Behaviors and Mental Disorders

All Conditions

Depression

Anxiety Disorders

Depressive Disorder

Behavioral Symptoms

In-person baseline surveys using the web-based data collection platform, Research Electronic Data Capture before the random assignment to DS arm. Eight Digital Stories Intervention (4 patient and 4 caregiver stories about hematopoietic stem cell transplantation (HCT) over the course of 4 weeks (2 videos per week) with a weekly email notification and reminder phone call. Each story was made with voice, images, and sound (3-5 minutes each).

In-person baseline surveys using the web-based data collection platform, Research Electronic Data Capture (REDCap) before the random assignment to IC arm. Eight Information Control Intervention videos containing only information about post-HCT care (as opposed to story/narrative) over the course of 4 weeks (2 videos per week) with a weekly email notification and reminder phone call.

Baseline surveys contained a series of scaled questions, including sociodemographic variables (age, sex, cancer type, and etc), profile of mood states, social well-being, emotional processing and acceptance.

Baseline Surveys

Digital Stories Intervention Videos contain the following content: caregiver burden, positive and cognitive coping, support from other family and friends, fear of losing the patient, spirituality, guilt of being sick, and expressing emotions/feelings

Digital Stories Intervention

Information Control Intervention Videos include Information about post-HCT. The topics in the IC include specific guidelines to return to wellness post HCT through (1) an exercise plan, (2) a nutrition (dietary) plan, (3) pain management, (4) information about the complications, (5) caregiver responsibilities, (6) social support, (7) preventing from infections, and (8) symptom management. Participants randomized to the IC will receive the full set of DS modules only after the final 3-month post-intervention data collection point has passed and they can view them as desired.

Information Control Intervention

Sunny Kim, Ph.D

Patients and caregivers undergoing hematopoietic stem cell transplantation often continue to experience anxiety, depression, isolation, and other psychosocial distress. A narrative-based digital stories intervention has shown promise in a pilot study with breast cancer patients in helping to alleviate emotional distress. This study is designed to test digital stories to be viewed and discussed by other HCT patients/caregivers as a psychosocial intervention in a randomized controlled trial and to test the effects of digital stories on how 110 patient and caregiver dyads (N=220) undergoing one of the most rigorous and aggressive treatments cope with treatment-related distress through supportive open dyadic communication and emotional expression.

Patients and caregivers undergoing hematopoietic stem cell transplantation (HCT) are at particular risk for reduced psychological and social well-being due to the rigorous and unique nature of the transplant experience, such as prolonged immunosuppression and multiple post HCT complications resulting in frequent hospitalizations. However, few studies have evaluated interventions to alleviate psychosocial distress for both patients and caregivers, and those have yielded inconclusive results. A narrative-based (storytelling) approach may be an effective intervention tool for HCT patients and caregivers coping with psychosocial distress. The preliminary data show that stories shared by individuals in which a range of emotional expression or resolutions are described, may have beneficial effects on emotional well-being. In a recent pilot study of a 3-day digital storytelling workshop, investigators produced a series of digital videos with narratives from a panel of post-HCT patients. The purpose of this study is to use these digital stories (DS), to be viewed and discussed by HCT patient/caregiver dyads, as a therapeutic intervention and to examine influences on both patients' and caregivers' psychosocial status. This cost-effective, non-invasive, and easy-to-deliver psychosocial support vehicle has never been formally tested as an intervention for HCT patients or patient-caregiver dyads.

To build upon investigators' preliminary studies and to pilot test the efficacy of this series of DS, 110 adult patients undergoing HCT at the Mayo Clinic Arizona and patient respective adult caregivers (N=220 total participants) will be randomized to either (a) an intervention using DS (dyadic exposure to four 5-minute modules) or (b) an information control (IC) video group (dyadic exposure to four videos containing only information about post-HCT care) followed by encouragement to discuss as a dyad. Exposure will occur once per week over 4 weeks via a secure web-based data collection platform (REDcap) with a weekly email notification and reminder phone call. Using investigator's model of Narrative Effects on Socio-Emotional Well-Being, we will also examine expected mediating factors to determine how stories may "work" to reduce psychosocial distress by fostering emotional processing, acceptance, and dyadic disclosure of emotions.

Effects of Digital Stories Intervention on Psychosocial Well-being

Effects of Digital Stories Intervention on Psychosocial Well-being for Cancer Patients and Caregivers Undergoing Hematopoietic Stem Cell Transplantation

Emotional Well-Being (Reduction of Emotional Distress) will be measured using the Profile of Mood States (POMS) short version (15 items, 5-point Likert scale; 0=not at all, 4=extremely). The POMS is one of the most frequently used and validated scales in studies of psychosocial interventions for cancer patients. The POMS Total Mood Disturbance (TMD) score has been shown to be most sensitive to interventions designed to facilitate emotional expression.The POMS consists of the TMD dimensions (tension-anxiety; depression-dejection; anger-hostility; and confusion-bewilderment) (Cronbach's a = .93) to be used in the current study as the primary outcome measure; and two others (fatigue-inertia; vigor-activity) will be documented. Total of Mood Disturbance= (anxious+depression+anger+fatigue)- vigor (Range from 12 to 48). The higher values represent a worse emotional well-being.

The general Functional Assessment of Cancer Therapy (FACT-G) social well-being scale (8 items, 5-point Likert scale (0 = not at all, 4 = very much, Score range: 0-28 \[summed\]). The FACT-G is widely used in clinical trials specifically to measure four areas of quality of life, but only the social well-being (Cronbach's a= .86), dimension will be used in the proposed study. The higher values represent a better social well-being.

Mayo Clinic

National Cancer Institute (NCI)

Arizona State University

In-person baseline surveys using the web-based data collection platform, Research Electronic Data Capture before the random assignment to HRVB+DS arm. This group will receive a standardized HeartMath© Inner balance device and HRV biofeedback training session at the start of the two-week intervention period. They will be asked to attend either a group or one-on-one 30-minute HRVB training session and asked to practice their HRV biofeedback skills at home for 10 minutes each day for a two-week period. Participants will also be asked to watch four digital stories of other HCT patients (2 videos per week) with a weekly email notification and reminder phone call. Each story was made with voice, images, and sound (3-5 minutes each).

In-person baseline surveys using the web-based data collection platform, Research Electronic Data Capture (REDCap) before the random assignment to HRVB waitlist +DS control arm. After the baseline data collection, during two weeks, they will be provided four digital stories of other HCT patients sharing their experiences (challenges, feelings, strategies, coping, each 2-3 minutes long). At the end of the two-week period, participants will be scheduled for a final in-person session including T2 survey and HRV assessment. They will be also provided HRVB training session at T2.

Participants randomized to the intervention arm will receive exactly the same four digital stories via REDCap, a standardized HRV sensor and accompanying smart phone app, and a 30-minute HRVB training to use the biofeedback signals to generate a resonant frequency pattern of HRV (coherence) after collecting data at baseline in person. Participants will be given a take-home manual and specifically asked to practice their HRVB skills at home for 5 minutes prior to viewing stories once each week and upload a log of their time practiced to the cloud. The main purpose of adding HRVB practice as a "priming" experience (i.e., to teach participants to practice HRV prior to viewing stories) is to optimize results by focusing patients' and caregivers' skills and experience on HRV as a mechanism of improved emotion regulation, and then combine this achieved coherent pattern with DS intervention.

Heart rate variability biofeedback

Four Digital Stories Intervention (4 patient stories about hematopoietic cell transplantation (HCT) over the course of 2 weeks (2 videos per week) with a weekly email notification and reminder phone call. Each story was made with voice, images, and sound (3-5 minutes each). The 4 digital stories patients produced contained the following content: (1) a leukemia patient expressed and controlled her depression and anxiety and described how she dealt with the intensive treatment and recovery through a positive attitude and active coping; (2) a mother of 3 children, who was experiencing severe pain due to MS, coped with HCT through family support and positive reframing; (3) a lymphoma patient coped with the HCT procedures by praying during the treatment; and (4) a father of young twins had a HCT twice, and his wife helped him cope with emotional distress through open communication and expressing emotions.Participants will receive a 30-minute HRVB training session at T2.

Heart rate variability waitlist and Digital storytelling Control intervention

Sunny Kim, PhD

Patients undergoing hematopoietic stem cell transplantation (HCT) often continue to experience anxiety, depression, isolation, and other psychosocial distress due to the severe nature of the transplant experience. Storytelling interventions that provide an opportunity for emotional disclosure have shown preliminary efficacy to alleviate psychosocial distress and improve emotion regulation during health challenges. Not only are these changes observed in response to such interventions, but they can also be directly strengthened with HRV biofeedback (HRVB) training, a device-driven breath pacing practice that uses colored light signals to provide feedback to increase vagal tone and improve emotional responses and sleep quality by regulating negative affect and stress. This randomized controlled trial will explore the effects of HRV biofeedback (HRVB) training combined with a digital storytelling intervention and changes in psychosocial distress with a modified waitlist control in a population of Hematopoietic cell transplantation (HCT) patients.

This randomized controlled trial will explore the effects of an HRV biofeedback (HRVB) training session with a modified waitlist control in a population of Hematopoietic cell transplantation (HCT) patients. We will secondarily explore effects of a brief storytelling intervention, with or without the prior HRVB training. Two group of 10 HCT patients over the age of 18 will be recruited and enrolled into the study. The time of participating in this study will be 2-week proposed activities from the time of enrollment to completion. Specific participation will include baseline data collection (about 30 minutes), HRVB training session (30 minutes), watching and discussing stories (15 min for each week= 30 minutes) and one final data collection (about 30 minutes) at the end. For HRVB group, participants will be instructed to practice their HRV biofeedback skills at home for 10 minutes each day for a two-week period (about 140 minutes). Lab visit is required only twice for baseline data collection and final data collection. Other works will be via internet.

The Effects of Heart Rate Variability Biofeedback Training on Hematopoietic Cell Transplantation Patients

Depression will be measured using the Center for Epidemiological Studies Depression Scale Revised (CESD-R-10) scale (10 items, 4-point Likert scale (0 = rarely or none of the time, 3= all of the times, Cronbach's a = .86). The higher values represent a worse depression.

The Emwave Pro Plus device from HeartMath will be used to collect HRV data and heart rate using a 3-minutes "neutral" protocol (we call "waiting at the bus stop" implying that no particular intent for breath or mindful state is to be evoked) to understand the benefits of DS+ HRVB. In addition, HRV measures will be obtained for the 1-minute paced breathing period to understand the effects of paced breathing on HRV. The following precautions will be provided as instructions to participants prior to data collection: no coffee, tea, or caffeinated drinks such as energizing drinks in the 2 hours before the data collection, and no alcohol consumption during 24 hours prior to the data collection.

Psychological distress will be measured using the Profile of Mood States (POMS) short version (15 items, 5-point Likert scale; 0=not at all, 4=extremely). The POMS is one of the most frequently used and validated scales in studies of psychosocial interventions for cancer patients. The POMS Total Mood Disturbance (TMD) score has been shown to be most sensitive to interventions designed to facilitate emotional expression. The POMS consists of the TMD dimensions (tension-anxiety; depression-dejection; anger-hostility; and confusion-bewilderment) (Cronbach's a = .93) to be used in the current study as the primary outcome measure; and two others (fatigue-inertia; vigor-activity) will be documented. Total of Mood Disturbance= (anxious+depression+anger+fatigue)- vigor (Range from 12 to 48). The higher values represent a worse emotional well-being.

HonorHealth Research Institute

Assistant professor

Children's group where digital storytelling method was applied and stories were created

Children's group where the stories of children in the initiative group will be watched

4 stages of digital storytelling will be implemented.

Digital Storytelling

Birgül Erdoğan, Msc

The aim of this clinical study is to evaluate the effectiveness of the digital storytelling method in symptom management in children diagnosed with oncology. It will also provide information about children's experiences with Digital Storytelling and the use of the method. The main questions it aims to answer are:

* Is there a difference between the anxiety scores of children who applied the Digital Storytelling Method and those who did not?
* Is there a difference between the fatigue scores of children who applied the Digital Storytelling Method and those who did not?
* Is there a difference between the nausea scores of children who applied the Digital Storytelling Method and those who did not?
* Is there a difference between the pain scores of children who applied and did not apply the Digital Storytelling Method?

Participants:

Complete the first stage data forms. Visit the clinic every 7-15 days for the digital storytelling process, which consists of 4 stages. After the storytelling process is completed, have a process evaluation meeting with the researcher.

Participants; Enterprise Group,

1. Interview (Week 1); Meeting the child, conducting a qualitative interview for needs analysis and introducing the forms
2. Interview (Week 2); Finding a digital story topic
3. Interview (Week 3); Writing a story on the specified topic
4. Interview (Week 4); Converting the story into digital form
5. Interview (Week 5); Showing the created story
6. Interview (Week 6); Conducting a qualitative interview regarding the digital storytelling process.

Each meeting will be held in 1-week periods. Primary outcome tools will be applied as pretest and posttest once in the 1st and 6th interviews, and twice in the other interviews.

Control Group;

1. Interview (Week 1); Meeting the child, introducing and applying the forms
2. Interview (Week 6); Conducting a qualitative interview regarding the digital storytelling process. Showing the videos prepared by the children in the initiative group. Application of primary outcome tools.

Digital Storytelling in Symptom Management Pediatric Oncology

Evaluation of the Effectiveness of Digital Storytelling Method in Symptom Method in Children With Oncological Problems

It will be used to evaluate children's state anxiety.

It is a single-item scale used to determine the intensity of fatigue in patients. The patient is asked to score his or her fatigue on a scale of 0-10. 0 means no fatigue, while 10 is considered a lot of fatigue.

The scale is applied to children/adolescents in the 7-18 age group. There are a total of six items in the scale, ranging from no force to vomiting, and six facial expressions indicating each item. While the scale can be used by asking the child to choose the face that best suits him/her, the cartoon can also be shown and evaluated through observation. The average application time of the scale is 2 minutes and scores are given between 0-10. Using 0 as 'no nausea' and 10 as 'vomiting'

This scale is used to diagnose pain in children aged 3-18. This scale has six faces representing increasing pain intensity from zero to five from left to right. The far left face has a smiling expression, indicating a pain-free state, while the far right face has a crying expression, corresponding to the most severe pain. Six facial expressions are scored from left to right on a scale of 0 to 10 points (0 points = very happy/no pain, 10 points = most severe pain). As the score from the scale increases, pain tolerance decreases, and as the score decreases, tolerance increases. The child is told to choose the face that best expresses his or her emotions.

The screening tool includes 15 symptoms that evaluate the symptoms children have experienced in the last two days. Each symptom is evaluated with a 5-point Likert-type scoring system, and the score range varies between 0-60. Higher scores indicate that the number of symptoms and the discomfort they cause increase.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Digital Stories Intervention on Psychosocial Well-being	NCT03654599	Bone Marrow Tra... Information Dis... Hematopoietic S... Psychosocial He... Depression Anxiety Stress Narrative	Baseline Survey... Digital Stories... Information Con...	18 Years -	Arizona State University
The Effects of Heart Rate Variability Biofeedback Training on Hematopoietic Cell Transplantation Patients	NCT04275830	Hematopoietic S... Bone Marrow Tra... Heart Rate Vari... Autonomic Nervo... Stress Mood Psychological D... Emotion Regulat... Communication R... Narrative	Baseline Survey... Heart rate vari... Heart rate vari...	18 Years -	Arizona State University
Effects of Digital Stories Intervention on Psychosocial Well-being	NCT03654599	Bone Marrow Tra... Information Dis... Hematopoietic S... Psychosocial He... Depression Anxiety Stress Narrative	Baseline Survey... Digital Stories... Information Con...	18 Years -	Arizona State University
Digital Storytelling in Symptom Management Pediatric Oncology	NCT06436651	Child, Only Cancer Symptoms and Si... Narration	Digital Storyte...	7 Years - 18 Years	Kocaeli University

Spots Global Cancer Trial Database for digital storytelling