Interpersonal PsychotherapyIPT-GNCT05870384
Application of Group Interpersonal Psychotherapy (IPT-G) to Family Members Caring for Patients With Schizophrenia
A study testing Group Interpersonal Psychotherapy in people with Interpersonal Psychotherapy and Family Caregivers, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this re-measured quasi-experimental study is to evaluate the effect of Group Interpersonal Psychotherapy (IPT-G) intervention given to caregiver family members of people with schizophrenia on caregiver burden, perception of social support and stigma, adherence to treatment in people with schizophrenia they… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Interpersonal Psychotherapy, Family Caregivers
- What is being tested?
- Group Interpersonal Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2024to Apr 2025
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be between the ages of 18-65
- Being able to speak and understand fluent Turkish,
- Being the primary caregiver of a family member with one of the Schizophrenic Disorders and Psychotic Disorders,
- Caring for a family member with Schizophrenia and Schizophrenia Spectrum Disorder for at least 6 months.
- Both the caregiver and the patient voluntarily agree to participate in the study.
Who cannot join
- Having a dismissive attachment style (to be evaluated by the researcher),
- Having antisocial personality traits (to be evaluated by the researcher),
- Having narcissistic personality traits (to be evaluated by the researcher),
- Having active suicidal ideation (to be evaluated by the investigator).
- Removal criteria:
- Not attending more than two sessions of the 7-session intensive/group phase
- Failure to comply with the norms and rules of group therapy (continuity, confidentiality, respectful communication, interaction with group members, participation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Group Interpersonal Psychotherapy (IPT-G) Applied to Family Members Who Caregivers of Patients With Schizophrenia on Caregiver Burden, Social Support, Expression of Emotion, Stigma, and Adherence to Treatment
The goal of this re-measured quasi-experimental study is to evaluate the effect of Group Interpersonal Psychotherapy (IPT-G) intervention given to caregiver family members of people with schizophrenia on caregiver burden, perception of social support and stigma, adherence to treatment in people with schizophrenia they care for, and emotional expression in both caregivers and people with schizophrenia they care for. The main hypotheses it aims to test are:
- IPT-G intervention will reduce the caregiver burden of caregivers of individuals with schizophrenia.
- IPT-G intervention will increase the perceived social support levels of caregivers of individuals with schizophrenia.
- IPT-G intervention will reduce the level of stigma of caregivers of individuals with schizophrenia.
- IPT-G intervention will reduce the level of emotional expression of caregivers of individuals with schizophrenia.
- IPT-G intervention applied to caregivers will increase the level of adherence to treatment of individuals with schizophrenia they care for.
- IPT-G intervention applied to caregivers will reduce the emotional expression levels of individuals with schizophrenia they care for.
Read the detailed description
Family members who care for individuals with a chronic mental illness such as schizophrenia are exposed to many risks such as stress, fatigue, depression, care burden, stigma, problems in family and interpersonal relationships, conflicts, financial difficulties, social isolation, disruption of daily routines. IPT is a short-term psychotherapy that works on specific interpersonal problem areas associated with depression, anxiety, and general psychological distress. IPT focuses on the following interpersonal problem areas: grief or complicated dispute, bereavement, role, role transition, interpersonal deficits . In these problem areas, IPT is applied individually as well as as group psychotherapy. IPT-G is carried out with group members who share a common distress. IPT-G is more structured than individual IPT. There is a practitioner's guide. IPT-G has a specific agenda, structure and defined endpoint. In IPT-G, the group usually has 6-10 members. Sessions last approximately 90 minutes. The main objectives of IPT-G can be summarized as 1) psychoeducation, 2) increasing social support, 3) solving interpersonal problems. In this sense, the application of IPT-G in the caregivers of individuals with schizophrenia may be promising both for the caregivers and the patients they care for. Therefore, family members who care for individuals diagnosed with schizophrenia living in Turkey/Bolu province, who are willing to participate in the IPT-G intervention, and who meet the inclusion/exclusion criteria of the study will constitute the sample of the study. Participants will be selected from the caregivers of the patients reached from Bolu Abant İzzet Baysal University, İzzet Baysal Training and Research Hospital and Bolu İzzet Baysal Mental Health and Diseases Hospital. A poster inviting the caregivers of the patients will be prepared and hung in the hospitals. Group psychotherapy intervention for the caregivers of patients who meet the inclusion and exclusion criteria of the study will be carried out in a training room in Bolu Abant İzzet Baysal University, Faculty of Health Sciences, Department of Nursing, where the researchers work. The group therapy will be made by the researcher, a licensed psychotherapist. IPT-G will only be applied to caregivers. No application will be made to the patients. In addition, it will be measured whether the intervention applied to the caregivers indirectly has any effect on the patient. Persons to be included in the application will be informed about the application. Signed consent will be obtained. In order to include individuals in the IPT-G intervention, the researcher who will conduct the application will conduct two one-on-one interviews with caregivers to evaluate whether they are suitable for group intervention. The therapist will include caregivers with a similar problem focus in the group. Since it is suggested that the IPT-G group intervention should consist of 6-10 people, this number will be taken as the basis. Group therapy will be done once a week. Sessions will last approximately 90 minutes. The intervention will be completed in a total of ten sessions, with two-session individual interviews and eight-session group sessions. Measurement tools will be applied to caregivers and the patients they care for at the beginning of the group therapy, at the end of the last session, at the end of the third month following the end of the sessions, and at the end of the sixth month following the end of the sessions. A total of four measurements will be made. Scales and sociodemographic data form will be used as data collection tools.Sociodemographic data collection form, Emotional Expression Scale Caregiver Version, Stigma Scale for the Families of Psychiatric Patients (SCFPP), Zarit Caregiver Burden Interview, Multidimensional Scale of Perceived Social Support will be administered face-to-face to caregivers in the IPT-G intervention. The Patient Version of the Emotion Expression Scale and The Medication Adherence Report Scale will be applied to the individuals diagnosed with schizophrenia, who are cared for by the caregivers in the IPT-G intervention.At the end of the experiment, the "t-test for dependent groups" will be used, in which the averages of the pre-test and post-test scores are compared whether the results are significant or not.The research complies with the ethical principles of benefit and non-harm. There is no aspect of the research that could pose a risk or cause harm to the participants. The research intervention is envisaged to provide beneficial outcomes to the participants. Shares made during individual interviews and group sessions will be kept confidential under the principle of protecting privacy. Privacy and confidentiality is the norm of the group and compliance by all participants will be contractually assured and encouraged. Researchers will not share therapy notes unless they pose a risk to the individual, his/her environment and other third parties, unless there is a judicial process.
- Conditions
- Interpersonal Psychotherapy, Family Caregivers
- Being tested
- Group Interpersonal Psychotherapy
- Keywords
- Interpersonal Psychotherapy, Schizophrenia, Caregiver Burden, Social Support, Social Stigma, Treatment Adherence and Compliance, Expressed Emotion
- Medical subject headings
- Schizophrenia, Caregiver Burden, Social Stigma, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Interpersonal PsychotherapyBehavioural
Ten sessions of IPT-G, which focuses on the common problem area of patient relatives, will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy | Experimental | Group psychotherapy will be applied to a single intervention group. Receives: Behavioral: Group Interpersonal Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in caregiver burden evaluated with the Zarit Caregiver Burden Scale (ZCBS)
The primary outcome measure of the study is the care burden. Caregivers' burden will be evaluated with repeated tests before and after the intervention. For this, the "Zarit Caregiver Burden Scale (ZCBS)" scale will be used.The scale will be applied only to caregivers who participate in the group psychotherapy intervention.
Zarit Caregiver Burden Scale (ZCBS): The scale consists of 22 items. It includes the negative effects of caregiving on physical, mental health, social activity and economic resources.The total score varies between 22-110. The higher the scores, the higher the level of burden. It is expected that the burden of care score will decrease in the measurements made after the intervention.
Measured: Change in caregiver burden at 6 months
Secondary outcomes (4)
Change in expression of emotion evaluated with Expression of Emotion Scale and Level of Expressed Emotion Scale
Expression of emotion will be measured both in caregivers participating in group psychotherapy intervention and in patients they care for without intervention with repeated tests before and after the intervention.
Expression of Emotion Scale: This scale will be filled by caregivers. The scale consists of 41 "true/false" questions. The higher the scores, the higher the level of emotional expression. The total score ranges from 0 to 41.It is expected that the expression of emotion score will decrease in the measurements made after the intervention.
Level of Expressed Emotion Scale:This scale will be filled by patients. The scale asks patients to evaluate the attitude of their caregivers towards them. The scale consists of 60 "true/false" questions. The total score ranges from 0 to 60.It is expected that the expression of emotion score will decrease in the measurements made after the intervention.
Measured: Change in expression of emotion at 6 months
Change in stigma evaluated with the Stigma Scale for the Families of Psychiatric Patients (SCFPP)
Stigma will be evaluated with repeated tests before and after the intervention. For this, the "Stigma Scale for the Families of Psychiatric Patients (SCFPP)" scale will be used.The scale will be applied only to caregivers who participate in the group psychotherapy intervention.
Stigma Scale for the Families of Psychiatric Patients (SCFPP): The scale consists of 17 items. Scoring of the scale is made as the lowest 1 and the highest 3 points; cut-off score was calculated as 1.67.The higher the scores, the higher the level of stigma.It is expected that the stigma score will decrease in the measurements made after the intervention.
Measured: Change in stigma at 6 months
Change in perceived social support evaluated with the Multidimensional Scale of Perceived Social Support (MSPSS)
Perceived social support will be evaluated with repeated tests before and after the intervention. For this, the "Multidimensional Scale of Perceived Social Support (MSPSS)" scale will be used.The scale will be applied only to caregivers who participate in the group psychotherapy intervention.
Multidimensional Scale of Perceived Social Support (MSPSS): The scale consists of 12 items. The total score varies between 0-84. A high score indicates high perceived social support. It is expected that the perceived social support score will increase in the measurements made after the intervention.
Measured: Change in perceived social support at 6 months
Change in medication adherence evaluated with the Medication Adherence Rating Scale (MARS)
Medication adherence will be evaluated with repeated tests before and after the intervention. For this, the "Medication Adherence Rating Scale (MARS)" scale will be used.The scale will be applied to patients cared for by caregivers participating in the intervention.
Medication Adherence Rating Scale (MARS):The scale consists of 10 "yes/no" questions.The total score varies between 1-10.Low scores on the scale indicate poor adherence to treatment, and high scores indicate high adherence to treatment. 1 and 7 points shows that poor adherence to treatment, between 8 and 10 were high. It is expected that the perceived social support score will increase in the measurements made after the intervention.
Measured: Change in medication adherence at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study startJul 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionApr 2025 (estimated)
Why it stopped: People didn't apply. The number of participants required to begin the intervention was not reached.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Interpersonal PsychotherapyStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a single group Remeasurement Quasi-experimental Study. The intervention in the study is the application of IPT-G to the caregivers of the patients with schizophrenia. The intervention consists of 10 sessions to be held once a week. The first 2 sessions will be individual, followed by 8 group sessions. Sessions will last an average of 90 minutes. The group is a closed group, no new participants will be accepted after the sessions have started. The study will measure the impact of the therapy on both the caregivers and patients, with follow-up evaluations at 3 and 6 months after the sessions. At the end of the experiment, the "t-test for dependent groups" will be used, in which the averages of the pre-test and post-test scores are compared whether the results are significant or not.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melisa BULUT, Abant Izzet Baysal University
- Investigators
- Melisa Bulut, Study director, Abant Izzet Baysal UniversityNazmiye Yıldırım, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870384
- Sponsor's protocol ID
- AIBU-PSK-MB-01
- Acronym
- IPT-G
- Status last verified
- Aug 2024
- First submitted
- 25 Mar 2023
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cuijpers P, Donker T, Weissman MM, Ravitz P, Cristea IA. Interpersonal Psychotherapy for Mental Health Problems: A Comprehensive Meta-Analysis. Am J Psychiatry. 2016 Jul 1;173(7):680-7. doi: 10.1176/appi.ajp.2015.15091141. Epub 2016 Apr 1.
PubMed 27032627Arslantas H. The burden of schizophrenia on caregivers. Current Approaches in Psychiatry. 2011; 3(2):251-277.
Chang KH, Horrocks S. Lived experiences of family caregivers of mentally ill relatives. J Adv Nurs. 2006 Feb;53(4):435-43. doi: 10.1111/j.1365-2648.2006.03732.x.
PubMed 16448486Stuart S, Schultz J. IPT for Groups Clinician's Handbook. IPT Institute. 2016
Chen WY, Lukens E. Well being, depressive symptoms, and burden among parent and sibling caregivers of persons with severe and persistent mental illness. Social Work in Mental Health. 2011; 9(6): 397-416.
Durmaz H, Okanli A. Effects of interpersonal psychotherapy (ipt) techniques and psychoeducation on self-efficacy and care burden in families of patients with schizophrenia. American Journal of Family Therapy. 2021; 49(4): 373-391.
Mutamba BB, Kane JC, de Jong JTVM, Okello J, Musisi S, Kohrt BA. Psychological treatments delivered by community health workers in low-resource government health systems: effectiveness of group interpersonal psychotherapy for caregivers of children affected by nodding syndrome in Uganda. Psychol Med. 2018 Nov;48(15):2573-2583. doi: 10.1017/S0033291718000193. Epub 2018 Feb 15.
PubMed 29444721Glanville DN, Dixon L. Caregiver burden, family treatment approaches and service use in families of patients with schizophrenia. Isr J Psychiatry Relat Sci. 2005;42(1):15-22.
PubMed 16134403
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Group Interpersonal Psychotherapy (IPT-G) Applied to Family Members Who Caregivers of Patients With Schizophrenia on Caregiver Burden, Social Support, Expression of Emotion, Stigma, and Adherence to Treatment
- ClinicalTrials.gov ID
- NCT05870384
- Acronym / sponsor ID
- IPT-G / AIBU-PSK-MB-01
- Conditions
- Interpersonal Psychotherapy, Family Caregivers
- Keywords
- Interpersonal Psychotherapy, Schizophrenia, Caregiver Burden, Social Support, Social Stigma, Treatment Adherence and Compliance, Expressed Emotion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: People didn't apply. The number of participants required to begin the intervention was not reached.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 23 May 2023 (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 goal of this re-measured quasi-experimental study is to evaluate the effect of Group Interpersonal Psychotherapy (IPT-G) intervention given to caregiver family members of people with schizophrenia on caregiver burden, perception of social support and stigma, adherence to treatment in people with schizophrenia they care for, and emotional expression in both caregivers and people with schizophrenia they care for. The main hypotheses it aims to test are:
- IPT-G intervention will reduce the caregiver burden of caregivers of individuals with schizophrenia.
- IPT-G intervention will increase the perceived social support levels of caregivers of individuals with schizophrenia.
- IPT-G intervention will reduce the level of stigma of caregivers of individuals with schizophrenia.
- IPT-G intervention will reduce the level of emotional expression of caregivers of individuals with schizophrenia.
- IPT-G intervention applied to caregivers will increase the level of adherence to treatment of individuals with schizophrenia they care for.
- IPT-G intervention applied to caregivers will reduce the emotional expression levels of individuals with schizophrenia they care for.
Detailed description
Family members who care for individuals with a chronic mental illness such as schizophrenia are exposed to many risks such as stress, fatigue, depression, care burden, stigma, problems in family and interpersonal relationships, conflicts, financial difficulties, social isolation, disruption of daily routines. IPT is a short-term psychotherapy that works on specific interpersonal problem areas associated with depression, anxiety, and general psychological distress. IPT focuses on the following interpersonal problem areas: grief or complicated dispute, bereavement, role, role transition, interpersonal deficits . In these problem areas, IPT is applied individually as well as as group psychotherapy. IPT-G is carried out with group members who share a common distress. IPT-G is more structured than individual IPT. There is a practitioner's guide. IPT-G has a specific agenda, structure and defined endpoint. In IPT-G, the group usually has 6-10 members. Sessions last approximately 90 minutes. The main objectives of IPT-G can be summarized as 1) psychoeducation, 2) increasing social support, 3) solving interpersonal problems. In this sense, the application of IPT-G in the caregivers of individuals with schizophrenia may be promising both for the caregivers and the patients they care for. Therefore, family members who care for individuals diagnosed with schizophrenia living in Turkey/Bolu province, who are willing to participate in the IPT-G intervention, and who meet the inclusion/exclusion criteria of the study will constitute the sample of the study. Participants will be selected from the caregivers of the patients reached from Bolu Abant İzzet Baysal University, İzzet Baysal Training and Research Hospital and Bolu İzzet Baysal Mental Health and Diseases Hospital. A poster inviting the caregivers of the patients will be prepared and hung in the hospitals. Group psychotherapy intervention for the caregivers of patients who meet the inclusion and exclusion criteria of the study will be carried out in a training room in Bolu Abant İzzet Baysal University, Faculty of Health Sciences, Department of Nursing, where the researchers work. The group therapy will be made by the researcher, a licensed psychotherapist. IPT-G will only be applied to caregivers. No application will be made to the patients. In addition, it will be measured whether the intervention applied to the caregivers indirectly has any effect on the patient. Persons to be included in the application will be informed about the application. Signed consent will be obtained. In order to include individuals in the IPT-G intervention, the researcher who will conduct the application will conduct two one-on-one interviews with caregivers to evaluate whether they are suitable for group intervention. The therapist will include caregivers with a similar problem focus in the group. Since it is suggested that the IPT-G group intervention should consist of 6-10 people, this number will be taken as the basis. Group therapy will be done once a week. Sessions will last approximately 90 minutes. The intervention will be completed in a total of ten sessions, with two-session individual interviews and eight-session group sessions. Measurement tools will be applied to caregivers and the patients they care for at the beginning of the group therapy, at the end of the last session, at the end of the third month following the end of the sessions, and at the end of the sixth month following the end of the sessions. A total of four measurements will be made. Scales and sociodemographic data form will be used as data collection tools.Sociodemographic data collection form, Emotional Expression Scale Caregiver Version, Stigma Scale for the Families of Psychiatric Patients (SCFPP), Zarit Caregiver Burden Interview, Multidimensional Scale of Perceived Social Support will be administered face-to-face to caregivers in the IPT-G intervention. The Patient Version of the Emotion Expression Scale and The Medication Adherence Report Scale will be applied to the individuals diagnosed with schizophrenia, who are cared for by the caregivers in the IPT-G intervention.At the end of the experiment, the "t-test for dependent groups" will be used, in which the averages of the pre-test and post-test scores are compared whether the results are significant or not.The research complies with the ethical principles of benefit and non-harm. There is no aspect of the research that could pose a risk or cause harm to the participants. The research intervention is envisaged to provide beneficial outcomes to the participants. Shares made during individual interviews and group sessions will be kept confidential under the principle of protecting privacy. Privacy and confidentiality is the norm of the group and compliance by all participants will be contractually assured and encouraged. Researchers will not share therapy notes unless they pose a risk to the individual, his/her environment and other third parties, unless there is a judicial process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a single group Remeasurement Quasi-experimental Study. The intervention in the study is the application of IPT-G to the caregivers of the patients with schizophrenia. The intervention consists of 10 sessions to be held once a week. The first 2 sessions will be individual, followed by 8 group sessions. Sessions will last an average of 90 minutes. The group is a closed group, no new participants will be accepted after the sessions have started. The study will measure the impact of the therapy on both the caregivers and patients, with follow-up evaluations at 3 and 6 months after the sessions. At the end of the experiment, the "t-test for dependent groups" will be used, in which the averages of the pre-test and post-test scores are compared whether the results are significant or not.
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy | Experimental | Behavioral: Group Interpersonal PsychotherapyGroup psychotherapy will be applied to a single intervention group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be between the ages of 18-65
- Being able to speak and understand fluent Turkish,
- Being the primary caregiver of a family member with one of the Schizophrenic Disorders and Psychotic Disorders,
- Caring for a family member with Schizophrenia and Schizophrenia Spectrum Disorder for at least 6 months.
- Both the caregiver and the patient voluntarily agree to participate in the study.
Key exclusion criteria (7 listed)
- Having a dismissive attachment style (to be evaluated by the researcher),
- Having antisocial personality traits (to be evaluated by the researcher),
- Having narcissistic personality traits (to be evaluated by the researcher),
- Having active suicidal ideation (to be evaluated by the investigator).
- Not attending more than two sessions of the 7-session intensive/group phase
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 |
|---|---|---|
| Group Interpersonal PsychotherapyTen sessions of IPT-G, which focuses on the common problem area of patient relatives, will be applied. | Behavioural | Psychotherapy |
Primary outcome
Change in caregiver burden evaluated with the Zarit Caregiver Burden Scale (ZCBS)
Time frame: Change in caregiver burden at 6 months
The primary outcome measure of the study is the care burden. Caregivers' burden will be evaluated with repeated tests before and after the intervention. For this, the "Zarit Caregiver Burden Scale (ZCBS)" scale will be used.The scale will be applied only to caregivers who participate in the group psychotherapy intervention. Zarit Caregiver Burden Scale (ZCBS): The scale consists of 22 items. It includes the negative effects of caregiving on physical, mental health, social activity and economic resources.The total score varies between 22-110. The higher the scores, the higher the level of burden. It is expected that the burden of care score will decrease in the measurements made after the intervention.
4 secondary outcomes
Change in expression of emotion evaluated with Expression of Emotion Scale and Level of Expressed Emotion Scale
Time frame: Change in expression of emotion at 6 months
Change in stigma evaluated with the Stigma Scale for the Families of Psychiatric Patients (SCFPP)
Time frame: Change in stigma at 6 months
Change in perceived social support evaluated with the Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Change in perceived social support at 6 months
Change in medication adherence evaluated with the Medication Adherence Rating Scale (MARS)
Time frame: Change in medication adherence at 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Background: PubMed 27032627Cuijpers P, Donker T, Weissman MM, Ravitz P, Cristea IA. Interpersonal Psychotherapy for Mental Health Problems: A Comprehensive Meta-Analysis. Am J Psychiatry. 2016 Jul 1;173(7):680-7. doi: 10.1176/appi.ajp.2015.15091141. Epub 2016 Apr 1.
- BackgroundArslantas H. The burden of schizophrenia on caregivers. Current Approaches in Psychiatry. 2011; 3(2):251-277.
- Background: PubMed 16448486Chang KH, Horrocks S. Lived experiences of family caregivers of mentally ill relatives. J Adv Nurs. 2006 Feb;53(4):435-43. doi: 10.1111/j.1365-2648.2006.03732.x.
- BackgroundStuart S, Schultz J. IPT for Groups Clinician's Handbook. IPT Institute. 2016
- BackgroundChen WY, Lukens E. Well being, depressive symptoms, and burden among parent and sibling caregivers of persons with severe and persistent mental illness. Social Work in Mental Health. 2011; 9(6): 397-416.
- Results publicationDurmaz H, Okanli A. Effects of interpersonal psychotherapy (ipt) techniques and psychoeducation on self-efficacy and care burden in families of patients with schizophrenia. American Journal of Family Therapy. 2021; 49(4): 373-391.
- Results publication: PubMed 29444721Mutamba BB, Kane JC, de Jong JTVM, Okello J, Musisi S, Kohrt BA. Psychological treatments delivered by community health workers in low-resource government health systems: effectiveness of group interpersonal psychotherapy for caregivers of children affected by nodding syndrome in Uganda. Psychol Med. 2018 Nov;48(15):2573-2583. doi: 10.1017/S0033291718000193. Epub 2018 Feb 15.
- Results publication: PubMed 16134403Glanville DN, Dixon L. Caregiver burden, family treatment approaches and service use in families of patients with schizophrenia. Isr J Psychiatry Relat Sci. 2005;42(1):15-22.
- 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. This study is not recruiting at the moment.
Melisa Bulut study director
Abant Izzet Baysal University
Nazmiye Yıldırım principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Interpersonal Psychotherapy in people with Interpersonal Psychotherapy and Family Caregivers, run by Abant Izzet Baysal 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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 7 Aug 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in caregiver burden evaluated with the Zarit Caregiver Burden Scale (ZCBS) (time frame: Change in caregiver burden at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05870384, which also lists 8 linked publications.
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 7 Aug 2024.