466
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 7

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. 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. 2.Is experiential avoidance a mediator in the (potential) reduction of psychological distress?
3. 3.Are there any side effects of existential group treatment/supportive telephone calls?
4. 4.Is an existential psychological group treatment for older adults feasible, based on its fidelity?
5. 5.What are older adults' experiences of participating in the existential psychological group treatment/weekly supportive telephone calls?

Conditions

Psychological Distress

Keywords

Existential therapy; Existential group therapy; Existential group treatment; Aging; Old adults; Randomized control trial; Anxiety; Depression; Psychological Distress; Primary care

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Anxiety symptoms

  Pre-intervention, during the intervention (after week 4), immediately after the intervention as well as at a 3-month follow-up

• Depressive symptoms

  Pre-intervention, during the intervention (after week 4), immediately after the intervention as well as at a 3-month follow-up

• Zest for life

  Pre-intervention, during the intervention (after week 4), immediately after the intervention as well as at a 3-month follow-up

• Sleep problems

  Pre-intervention, during the intervention (after week 4), immediately after the intervention as well as at a 3-month follow-up

• Life quality

  Pre-intervention, during the intervention (after week 4), immediately after the intervention as well as at a 3-month follow-up

Other Outcomes (4)

• Working Alliance

  During the intervention (after week 1 and 4) and immediately after the intervention.

• Expectations and credibility of the treatment

  During the intervention (after week 1).

• Side effects

  Immediately after the intervention (week 7).

Study Arms (2)

Existential group treatment

EXPERIMENTAL

Participants who are randomized to the experimental condition will participate in an existential group treatment together with 3 to 6 other participants in seven group sessions of 90-120 minutes each for seven weeks.

Behavioral: Existential group treatment

Supportive telephone calls

ACTIVE COMPARATOR

Participants who are randomized to the control condition will receive brief supportive telephone calls once a week for 7 weeks.

Behavioral: Supportive telephone calls

Interventions

Existential group treatment BEHAVIORAL

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.

Also known as: Slottsskogen Existential Group Treatment

Existential group treatment

Supportive telephone calls BEHAVIORAL

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.

Supportive telephone calls

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Be aged 75+
• Have increased levels of psychological distress (GHQ-12 ≥3)
• Be interested in participating in a research project in which they will receive either group treatment or supportive telephone calls.

You may not qualify if:

• Other ongoing psychological treatment
• 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.
• Inadequate knowledge of Swedish
• Acute suicide risk according to the M.I.N.I.

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator
• Karlstad University: collaborator

Study Sites (7)

Närhälsan Slottsskogen vårdcentral

Gothenburg, 41311, Sweden

RECRUITING

Närhälsan Majorna Vårdcentral

Gothenburg, 41458, Sweden

RECRUITING

Närhälsan Högsbo vårdcentral

Gothenburg, 41480, Sweden

RECRUITING

Vårdcentralen Wästerläkarna

Gothenburg, 426 77, Sweden

RECRUITING

Capio vårdcentral Orust

Henån, 47332, Sweden

RECRUITING

Närhälsan Vårgårda vårdcentral

Vårgårda, 44731, Sweden

NOT YET RECRUITING

Vårdcentralen Kusten Ytterby

Ytterby, 44250, Sweden

RECRUITING

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MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Margda Waern, Professor

  Göteborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isak Erling, Psy M

CONTACT

+46762502060; isak.erling@gu.se

Margda Waern, Professor

CONTACT

margda.waern@neuro.gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: A psychology student will monitor participants self-reported scores for safety reasons.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2022
• First Posted: August 16, 2022
• Study Start: October 11, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (7)