NCT06419881

Brief Summary

Older adults with constricted life-space mobility face increased risk of social isolation and poor mental health. Despite the benefits of therapeutic interventions, the literature indicates low use of mental health services in the older population, often due to mobility limitations and/or negative attitudes toward psychotherapy. Developing accessible interventions that address negative attitudes towards mental health services is crucial. Group drama therapy has shown to improve the mental health of older adults, and the creative process itself may help overcome stigmas associated with seeking mental health services. The aim of this study was to explore a 12-week tele-drama therapy group intervention tailored for older adults with constricted mobility. The intervention integrated playback theatre and life review therapy, and was delivered via Uniper Care, an accessible technology designed for older adults. The study will explore the contribution of the intervention and will examine the relationship between processes in drama therapy and their contribution on older adults mental health. This study will also explore the experience of participants, therapists and staff members.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

May 9, 2024

Last Update Submit

May 14, 2024

Conditions

Keywords

Life Space MobilityTele-drama therapy interventionOlder AdultsMental healthSocial Connectedness

Outcome Measures

Primary Outcomes (6)

  • Social Connectedness

    Social connectedness was measured using a composite score of two measures: The 10-item satisfaction in social relationships subscale from the UCLA loneliness scale (Russell et al., 1980), and the 9-item positive relationships with others subscale of the psychological well-being scale (Ryff, 1991); both measures were rated on a 5-point scale.

    (1) Baseline, (2) Post intervention

  • Psychological well-being

    Psychological well-being was measured using two subscales from the Ryff scale (1991): self-acceptance and personal developement , which were rated from 1 (Strongly disagree) to 5 (Strongly agree).

    (1) Baseline, (2) up to 1 week post intervention

  • Meaning in life

    Meaning in life was measured using an abridged 8-items version (Krause, 2007), adapted for older adults. Items were rated from 1 (Strongly disagree) to 5 (Strongly agree).

    (1) Baseline, (2) up to 1 week post intervention

  • Well-being

    Well-being was measured using the 5-item WHO-5 scale (Gosling et al., 2003; Keisari et al., 2022). Items were rated from 0 (Never) to 5 (All the time).

    (1) Baseline, (2) up to 1 week post intervention

  • Loneliness

    Loneliness was measured using the 10-item dissatisfaction in social relationships subscale from the UCLA loneliness scale (Russell et al., 1980), with an additional item ("I feel lonely"). Items were rated from 1 (Never) to 5 (Always).

    (1) Baseline, (2) up to 1 week post intervention

  • Depressive symptoms

    Depressive symptoms were measured using the Geriatric Depression Scale (Yesavage et al., 1982), a questionnaire composed of 15 yes/no questions that relate to how participants felt in the previous week.

    (1) Baseline, (2) up to 1 week post intervention

Secondary Outcomes (7)

  • Therapeutic alliance

    up to 1 week after session No. 10

  • Meaningfulness in drama therapy

    up to 1 week after session No. 10

  • Vitality

    up to 1 week after session No. 10

  • Subjective social support

    up to 1 week after session No. 10

  • Flow

    up to 1 week after session No. 10

  • +2 more secondary outcomes

Study Arms (2)

Tele-drama therapy intervention

EXPERIMENTAL

This arm received a 12-week tele-drama therapy intervention, with each session lasting 75 minutes via the Uniper Care platform.

Behavioral: Tele-drama therapy

Usual Care

OTHER

This usual care arm continued to receive routine activities provided by Uniper Care.

Other: Usual Care

Interventions

A 12-week tele-drama therapy group intervention integrating Playback Theater and Life Review Therapy

Tele-drama therapy intervention

This arm continued to receive the routine activities provided by Uniper Care

Usual Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • age 65 and over with constricted life space mobility
  • with normal cognitive functioning (assessed by the research coordinator and community coordinators at Uniper Care)
  • selected by the research coordinator and community coordinators as suitable to participate in a treatment group
  • with sufficient mastery of the Hebrew language
  • with an absence of a diagnosis of a mental disorder
  • who expressed interest in taking part in a drama therapy intervention and provided informed consent.

You may not qualify if:

  • older adults who experienced the loss of a souse or child six months prior to the intervention
  • participants in the experimental group who missed four or more of the 12 sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniper Care

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Shoshi Keisari, PhD

    University of Haifa

    PRINCIPAL INVESTIGATOR
  • Hod Orkibi, PhD

    University of Haifa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to eight tele-drama therapy treatment groups or eight usual care groups. Participants in the experiment group received a 12-week tele-drama therapy intervention, with each session lasting 75 minutes via the Uniper Care platform. Participants in the usual care groups continued to receive the routine activities provided by Uniper Care. As a token of gratitude for their participation, participants in the control groups were offered a 3-session online playback theater workshop, in addition to a gift card.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2024

First Posted

May 17, 2024

Study Start

March 3, 2022

Primary Completion

October 30, 2022

Study Completion

January 29, 2023

Last Updated

May 17, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Upon Request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
One year after publication
Access Criteria
Upon Request

Locations