NCT07131137

Brief Summary

People living with schizophrenia often experience significant disruptions to their ability to maintain a balanced lifestyle and perform daily activities. These disruptions can hinder their ability to participate successfully in community life. In response to these challenges, a pilot study was planned to examine the feasibility and effectiveness of a telerehabilitation-based occupational therapy program aimed at promoting life balance and functional skills. The eight-week intervention is delivered remotely via videoconferencing and incorporates personalized goal setting, activity planning, skills training, and problem-solving strategies tailored to each participant. Clients diagnosed with schizophrenia who could engage in virtual sessions were invited to voluntarily participate, and pre- and post-intervention assessments were planned to measure outcomes related to instrumental activities of daily living and perceived life balance. This study aims to generate preliminary data on whether a remote, therapist-guided approach can positively impact daily functioning and quality of life. This information will guide the development of larger-scale trials in the future.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

July 10, 2025

Last Update Submit

August 12, 2025

Conditions

Keywords

schizophreniatelerehabilitationlife balanceremote careintervention protocol

Outcome Measures

Primary Outcomes (2)

  • Life Balance

    Life Balance Inventory (LBI): The LBI is a self-report instrument that evaluates the congruence between the time an individual spends on 53 daily activities and the time they would prefer to spend. The assessment is comprised of two steps. First, individuals indicate whether they engage in each activity. Second, they rate their satisfaction with time spent over the past month on a 3-point scale ranging from 1 (very unbalanced) to 3 (very balanced). The LBI score, ranging from 1.00 to 3.00, is a quantitative metric that quantifies life balance. Higher scores indicate higher levels of life balance. Furthermore, four subscale scores are derived from 51 items: The scale comprises six items in the domain of health, 20 items in the domain of challenge/interest, 15 items in the domain of identity, and 10 items in the domain of relationships. The LBI demonstrates excellent internal consistency in the general population (Cronbach's α = 0.97)

    8 weeks

  • Instrumental Activities of Daily Living

    Lawton-Brody Instrumental Activities of Daily Living Scale (IADL): The Lawton-Brody IADL Scale is a widely used observational tool developed to assess an individual's functional competence in performing eight instrumental activities necessary for independent living. These activities include the use of the telephone, shopping, food preparation, housekeeping, laundry, transportation, medication management, and financial management. Each item is evaluated using a 3-point scale, with 1 indicating "cannot perform," 2 indicating "needs assistance," and 3 indicating "independent." The total score ranges from 8 to 24. Scores on this scale range from 8 to 24, with higher scores indicating greater independence. The scale is commonly used to make classifications, with scores of 8-10 indicating dependence, 11-16 indicating semi-dependence, and 17-24 indicating independence. The original version exhibited adequate internal consistency, as evidenced by a Cronbach's alpha of 0.85 .

    8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL
Behavioral: The Life Balance Training Intervention

Control group

NO INTERVENTION

Interventions

The Life Balance Training intervention is administering as an individualized, therapist-guided program over a period of eight weeks, comprising two 45-minute sessions per week conducted via videoconferencing platforms. The program's objective was to enhance engagement in meaningful daily activities, promote a sense of life balance, and improve participation in instrumental activities of daily living (IADLs). Each session focused on fundamental components, including goal setting, skills training, activity planning, and problem solving. Caregiver involvement is encouraging when appropriate to support the generalization of skills to the home environment. The sessions commenced with a collaborative goal-setting process, centred on participants' desired modifications to their daily routines and occupational balance. The curriculum encompassed a range of pertinent subjects, including meal preparation, financial management, and time management.

Intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a clinical diagnosis of schizophrenia according to DSM-5 criteria,
  • access to an Internet-enabled electronic communication device,
  • a stable Internet connection.

You may not qualify if:

  • significant communication difficulties,
  • comorbid chronic neurological or psychiatric conditions,
  • inability to access communication materials and the Internet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community-based psychiatric services

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2025

First Posted

August 20, 2025

Study Start

February 1, 2025

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

August 20, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations