Breast CancerNCT05259267
Online Group Therapy for Breast Cancer
A study testing Online Group Therapy for PTG and Online Support Group in people with Breast Cancer, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Breast cancer is a serious and life-threatening health problem that is increasing all over the world and in Turkey. Although the survival rate increases with the improvement of the diagnosis and treatment processes for breast cancer, cancer patients experience some psychosocial problems both due to their treatment and… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Online Group Therapy for PTG and Online Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2022to Oct 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women who have been diagnosed with breast cancer for the first and only
- women who have been diagnosed breast cancer in 2018 and later (past four years)
- stage I, II and III patients
- ability to use internet
- having a personal computer or tablet with a camera and microphone
- describing cancer as a stressful life event (using PCL-5 to assess post-traumatic stress level)
Who cannot join
- recurrence of breast cancer,
- second cancer,
- severe psychological or physical comorbidity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Eskişehir Osmangazi University Faculty of Medicine
Eskişehir, 26040
Cennet Yastıbaş-Kaçar, MD, +905346320490, cennet.yastibas@deu.edu.tr
İmran Gökçen Yılmaz-Karaman, Dr
About this study
Official title: Investigation of the Effectiveness of an Online Group Therapy Program for Post-Traumatic Growth in Women With Breast Cancer
Breast cancer is a serious and life-threatening health problem that is increasing all over the world and in Turkey. Although the survival rate increases with the improvement of the diagnosis and treatment processes for breast cancer, cancer patients experience some psychosocial problems both due to their treatment and the disease. Decreases in quality of life, psychological distress, especially depression and anxiety, post-traumatic stress disorder as well as sleep disorders, fatigue, fear of cancer recurrence could be common negative outcomes that experienced by the breast cancer patients. Although, cancer could be such a life-threatening disease, some patients report that they experience positive changes in their lives after the diagnosis of cancer. The concept of Post-Traumatic Growth (PTG) was first developed by Tedeschi and Calhoun (1995). PTG is a concept that refers positive psychological changes after struggling an stressful life event. According to the Functional-Descriptive model of Tedeschi and Calhoun, post-traumatic growth occurs in five areas; relating to others, personal strength, spiritual changes and appreciation of life. In this context, a group intervention program has been developed for PTG, which will bring the person to a better functionality than before the trauma to enhance the Post-Traumatic Growth level of women with breast cancer. The current research project will consist of three arms; therapy group, support group and wait-list. Online group therapy consists of eight sessions that continue approximately 90 minutes. In addition to an active treatment group for PTG, an online support group has been developed by the researchers to investigate the effectiveness of the therapy. Online support group also consists of eight sessions during approximately 90 minutes as in intervention program. Wait-list is considered as a control group. A set of reliable and validated measurement tools will be administered and heart rate variability as a physical measurement will be used to examine the effects of the therapy. The research hypotheses are based on that patients who participated active treatment group will have better PTG level and other related concept with PTG (like higher score of deliberate rumination) and better Heart-Rate Variability scores than other groups. The researcher will plan to take three time measurement: pre-intervention, post-intervention, and 1-month follw-up.
Read the detailed description
Preliminary studies to development of the programs Before the development of protocol of the current treatment programs, the investigators reviewed related literature and published a systematic review about the related factors for PTG in women with breast cancer. After obtaining the ethical approval the study coordinator interviewed with eight women via telephone to explore the experiences of women with breast cancer. The investigators determined the needs and possible challenges of the illness. Besides, previous similar treatment programs were examined in detail. Later, the investigator developed the study protocol with the supervisor and send the content of the treatment programs to five specialists who have MD in clinical psychology and got feedback and the investigators revisited final version of the treatment programs.
In brief, the research hypotheses are 1) both online group therapy for PTG and online support groups will show better PTG levels and rumination scores, and other secondary measurements (such as psychological distress, heart rate variability, disclosure of distress) than wait-list control. 2) Participants who in online group therapy for PTG will improve better PTG and rumination scores, and secondary measurements' scores compared with the participants in online support groups. 3) The benefits of the treatment programs will be endured for 1-month follow-up measure.
Procedure Ethical approval: This study was approved by the institutional review board of Eskisehir Osmangazi University. All study participants gave written informed consent. Announcements will be posted in various departments of the hospital to participate in the research. First of all, volunteer participants will be assessed through the phone and informed about the research process. If they agree to participate, the investigators will organize a detailed interview. In this interview one of the researchers of the study who is a psychiatrist will apply SCID to eliminate the other possible mental disorder. Patients who meet the criteria will be informed about the group and informed consent forms will be obtained. Before beginning of the treatment program, baseline measurement and ECG Holter measurement will be scheduled by the telephone. After completing baseline measurement, the participants will then be randomly allocated to one of the three groups.
The online treatment programs will be delivered to groups of 6-8 participants by a psychologist and psychiatrist (therapist and co-therapist), eight weekly online sessions. Online sessions will be delivered through an online video-conferencing software (ZOOM). Sample size is determined by g-power analysis. For three-arm randomized controlled trial we plan to recruit at least 51 participants (each group should have at least 17 participants). Before the beginning of the study, the participants will be informed about online video-conferencing platform. The investigators will send a video about the use of platform and also step by step user manual. Each participant in treatment programs should join at least six sessions. If the participants could not complete six sessions, the investigators will admit them drop-out (This information will be declared during the interviews and written informed consent). The investigators will use SPSS 23.0 Package Program for Social Sciences. The descriptive analysis will be performed for frequencies of socio-demographics and clinical information such as cancer stage, treatments. To test the hypothesis, the investigators will conduct a repeated measure ANOVA. The investigators will employ intention to treat and as treated analysis.
- Conditions
- Breast Cancer
- Being tested
- Online Group Therapy for PTG, Online Support Group
- Keywords
- breast cancer, post-traumatic growth, online group therapy, online support groups
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Group Therapy for PTGBehavioural
Online Group Therapy for PTG consists of eight sessions. Each sessions have specific themes. First session: psychoeducation, normalization of the experiences and emotions. Second session: emotion regulation skills. Third session: awareness of the negative thoughts that make patients worried, anxious, feared. Forth session: restructuring of the thoughts and practicing mindfulness technics. 5. session: practicing of self-disclosure skills 6. session: creating a breast cancer story with balancing losses and gains. 7. session: sharing of the effects of breast cancer on life and developing new life priorities 8. session: making life meaning and developing new life goals.
Online Support GroupBehavioural
Online support groups also consist of eight sessions. 1. session: introducing the program and learning the expectancies 2. session: sharing what is known about breast cancer 3. session: risk and protective factors for breast cancer 4. session: sharing side effects of surgical operation and treatments 5. session: sharing the reactions of family, close friends 6. session: patient-doctor relationship and also sharing the challenges and facilitators of healthcare system 7. session: sharing the current position in the treatment and of what has been done for improvement 8. session: sharing the reliable information sources for breast cancer and close
| Study group | Role | What they receive |
|---|---|---|
| Online Group Therapy for PTG | Experimental | It consists of eight sessions that occur during app. 90 minutes. A group therapist and a cotherapist will lead the therapy sessions. There will be one session per a week. Receives: Behavioral: Online Group Therapy for PTG |
| Online Support Group | Active comparator | It consists of eight sessions that occur during app. 90 minutes. A group therapist and a cotherapist will lead the therapy sessions without using any psychological methods. There will be one session per a week. Receives: Behavioral: Online Support Group |
| Wait-list | No intervention | We used a wait-list as a control group. After each participants in both online PTG group therapy and online support group completed the interventions, wait-list will be randomly assigned to one of these two interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post-traumatic Growth Inventory
The Turkish version of Post-traumatic Growth Inventory to measure PTG levels of the patients will be used. It is compromised of 21 item and scored ranging from 0 to 5. Higher scores refer higher PTG level.
Measured: Baseline measurement before the treatment programs begin (pre-intervention),post-intervention at week 8(after completing eight week intervention), and 1-month follow-up.
Change in Event-Related Rumination Inventory (ERRI)
The Turkish version of Event-Related Rumination Inventory (ERRI) that is reliable and validated measure will be used to assess rumination of the breast cancer. It has 20 items and two sub-scale; intrusive and deliberate rumination. The scores are changing from 0 to 3.
Measured: Baseline measurement before the treatment programs begin (pre-intervention),post-intervention at week 8 (after completing eight-week intervention), and 1-month follow-up.
PTSD Checklist for DSM-5 (PCL-5)
It will be used to asses stressful level of breast cancer to participate the treatment programs.The 20-item self-report measure of PTSD scored from 0 to 4, and yielding a scale score range of 0-80.
Measured: Baseline measurement to deciding to join the treatment programs
Secondary outcomes (3)
Change in Depression Anxiety and Stress Scale (DASS-21)
The Turkish version of Depression Anxiety and Stress Scale which is a reliable and validated study result will be used for secondary outcome. It consists of 21 items and three sub scale. Higher scores of each sub-scale sign higher distress level.
Measured: Baseline measurement before the treatment programs begin (pre-intervention),post-intervention at week 8(after completing eight week intervention), and 1-month follow-up.
Change in Heart-Rate Variability
Holter electrocardiogram (ECG) Monitoring will be used to asses physical effects of intervention programs. It will be used 24 hour holter. A cardiologist will read the holter ECG results. Heart rate will be analyzed using the standard deviation of sequential interbeat intervals averaged over 5 min epochs (SDANN)
Measured: Baseline measurement before the treatment programs begin (pre-intervention),post-intervention at week 8(after completing eight week intervention), and 1-month follow-up.
Change in Distress Disclosure Index
It will be used to evaluate emotional expression and repression. Our treatments may indirectly have impact on disclosure of the patients' emotions. The Turkish version of Distress Disclosure Index which has good reliability and variability scores has 12 items and rated on a five-point scale (scored 1-5). Higher scores refer higher expression of emotions.
Measured: Baseline measurement before the treatment programs begin (pre-intervention),post-intervention at week 8(after completing eight week intervention), and 1-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start15 Jan 2022
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Cennet Yastıbaş, Dokuz Eylul University
- Investigators
- Cennet Yastıbaş-Kaçar, MD, Study chair, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259267
- Sponsor's protocol ID
- 121K686
- Status last verified
- Feb 2022
- First submitted
- 7 Feb 2022
- Last updated
- 28 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of an Online Group Therapy Program for Post-Traumatic Growth in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT05259267
- Acronym / sponsor ID
- 121K686
- Conditions
- Breast Cancer
- Keywords
- breast cancer, post-traumatic growth, online group therapy, online support groups
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 28 Feb 2022 (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.
Breast cancer is a serious and life-threatening health problem that is increasing all over the world and in Turkey. Although the survival rate increases with the improvement of the diagnosis and treatment processes for breast cancer, cancer patients experience some psychosocial problems both due to their treatment and the disease. Decreases in quality of life, psychological distress, especially depression and anxiety, post-traumatic stress disorder as well as sleep disorders, fatigue, fear of cancer recurrence could be common negative outcomes that experienced by the breast cancer patients. Although, cancer could be such a life-threatening disease, some patients report that they experience positive changes in their lives after the diagnosis of cancer. The concept of Post-Traumatic Growth (PTG) was first developed by Tedeschi and Calhoun (1995). PTG is a concept that refers positive psychological changes after struggling an stressful life event. According to the Functional-Descriptive model of Tedeschi and Calhoun, post-traumatic growth occurs in five areas; relating to others, personal strength, spiritual changes and appreciation of life. In this context, a group intervention program has been developed for PTG, which will bring the person to a better functionality than before the trauma to enhance the Post-Traumatic Growth level of women with breast cancer. The current research project will consist of three arms; therapy group, support group and wait-list. Online group therapy consists of eight sessions that continue approximately 90 minutes. In addition to an active treatment group for PTG, an online support group has been developed by the researchers to investigate the effectiveness of the therapy. Online support group also consists of eight sessions during approximately 90 minutes as in intervention program. Wait-list is considered as a control group. A set of reliable and validated measurement tools will be administered and heart rate variability as a physical measurement will be used to examine the effects of the therapy. The research hypotheses are based on that patients who participated active treatment group will have better PTG level and other related concept with PTG (like higher score of deliberate rumination) and better Heart-Rate Variability scores than other groups. The researcher will plan to take three time measurement: pre-intervention, post-intervention, and 1-month follw-up.
Detailed description
Preliminary studies to development of the programs Before the development of protocol of the current treatment programs, the investigators reviewed related literature and published a systematic review about the related factors for PTG in women with breast cancer. After obtaining the ethical approval the study coordinator interviewed with eight women via telephone to explore the experiences of women with breast cancer. The investigators determined the needs and possible challenges of the illness. Besides, previous similar treatment programs were examined in detail. Later, the investigator developed the study protocol with the supervisor and send the content of the treatment programs to five specialists who have MD in clinical psychology and got feedback and the investigators revisited final version of the treatment programs.
In brief, the research hypotheses are 1) both online group therapy for PTG and online support groups will show better PTG levels and rumination scores, and other secondary measurements (such as psychological distress, heart rate variability, disclosure of distress) than wait-list control. 2) Participants who in online group therapy for PTG will improve better PTG and rumination scores, and secondary measurements' scores compared with the participants in online support groups. 3) The benefits of the treatment programs will be endured for 1-month follow-up measure.
Procedure Ethical approval: This study was approved by the institutional review board of Eskisehir Osmangazi University. All study participants gave written informed consent. Announcements will be posted in various departments of the hospital to participate in the research. First of all, volunteer participants will be assessed through the phone and informed about the research process. If they agree to participate, the investigators will organize a detailed interview. In this interview one of the researchers of the study who is a psychiatrist will apply SCID to eliminate the other possible mental disorder. Patients who meet the criteria will be informed about the group and informed consent forms will be obtained. Before beginning of the treatment program, baseline measurement and ECG Holter measurement will be scheduled by the telephone. After completing baseline measurement, the participants will then be randomly allocated to one of the three groups.
The online treatment programs will be delivered to groups of 6-8 participants by a psychologist and psychiatrist (therapist and co-therapist), eight weekly online sessions. Online sessions will be delivered through an online video-conferencing software (ZOOM). Sample size is determined by g-power analysis. For three-arm randomized controlled trial we plan to recruit at least 51 participants (each group should have at least 17 participants). Before the beginning of the study, the participants will be informed about online video-conferencing platform. The investigators will send a video about the use of platform and also step by step user manual. Each participant in treatment programs should join at least six sessions. If the participants could not complete six sessions, the investigators will admit them drop-out (This information will be declared during the interviews and written informed consent). The investigators will use SPSS 23.0 Package Program for Social Sciences. The descriptive analysis will be performed for frequencies of socio-demographics and clinical information such as cancer stage, treatments. To test the hypothesis, the investigators will conduct a repeated measure ANOVA. The investigators will employ intention to treat and as treated analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Online Group Therapy for PTG | Experimental | Behavioral: Online Group Therapy for PTGIt consists of eight sessions that occur during app. 90 minutes. A group therapist and a cotherapist will lead the therapy sessions. There will be one session per a week. |
| Online Support Group | Active comparator | Behavioral: Online Support GroupIt consists of eight sessions that occur during app. 90 minutes. A group therapist and a cotherapist will lead the therapy sessions without using any psychological methods. There will be one session per a week. |
| Wait-list | No intervention | –We used a wait-list as a control group. After each participants in both online PTG group therapy and online support group completed the interventions, wait-list will be randomly assigned to one of these two interventions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- women who have been diagnosed with breast cancer for the first and only
- women who have been diagnosed breast cancer in 2018 and later (past four years)
- stage I, II and III patients
- ability to use internet
- having a personal computer or tablet with a camera and microphone
Key exclusion criteria (3 listed)
- recurrence of breast cancer,
- second cancer,
- severe psychological or physical comorbidity
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 |
|---|---|---|
| Online Group Therapy for PTGOnline Group Therapy for PTG consists of eight sessions. Each sessions have specific themes. First session: psychoeducation, normalization of the experiences and emotions. Second session: emotion regulation skills. Third session: awareness of the negative thoughts that make patients worried, anxious, feared. Forth session: restructuring of the thoughts and practicing mindfulness technics. 5. session: practicing of self-disclosure skills 6. session: creating a breast cancer story with balancing losses and gains. 7. session: sharing of the effects of breast cancer on life and developing new life priorities 8. session: making life meaning and developing new life goals. | Behavioural | Online Group Therapy for PTG |
| Online Support GroupOnline support groups also consist of eight sessions. 1. session: introducing the program and learning the expectancies 2. session: sharing what is known about breast cancer 3. session: risk and protective factors for breast cancer 4. session: sharing side effects of surgical operation and treatments 5. session: sharing the reactions of family, close friends 6. session: patient-doctor relationship and also sharing the challenges and facilitators of healthcare system 7. session: sharing the current position in the treatment and of what has been done for improvement 8. session: sharing the reliable information sources for breast cancer and close | Behavioural | Online Support Group |
Primary outcome
Change in Post-traumatic Growth Inventory
Time frame: Baseline measurement before the treatment programs begin (pre-intervention),post-intervention at week 8(after completing eight week intervention), and 1-month follow-up.
The Turkish version of Post-traumatic Growth Inventory to measure PTG levels of the patients will be used. It is compromised of 21 item and scored ranging from 0 to 5. Higher scores refer higher PTG level.
Change in Event-Related Rumination Inventory (ERRI)
Time frame: Baseline measurement before the treatment programs begin (pre-intervention),post-intervention at week 8 (after completing eight-week intervention), and 1-month follow-up.
The Turkish version of Event-Related Rumination Inventory (ERRI) that is reliable and validated measure will be used to assess rumination of the breast cancer. It has 20 items and two sub-scale; intrusive and deliberate rumination. The scores are changing from 0 to 3.
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline measurement to deciding to join the treatment programs
It will be used to asses stressful level of breast cancer to participate the treatment programs.The 20-item self-report measure of PTSD scored from 0 to 4, and yielding a scale score range of 0-80.
3 secondary outcomes
Change in Depression Anxiety and Stress Scale (DASS-21)
Time frame: Baseline measurement before the treatment programs begin (pre-intervention),post-intervention at week 8(after completing eight week intervention), and 1-month follow-up.
Change in Heart-Rate Variability
Time frame: Baseline measurement before the treatment programs begin (pre-intervention),post-intervention at week 8(after completing eight week intervention), and 1-month follow-up.
Change in Distress Disclosure Index
Time frame: Baseline measurement before the treatment programs begin (pre-intervention),post-intervention at week 8(after completing eight week intervention), and 1-month follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Cennet Yastıbaş-Kaçar, MD study chair
Dokuz Eylul 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 Online Group Therapy for PTG and Online Support Group in people with Breast Cancer, run by Dokuz Eylul 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cennet Yastıbaş-Kaçar, MD (+905346320490, cennet.yastibas@deu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Post-traumatic Growth Inventory (time frame: Baseline measurement before the treatment programs begin (pre-intervention),post-intervention at week 8(after completing eight week intervention), and 1-month follow-up.). The study lists 3 primary outcomes in all. 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 28 Feb 2022.