Trial Title:
Online or In-person Interventions on Anxiety and Depression Symptoms in Caregivers of Patients with Cancer
NCT ID:
NCT06592573
Condition:
Anxiety
Depressive Symptoms
Conditions: Official terms:
Depression
Anxiety Disorders
Conditions: Keywords:
Online Psychotherapy
Cargivers
Cancer
Grief
Cognitive-Behavioural Therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
CBT_ONLINE
Description:
10-12 sessions of cognitive behavioural therapy conducted online
Arm group label:
CBT_ONLINE
Intervention type:
Other
Intervention name:
CBT_IN PERSON
Description:
10-12 sessions of cognitive behavioural therapy conducted in-person.
Arm group label:
CBT_IN PERSON
Summary:
Oncological diseases are considered a family disease because when one member is diagnosed
with cancer, the psycho-physical, social and economic consequences affect the entire
family. In Italy, approximately 17% of the population assists a family member. These
caregivers are typically unpaid individuals such as partners, offspring, and relatives
who provide daily support. In Italy, the prevalence of depressive disorders among
caregivers of patients with cancer ranges between 40%-70%. Therefore, providing
psychological support to patients and their caregivers throughout the illness and beyond
is essential. This support should include the assistance of psychologists and
psychotherapists experienced in coping with illness and grieving. Cognitive Behavioral
Therapy (CBT) refers to a series of interventions aimed at treating psychological
disorders by modifying dysfunctional cognitive factors that sustain and exacerbate this
condition. In the telemedicine setting, psychological teleconsultation is experiencing
extensive development, especially in the home setting for chronic illnesses. According to
the scientific literature, much evidence suggests no difference in the effectiveness of
psychological therapies provided telematically or in-person.
This study aims to evaluate the impact of CBT online or in-person intervention on anxiety
and depression symptoms. The intervention is designed for caregivers of patients with
cancer assisted at home. The sample population consists of caregivers of patients
assisted by the oncological palliative home care programme of ANT Foundation and
caregivers grieving for a loved one previously assisted by ANT Foundation.
Participants meeting the inclusion criteria will be randomised into two groups:
Online group: caregivers will receive an intervention of 10-12 psychological sessions in
the online setting.
In-person group: caregivers will receive the same CBT intervention lasting 10-12
psychological sessions, in-person.
We are expecting:
- Reduction in anxiety symptoms measured by comparison of the results obtained at T0
and T1 of the Generalized Anxiety Disorder Scale-7 (GAD-7) questionnaire
- Reduction in depressive symptoms measured by comparing the results obtained at T0
and T1 of the Patient Health Questionnaire-9 (PHQ-9) questionnaire.
Detailed description:
Background Oncological diseases are considered a family disease because when one member
is diagnosed with cancer, the psycho-physical, social and economic consequences affect
the entire family. In Italy, approximately 17% of the population assists a family member.
These caregivers are typically unpaid individuals such as partners, offspring, relatives
who provide daily support. In Italy, the prevalence of depressive disorders among
caregivers of patients with cancer ranges from 40% to 70%. Providing psychological
support to patients and their caregivers throughout the course of the illness, including
post-bereavement, is essential This support should include the assistance of
psychologists and psychotherapists experienced in coping with illness and grieving.
Cognitive Behavioral Therapy (CBT) refers to a series of interventions aimed at treating
psychological disorders by modifying dysfunctional cognitive factors that sustain and
exacerbate this condition. In the telemedicine setting, psychological teleconsultation is
experiencing extensive development, especially in the home setting for chronic illnesses.
Web-based psychological interventions have been proven effective in reducing anxiety and
depression symptoms and in improving the quality of life among various patient
populations and their relatives. The clinical outcomes are also comparable to
psychological interventions delivered in-person. Finally, a great deal of evidence
suggests that there is no difference in the effectiveness of psychological therapies
provided online or in-person.
Aim of the study The study aims to evaluate the impact of a CBT intervention conducted
online or in-person on anxiety and depression symptoms. The intervention is designed for
caregivers of patients with cancer assisted at home and for caregivers grieving for a
loved one previously assisted at home.
Primary aim
- Evaluation of the impact of a CBT intervention conducted online or in-person on
anxiety and depression symptoms.
Secondary aims
- Comparison between the results obtained with CBT intervention delivered online and
the same intervention delivered in-person.
- Evaluation of the therapists' degree of familiarity with the online setting.
- Evaluation of the caregivers' degree of satisfaction with the online intervention.
Study setting and target population
The sample population consists of:
i) caregivers of cancer patients assisted by the oncological palliative home care program
of ANT Foundation; ii) caregivers grieving for a loved one previously assisted by ANT
Foundation. This study model is part of the home care program provided by ANT Foundation
which takes care of patients with advanced cancer by focusing not only on the physical
effects of the disease but also on the patient's perception of health, with the primary
objective of improving quality of life of the patients and families, even after the
possible death of sick loved one. ANT Foundation aims to offer the possibility of living
the last period of life in one's family environment, acting on pain, suffering and
physical and psychological difficulties and on all the complex needs characterizing the
end-of-life. Each patient is supported by a multidisciplinary team of physicians, nurses,
and psychologists.
Study design The study follows a randomised, drug-free, non-profit, exploratory pre-post
interventional design.
Participants meeting the inclusion criteria will be randomized into two groups:
- Online group: caregivers or caregivers in bereavement processing will receive an
intervention of 10-12 psychological sessions of CBT in an online setting.
- In-person group: caregivers or caregivers in bereavement processing will receive the
same CBT intervention lasting 10-12 sessions, in-person.
If the participant does not have an Internet connection and a tool for
tele-consultations, ANT Foundation will provide.
Recruitment and data collection During the first psychological session, the psychologist
will explain the study and propose the participation to caregivers. Once consent has been
obtained, the psychologist will administer questionnaires to assess anxiety and
depression symptoms.
Caregivers meeting the inclusion criteria will be randomized by the ANT Research
Department into two arms (Online vs In-person Group) using a series of random numbers
generated by Excel.
Randomization The participants will be randomly assigned by the Research Department to
online (25 participants) or in-person group (25 participants) by a stratified
randomization using a random number list generated by Excel. The randomization list will
be kept secret (password protected) from the psychotherapists who will recruit the
caregivers. Furthermore, the psychologists will not know to which group the next
caregiver will be assigned.
Sample size It is expected that 50 participants will be included. Power analysis The
study's power was assessed by considering the reduction of anxiety and depression
symptoms (PHQ-9 and CAD-7 questionnaire scores) among 45 caregivers (estimating a 10%
dropout) between T0 and T1. The effect size was assumed based on studies in the
literature on the effect of a CBT intervention on depression (0.48-0.58) and anxiety
(0.38). The power of the study, calculated using G*Power software with a power post hoc
analysis for a Wilcoxon test for repeated measures, with α = 0.05, results in (1-β) =
0.68 for an effect size = 0.38, (1-β) = 0.86 for an effect size = 0.48 and (1-β) = 0.96
for an effect size = 0.58. The power of the study for 45 caregivers will range between
0.68 and 0.96.
Psychologists involved in the study Eight psychologists and psychotherapists specialized
in Cognitive-Behavioral Therapy (CBT) will participate in the study.
Supervisions and intervisions Monthly and for the entire duration of the study, the
psychologists involved in the project will participate in supervision, coordinated by a
Cognitive-Behavioural psychotherapist, expert in the management of group dynamics, both
in business and health contexts, to manage any issues that emerge during the work. In
addition, periodic intervisions will be planned, to promote an exchange on reciprocal
intervention experiences acquired during clinical activity, aiming at broadening the
frame of observation of problems and solutions and facilitating professionals in the
relationship with the patient.
Method The intervention framework is based on the theoretical principles and techniques
used in CBT. These therapeutic strategies are designed for targeted and customized
interventions for the specific audience of caregivers of cancer patients. To this end,
the therapeutic intervention used in the present study is built on the format of
Internet-based CBT programs (ICBT) of recognized effectiveness.
The intervention lasts 10-12 psychological sessions and includes a first phase of
diagnosis-assessment devoted to case formulation and a second intervention phase devoted
to the therapeutic process.The clinical intervention is organized into 11 modules that
represent a structural and conceptual guide and must be adapted by the therapist based on
the specific needs of the individual caregiver. It is specified that the modules do not
coincide with the progressive and sequential steps of therapy but represent a thematic
and instrumental guide that the psychologists will refer to. The modules can be
overlapping, repeatable and interchangeable depending on the needs that emerge during the
course. The aim is to provide a shared and operational structure available to
psychologists, but, at the same time, to ensure flexibility and adaptability tailored to
the contingency and peculiarities of each case.
Two introductory modules are devoted to the initial psychological sessions and problem
analysis:
1. Introduction to the problem.
2. Problem analysis. The goal of the first clinical sessions is to gather basic
anamnestic information such as the caregiver's medical and family history,
through active and empathic listening aimed at collecting the data necessary for a
comprehensive understanding and analysis of the problem. In this way, automatic
negative thoughts and core beliefs are identified to arrive at a definition of the
therapeutic goals to be shared with the caregiver. The tools that can be used by
professionals fall within the range of recognized techniques routinely used in CBT,
such as the ABC technique, CEPA Functional Analysis, the Thought Diary, and the
Coping Styles Worksheet.
After the case formulation phase, the subsequent therapeutic process is developed in
8 specific modules plus an additional module on grief divided by objectives:
3. Psycho-education phase: information is shared with the caregiver about the CBT
approach according to which the intervention is set up, and in which an attempt is
made to increase awareness of the caregiving role and the resulting burden.
4. Changing dysfunctional cognitions: tools such as the Socratic dialogue and cognitive
restructuring and reactions on the emotional level are used.
5. Enhancement of coping skills: coping with the changes that illness brings about in
daily life.
6. Enhancement of social skills fostering the building and maintenance of support
networks.
7. Empowerment of the family member's resources: focus on their specific needs.
8. Acceptance of change and illness of loved one: practices such as mindfulness, ACT,
etc. are used.
9. Drafting and planning a series of pleasant activities to lighten the caregiving
burden. Tools such as pleasant activity scheduling, relapse prevention plan, etc.
are used.
10. Phase of feedback and evaluation of the intervention outcomes: shared verification
of the changes and achievement of the set goals, enhancement of the resources that
emerged in the therapeutic path to better manage the difficulties identified.
11. Bereavement Processing: in a setting of caring for advanced cancer patients, there
is a possibility that the progression of the disease will lead caregivers to
confront the death of the family member. Clearly, the caregiver's psychological
intake pathway must take this possibility into account and adjust the intervention
to include work on possible grief processing. For this purpose, the protocol
includes a specific module dedicated to the characteristic challenges of processing
loss, within which the therapist can move to restructure goals and adapt them to the
contingency of grief, following the cognitive-behavioral Dual Process Model.
The concluding phase is also devoted to assessing the caregiver's satisfaction with the
intervention by filling out a dedicated questionnaire at T1.
As mentioned, the therapist will tailor the intervention based on the case formulation
and the caregiver's needs and requests, following the structure of the protocol and the
specific objectives of each module.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Presence of anxious-depressive symptomatology, included in the cut-off 5-21 of the
Generalized Anxiety Disorder Scale-7 (GAD-7) and/or in the cut-off 5-27 of the
Patient Health Questionnaire-9 (PHQ-9).
- Aged 18 years or older.
- Able to understand the aims of the study and to sign the informed consent.
- Able to understand the Italian language.
- Able to use a technological tool for tele-consultations (smartphone, tablet,
computer, etc.).
Exclusion Criteria:
- With severe psychiatric pathology causing clinically significant impairment of
functioning in social, occupational or other important areas.
- With cognitive impairment.
- Engaged in psychological support/psychotherapy within the last 3 months.
- Who does not meet the inclusion criteria.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione ANT
Address:
City:
Bologna
Zip:
40128
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Rita Ostan, PhD
Phone:
+393487900191
Email:
rita.ostan@ant.it
Contact backup:
Last name:
Andrea Giannelli
Phone:
+393475225352
Email:
andrea.giannelli@ant.it
Contact backup:
Last name:
Silvia Varani, silvia.varani@ant.it
Contact backup:
Last name:
Luca Franchini
Contact backup:
Last name:
Melania Raccichini
Contact backup:
Last name:
Daniele Roganti
Contact backup:
Last name:
Damiano Periccioli
Contact backup:
Last name:
Manuela Benedetto
Contact backup:
Last name:
MIchela Perrella
Contact backup:
Last name:
Sara Scibè
Contact backup:
Last name:
Serena Paladini
Start date:
February 1, 2024
Completion date:
January 31, 2026
Lead sponsor:
Agency:
Fondazione ANT Italia ONLUS
Agency class:
Other
Source:
Fondazione ANT Italia ONLUS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06592573
