跳至主要内容
临床试验/NCT05503485
NCT05503485招募中不适用

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

Göteborg University14 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
140
试验地点
14
主要终点
Change in Psychological Distress

研究概览

简要总结

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?

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

A psychology student will monitor participants self-reported scores for safety reasons.

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change in Psychological Distress

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

Measured by General Health Questionnaire (GHQ-12)

Change in Experiential avoidance

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

Measured by the Brief Experiential Avoidance Questionnaire (BEAQ)

次要结局

  • Anxiety symptoms(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)
  • Depressive symptoms(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)
  • Zest for life(Pre-intervention, during the intervention (after week 4), immediately after the intervention as well as at a 3-month follow-up)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (14)

Loading locations...

相似试验