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Completed

NCT Number: NCT07771413

Effect of a Telehealth Intervention on Depressive Symptoms Among Caregivers of Patients With Cerebral Palsy Receiving Home Care

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Brain Damage, Chronic Brain Diseases Caregiver Burden Central Nervous System Diseases Cerebral Palsy Nervous System Diseases Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gülhane Research and Education Hospital

Ankara, 06000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • have a child who diagnosed cerebral palsy
  • have adequate cognitive ability
  • 18 years or older
  • BDI score ≥3

Exclusion criteria

  • under 18 years old
  • BDI score <3
  • cognitive impairment
  • not being a caregiver of cerebral palsy

Treatment and study plan

Behavioral Treatment

Behavioral

Caregiver's took behavioral intervention model via telephone every four week, same day at same hour

Primary outcomes

  1. Depression

    Time frame: Baseline to post-intervention (four weeks)

    BDI-I

Secondary outcomes

  1. Anxiety level

    Time frame: Baseline to post-intervention (four weeks)

    Beck Anxiety Scale

Sponsors and collaborators

Lead sponsor

Gülhane Research and Education Hospital

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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