NCT07771413

Brief 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. Depression levels were assessed before and after the intervention to explore preliminary changes in depressive symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable depression

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2026

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
Last Updated

August 21, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

August 13, 2026

Last Update Submit

August 20, 2026

Conditions

Keywords

depressioncaregiver burdenpilot interventioncerebral palsy

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline to post-intervention (four weeks)

Secondary Outcomes (1)

  • Anxiety

    Baseline to post-intervention (four weeks)

Study Arms (1)

telehealth intervention

EXPERIMENTAL

They took Lewinsohn's Multifactoral Integrative Model of Depression via telephone four weeks

Behavioral: Behavioral Treatment

Interventions

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

telehealth intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gülhane Research and Education Hospital

Ankara, Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DepressionCaregiver BurdenCerebral Palsy

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorStress, PsychologicalBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Tuğçe Kızılakça Soyaslan, Masters

    Gülhane Research and Education Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

August 13, 2026

First Posted

August 18, 2026

Study Start

November 10, 2025

Primary Completion

January 5, 2026

Study Completion

January 20, 2026

Last Updated

August 21, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Begining six months after publication, data will be available for 5 years after publication.
Access Criteria
De-identified individual participant data will be made available upon reasonable request to the corresponding author for scientifically sound research purposes, subject to applicable ethical, privacy, and institutional requirements.

Locations