Schizophenia DisorderNCT07131137
A Remote Life Balance Training Program for People With Schizophrenia
A study testing The Life Balance Training Intervention in people with Schizophenia Disorder, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophenia Disorder
- What is being tested?
- The Life Balance Training Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a clinical diagnosis of schizophrenia according to DSM-5 criteria,
- access to an Internet-enabled electronic communication device,
- a stable Internet connection.
Who cannot join
- significant communication difficulties,
- comorbid chronic neurological or psychiatric conditions,
- inability to access communication materials and the Internet.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Design and Structure of a Remote Life Balance Training Program for People With Schizophrenia
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.
- Conditions
- Schizophenia Disorder
- Being tested
- The Life Balance Training Intervention
- Keywords
- schizophrenia, telerehabilitation, life balance, remote care, intervention protocol
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Life Balance Training InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: The Life Balance Training Intervention |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 .
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Feb 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophenia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131137
- Sponsor's protocol ID
- AtlasU
- Status last verified
- Aug 2025
- First submitted
- 10 Jul 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Structure of a Remote Life Balance Training Program for People With Schizophrenia
- ClinicalTrials.gov ID
- NCT07131137
- Acronym / sponsor ID
- AtlasU
- Conditions
- Schizophenia Disorder
- Keywords
- schizophrenia, telerehabilitation, life balance, remote care, intervention protocol
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: The Life Balance Training Intervention |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a clinical diagnosis of schizophrenia according to DSM-5 criteria,
- access to an Internet-enabled electronic communication device,
- a stable Internet connection.
Key exclusion criteria (3 listed)
- significant communication difficulties,
- comorbid chronic neurological or psychiatric conditions,
- inability to access communication materials and the Internet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Life Balance Training InterventionThe 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. | Behavioural | Intervention group |
Primary outcome
Life Balance
Time frame: 8 weeks
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)
Instrumental Activities of Daily Living
Time frame: 8 weeks
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 .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Life Balance Training Intervention in people with Schizophenia Disorder, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life Balance (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.