Clinical trial NCT06904976: Nature-Focused Mindfulness and Spiritual Well-being Among Adults with Moderate Prolonged Grief Symptoms
Official title: Nature-Focused Mindfulness and Spiritual Well-being Among Adults with Moderate Prolonged Grief Symptoms: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Grief
Spiritual Wellbeing
Lead sponsor: University of Twente
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this randomized controlled trial is to evaluate whether a nature-focused mindfulness intervention can enhance spiritual well-being and reduce grief symptoms among adults with moderate prolonged grief symptoms. The main questions it aims to answer are:

Does a nature-focused mindfulness intervention improve spiritual well-being compared to an active control condition (noticing nature) and a waitlist control condition?

Does a nature-focused mindfulness intervention reduce grief severity and improve mental well-being, nature connectedness, selflessness, ability to adapt, personal recovery, and elevation compared to control conditions?

How do spiritual well-being, ability to adapt, nature connectedness, selflessness, grief reactions, and positive/negative affect change during the intervention period?

Researchers will compare a nature-focused mindfulness intervention to both a noticing-nature active control group and a waitlist control group to isolate mindfulness-specific effects from possible general nature exposure benefits.

Participants will:

Complete baseline, post-intervention, and follow-up assessments (at one and three months) Engage in either 10 sessions of nature-focused mindfulness practice or noticing nature activities over a two-week period (intervention and active control groups) Provide daily diary responses about their experiences throughout the 14-day intervention period


Eligibility criteria: Inclusion Criteria:

* Be a family member, spouse, or friend of a person who died at least 6 months prior to study enrollment;
* Be ≥18 years of age;
* Report moderate subclinical grief (score range from 47-70) based on the Traumatic Grief Inventory-Self Report Plus (TGI-SR+, Lenferink, Eisma, et al., 2022);
* Have access to a natural environment suitable for the intervention;
* Be willing and able to move in nature daily (with or without mobility assistance devices) and engage in brief mindfulness practices;
* Have sufficient Dutch language proficiency;
* Have access to Internet and mobile applications.

Exclusion Criteria:

* Acute suicide risk assessed in the screening step;
* A score lower than 47 or higher than 70 on TGI-SR+;
* Physical limitations that prevent moving outdoors for 30 minutes daily, even with mobility assistance devices.

Primary outcomes:
measure: Spiritual well-being measured by Spiritual Attitude and Involvement List-Short Form
timeFrame: Baseline
measure: Spiritual well-being measured by Spiritual Attitude and Involvement List-Short Form
timeFrame: 1 month after baseline
measure: Spiritual well-being measured by Spiritual Attitude and Involvement List-Short Form
timeFrame: 2 months after baseline
measure: Spiritual well-being measured by Spiritual Attitude and Involvement List-Short Form
timeFrame: 4 months after baseline
Secondary outcomes:
measure: Grief intensity measured by Traumatic Grief Inventory-Self Report Plus
timeFrame: Baseline
measure: Grief intensity measured by Traumatic Grief Inventory-Self Report Plus
timeFrame: 1 month after baseline
measure: Grief intensity measured by Traumatic Grief Inventory-Self Report Plus
timeFrame: 2 months after baseline
measure: Grief intensity measured by Traumatic Grief Inventory-Self Report Plus
timeFrame: 4 months after baseline
measure: Nature connectedness measured by Inclusion of Nature in Self scale
timeFrame: Baseline
measure: Nature connectedness measured by Inclusion of Nature in Self scale
timeFrame: 1 month after baseline
measure: Nature connectedness measured by Inclusion of Nature in Self scale
timeFrame: 2 months after baseline
measure: Nature connectedness measured by Inclusion of Nature in Self scale
timeFrame: 4 months after baseline
measure: Nature connectedness measured by Connectedness to Nature Scale
timeFrame: Baseline
measure: Nature connectedness measured by Connectedness to Nature Scale
timeFrame: 1 month after baseline
measure: Nature connectedness measured by Connectedness to Nature Scale
timeFrame: 2 months after baseline
measure: Nature connectedness measured by Connectedness to Nature Scale
timeFrame: 4 months after baseline
measure: Mental well-being measured by Mental Health Continuum-Short Form
timeFrame: Baseline
measure: Mental well-being measured by Mental Health Continuum-Short Form
timeFrame: 1 month after baseline
measure: Mental well-being measured by Mental Health Continuum-Short Form
timeFrame: 2 months after baseline
measure: Mental well-being measured by Mental Health Continuum-Short Form
timeFrame: 4 months after baseline
measure: Selflessness measured by Perceived Body Boundaries Scale
timeFrame: Baseline
measure: Selflessness measured by Perceived Body Boundaries Scale
timeFrame: 1 month after baseline
measure: Selflessness measured by Perceived Body Boundaries Scale
timeFrame: 2 months after baseline
measure: Selflessness measured by Perceived Body Boundaries Scale
timeFrame: 4 months after baseline
measure: Selflessness measured by Spatial Frame of Reference Continuum
timeFrame: Baseline
measure: Selflessness (Spatial Frame of Reference Continuum)
timeFrame: 1 month after baseline
measure: Selflessness measured by Spatial Frame of Reference Continuum
timeFrame: 2 months after baseline
measure: Selflessness measured by Spatial Frame of Reference Continuum
timeFrame: 4 months after baseline
measure: Elevation measured by Elevating Experiences Scale
timeFrame: Baseline
measure: Elevation measured by Elevating Experiences Scale
timeFrame: 1 month after baseline
measure: Elevation measured by Elevating Experiences Scale
timeFrame: 2 months after baseline
measure: Elevation measured by Elevating Experiences Scale
timeFrame: 4 months after baseline
measure: Ability to adapt measured by Generic Sense of Ability to Adapt Scale
timeFrame: Baseline
measure: Ability to adapt measured by Generic Sense of Ability to Adapt Scale
timeFrame: 1 month after baseline
measure: Ability to adapt measured by Generic Sense of Ability to Adapt Scale
timeFrame: 2 months after baseline
measure: Ability to adapt measured by Generic Sense of Ability to Adapt Scale
timeFrame: 4 months after baseline
measure: Personal recovery measured by Brief INSPIRE-O
timeFrame: Baseline
measure: Personal recovery measured by Brief INSPIRE-O
timeFrame: 1 month after baseline
measure: Personal recovery measured by Brief INSPIRE-O
timeFrame: 2 months after baseline
measure: Personal recovery measured by Brief INSPIRE-O
timeFrame: 4 months after baseline
measure: Daily diary (assessed daily during 14-day intervention period)
timeFrame: From baseline to post-intervention (2-weeks)
Other outcomes:
measure: Demographic characteristics
timeFrame: Baseline
measure: Loss-related characteristics
timeFrame: Baseline
measure: Previous mindfulness experience
timeFrame: Baseline
measure: Previous Nature experience
timeFrame: Baseline
measure: Intervention adherence
timeFrame: 1 month after baseline
measure: Co-intervention use
timeFrame: 1 month after baseline
measure: Client satisfaction measured by Client Satisfaction Questionnaire
timeFrame: 1 month after baseline
Locations:
Study officials:
References: