DepressionNCT07771413
Effect of a Telehealth Intervention on Depressive Symptoms Among Caregivers of Patients With Cerebral Palsy Receiving Home Care
A study testing Behavioral Treatment in people with Depression, run by Gülhane Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this pilot intervention study is to assess the feasibility of applying Lewinsohn's Multifactoral Integrative Model of Depression to caregivers of patients with cerebral palsy. Caregivers received a four-week telehealth intervention based on the model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Behavioral Treatment
- 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
- 10 Nov 2025to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a child who diagnosed cerebral palsy
- have adequate cognitive ability
- 18 years or older
- BDI score ≥3
Who cannot join
- under 18 years old
- BDI score <3
- cognitive impairment
- not being a caregiver of cerebral palsy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gülhane Research and Education Hospital
Ankara, Ankara, 06000
About this study
The aim of this pilot intervention study is to assess the feasibility of applying Lewinsohn's Multifactoral Integrative Model of Depression to caregivers of patients with cerebral palsy. Caregivers received a four-week telehealth intervention based on the model. Depression levels were assessed before and after the intervention to explore preliminary changes in depressive symptoms.
Read the detailed description
This pilot intervention study evaluated the feasibility of a four-week telehealth intervention based on Lewinsohn's Multifactoral Integrative Model of Depression among caregivers of patients with cerebral palsy receiving home healthcare services. The intervention was designed to address factors associated with depressive symptoms within the framework of the model and was delivered over four weeks through four planned sessions.
Caregivers who met the eligibility criteria participated in the intervention. Depression and anxiety symptoms were assessed before and after the intervention using validated self-report measures.
The study primarily aimed to evaluate the feasibility of the intervention and to obtain preliminary estimates of changes in depressive symptoms that could inform the design of a future controlled trial. Because this was a pilot study with a single intervention group and a small sample, the findings are intended to provide preliminary evidence regarding the feasibility of the intervention and to inform the design of a future controlled study.
- Conditions
- Depression
- Being tested
- Behavioral Treatment
- Keywords
- depression, caregiver burden, pilot intervention, cerebral palsy
- Medical subject headings
- Depression, Caregiver Burden, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral TreatmentBehavioural
Caregiver's took behavioral intervention model via telephone every four week, same day at same hour
| Study group | Role | What they receive |
|---|---|---|
| telehealth intervention | Experimental | They took Lewinsohn's Multifactoral Integrative Model of Depression via telephone four weeks Receives: Behavioral: Behavioral Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Beck Depression Inventory-I was used in this study. People fill out this inventory with reviewing their last week and scores summed up for total scores. Results were meant 0-9=minimal depression, 10-16=mild, 17-29= moderate, 30-63= severe depression
Measured: Baseline to post-intervention (four weeks)
Secondary outcomes (1)
Anxiety
Beck Anxiety Inventory was used in this study for evaluate the frequency of individuals' symptoms of anxiety for adults.It is a self-report inventory and has twenty-one questions and third-degree Likert scale.
Measured: Baseline to post-intervention (four weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start10 Nov 2025
- Primary completion5 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gülhane Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tuğçe Kızılakça Soyaslan, Gülhane Research and Education Hospital
- Investigators
- Tuğçe Kızılakça Soyaslan, Masters, Principal investigator, Gülhane Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771413
- Sponsor's protocol ID
- GUREH-CG-2025-369
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the reported results will be shared, including demographic characteristics, baseline and post-intervention depression and anxiety scores, caregiver burden scores, and relevant clinical and caregiving characteristics.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Telehealth Intervention on Depressive Symptoms Among Caregivers of Patients With Cerebral Palsy Receiving Home Care
- ClinicalTrials.gov ID
- NCT07771413
- Acronym / sponsor ID
- GUREH-CG-2025-369
- Conditions
- Depression
- Keywords
- depression, caregiver burden, pilot intervention, cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Gülhane Research and Education HospitalOther government
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 18 Aug 2026 (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.
The aim of this pilot intervention study is to assess the feasibility of applying Lewinsohn's Multifactoral Integrative Model of Depression to caregivers of patients with cerebral palsy. Caregivers received a four-week telehealth intervention based on the model. Depression levels were assessed before and after the intervention to explore preliminary changes in depressive symptoms.
Detailed description
This pilot intervention study evaluated the feasibility of a four-week telehealth intervention based on Lewinsohn's Multifactoral Integrative Model of Depression among caregivers of patients with cerebral palsy receiving home healthcare services. The intervention was designed to address factors associated with depressive symptoms within the framework of the model and was delivered over four weeks through four planned sessions.
Caregivers who met the eligibility criteria participated in the intervention. Depression and anxiety symptoms were assessed before and after the intervention using validated self-report measures.
The study primarily aimed to evaluate the feasibility of the intervention and to obtain preliminary estimates of changes in depressive symptoms that could inform the design of a future controlled trial. Because this was a pilot study with a single intervention group and a small sample, the findings are intended to provide preliminary evidence regarding the feasibility of the intervention and to inform the design of a future controlled study.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| telehealth intervention | Experimental | Behavioral: Behavioral TreatmentThey took Lewinsohn's Multifactoral Integrative Model of Depression via telephone four weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- have a child who diagnosed cerebral palsy
- have adequate cognitive ability
- 18 years or older
- BDI score ≥3
Key exclusion criteria (4 listed)
- under 18 years old
- BDI score <3
- cognitive impairment
- not being a caregiver of cerebral palsy
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 |
|---|---|---|
| Behavioral TreatmentCaregiver's took behavioral intervention model via telephone every four week, same day at same hour | Behavioural | telehealth intervention |
Primary outcome
Depression
Time frame: Baseline to post-intervention (four weeks)
Beck Depression Inventory-I was used in this study. People fill out this inventory with reviewing their last week and scores summed up for total scores. Results were meant 0-9=minimal depression, 10-16=mild, 17-29= moderate, 30-63= severe depression
1 secondary outcome
Anxiety
Time frame: Baseline to post-intervention (four weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the reported results will be shared, including demographic characteristics, baseline and post-intervention depression and anxiety scores, caregiver burden scores, and relevant clinical and caregiving characteristics.
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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. This study is not recruiting at the moment.
Tuğçe Kızılakça Soyaslan, Masters principal investigator
Gülhane Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Treatment in people with Depression, run by Gülhane Research and Education Hospital 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 21 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depression (time frame: Baseline to post-intervention (four weeks)). 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 21 Aug 2026.