Behaviors and Mental Disorders

All Conditions

Rare Diseases

Anxiety Disorders

Depressive Disorder

Depression

Behavioral Symptoms

Chronic Graft Versus Host Disease

The Sophie Cognitive Behavioral Therapy (CBT) intervention is a tablet-based computerized CBT and self-management education intervention that consists of an evidence-based cognitive behavioral therapy self-management curriculum divided into 6 discrete modules. Patients will have up to 8 weeks to work through the modules on the tablet.

iHope CBT is a telemedically-delivered CBT package. The iHope system comprises a HIPAA-compliant platform on which real, live, licensed clinicians provide cognitive behavioral therapy via video conferencing, phone calls, and text messaging. iHope will be delivered on subjects' preferred electronic device (mobile phone, laptop, tablet).

The Sophie CBT system is a tablet-based system that delivers self-paced cognitive behavioral therapy educational curriculum in the format of 6 discrete modules.

Sophie CBT System

Licensed therapists will use the iHope HIPAA-compliant telemedicine platform to deliver cognitive behavioral therapy to patients via telephone, videoconferencing, and/or text chat.

iHope CBT

Suzanne Mitchell, MD

Evidence-based interventions using cognitive behavioral therapy (CBT) and self-management education have been demonstrated to effectively treat symptoms of depression and improve the quality of life in populations with chronic illness. Research indicates that CBT is the most effective psychosocial treatment for depression; as effective as pharmacotherapy and as effective as adding another medication for patients who do not respond to one antidepressant alone. Despite the existence of proven efficacious treatments for depression, however, fewer than half of patients for whom depression treatment is indicated receive the services they need. Access barriers (i.e., transportation, insurance coverage), limited clinician availability (i.e., long waitlists, difficulty finding a provider), and competing (and time-consuming) medical priorities contribute to inadequate depression treatment for individuals with serious chronic illness. In this research the investigators will conduct a pilot randomized trial to compare results from implementation of two CBT strategies iHope and Sophie.

A pre-implementation pilot study will be conducted with 20 adult patients diagnosed with advanced (Stage 3 or 4) cancer who screen positive for moderate depression and are receiving care at the Solomont Center for Hematology and Medical Oncology at Boston Medical Center (BMC) with the following specific aims:

1. Using the Consolidated Framework for Implementation Research (CFIR) as a guide, design a pilot implementation strategy for introducing the Sophie CBT system and iHope system into the clinical context of care (Months 1-4)
2. Conduct a pre-implementation pilot study with randomization of 20 cancer patients who screen positive for depression and/or anxiety into two arms with Sophie CBT or iHope telemedicine (10 participants each) to: a) assess the feasibility, acceptability, and appropriateness of implementing the Sophie CBT and iHope interventions in an ambulatory cancer treatment center and b) evaluate the potential impact of the Sophie CBT and iHope interventions on measures of depression, anxiety, coping, and quality of life for cancer patients with comorbid depression (Months 5-10)

Sophie Pilot Implementation and Assessment

Comparing the Sophie RA-CBT System and Telemedically-delivered CBT: a Pilot Implementation Study

Changes in depressive symptoms will be measured using the PHQ-8, which is an 8-item scale with scores ranging from 0 to 24, with higher scores indicative of more depressive symptoms

The Generalized Anxiety Disorder 7 (GAD-7) will be used to assess changes in anxiety. The GAD-7 is a 7-item questionnaire that asks how often an individual has been bothered by a given item over the last 2 weeks. Scores range from 0 ("not at all") to 3 ("nearly every day.") A higher overall score indicates a greater level of anxiety.

Changes in coping will be assessed using the Ways of Coping scale which is a 66 item scale with potential responses from 1 to 4, with higher scores indicative of more frequent use of a particular strategy.

Changes in quality of life will be assessed using the Quality of Life Scale (QOLS), which is a 15-item scale with potential responses ranging from 1 to 7, with higher scores indicating a higher level of satisfaction with quality of life.

Boston Medical Center

The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 60 minutes

Mindfulness-Based Cognitive Therapy (MBCT)

The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 60 minutes.

Cognitive Behavioral Therapy (CBT)

Annika Tovote, Dr.

Maya Schroevers, Dr.

The purpose of this study is to determine whether mindfulness-based cognitive therapy (MBCT) and cognitive behavioral therapy (CBT) are effective in reducing depressive symptoms in patients after cancer

Cancer patients are prone to develop depressive symptoms, even after curative treatment. Conventional therapies such as cognitive behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT) are frequently used for reducing these depressive symptoms in patients with medical conditions. However, until now evidence from proper designed randomized controlled trials regarding the effectiveness of both interventions in cancer survivors, is lacking. Therefore, our longitudinal study aims to investigate the effectiveness of CBT and MBCT in reducing depressive symptoms in cancer survivors. In addition, potential moderators and mediators of each intervention will be explored.

MBCT and CBT for Depression in Patients After Cancer: a Randomized Controlled Trial

Individual Mindfulness-Based Cognitive Therapy (MBCT) and Individual Cognitive Behavioral Therapy (CBT) for Depression in Patients After Cancer: a Randomized Controlled Trial

Severity of depressive symptoms will be assessed with the Beck Depression Inventory-II (BDI-II)

Generalized anxiety is measured by the Generalised Anxiety Disorder Assessment (GAD 7)

Well-being is measured by the WHO Well-being Index (WHO-5)

Fear of recurrence will be measured by Concerns About Recurrence Scale (CARS)

Fatigue is measured by the subsequent scale of the Multidimensional Fatigue Inventory (MFI-20)

University of Groningen

Dutch Cancer Society

University Medical Center Groningen

Dr. M. Schroevers

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Fatigue

Prostatic Neoplasms

Chronic Disease

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Central Nervous System Stimulants

Cardiotonic Agents

Androgens

Methylphenidate

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

Placebo capsules by mouth twice daily. Participants in sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.

Methylphenidate starting dose 5 mg by mouth twice daily. Participants in sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.

Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Placebo capsules by mouth twice daily.

Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill. Placebo capsules by mouth twice daily.

Methylphenidate starting dose 5 mg by mouth twice daily. Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist.

Methylphenidate starting dose 5 mg by mouth twice daily. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.

Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill. Placebo capsules by mouth twice daily

Methylphenidate starting dose 5 mg by mouth twice daily. Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist. Cognitive Therapy - 8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.

Placebo

8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each.

Counseling Sessions

Participants in placebo/sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.

Sham Exercise

Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist.

Standardized Exercise Intervention Program

8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.

Sriram Yennurajalingam, MD

The goal of this clinical research study is to learn about the effect of different combinations of exercise, supportive counseling, and methylphenidate/placebo for the treatment of fatigue in patients with prostate cancer. The safety of this treatment combination will also be studied.

Methylphenidate is a stimulant designed to increase the activity of the central nervous system.

A placebo is not a drug. It looks like the study drug but is not designed to treat any symptom, disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

The exercise in this study is designed to help improve your physical fitness and energy levels.

Supportive counseling is designed to help to control symptoms, fatigue, anxiety, depression, pain, and/or sleep disorders.

If you are found eligible and agree to take part in the study:

* You will complete a baseline exercise assessment which will last about 30-45 minutes and include the following:
* A sit-to-stand test. You will sit in chair with your arms across your chest. Then you will be timed as you stand and sit down 5 times as quickly as possible.
* A hand-grip strength test. You will grip a device with each hand as hard as you can.
* A 6-minute walk test. You will be timed while you walk on a 100-foot loop. You will walk 50 feet and then turn and walk back to the beginning. You will do this at a walking speed that feels comfortable and for as many times as you can in 6 minutes.
* You will be given a belt (accelerometer) that you are required to wear for the first week of treatment. The accelerometer measures your physical activity.

Study Groups:

You will be randomly assigned (as in the roll of dice) to 1 of 8 study groups. You will have an equal chance of being assigned to any group. You will have a 50% chance of receiving the placebo.

The exercises and skills learned during counseling will be different for each study group. The study staff will talk to you about your assigned exercises and skills. You will be assigned to 1 of 2 types of exercise groups. One group will do resistance exercises and walking, and the other group will do stretching.

You be assigned to 1 of 2 types of counselling groups. One group will receive education on relaxation and symptoms. The other group will receive standard supportive counseling.

Neither you nor the medical study staff will know which group you are in. Only the study staff who will work with you for the exercise and counseling will know which group you are in. If needed for your safety, the medical staff will be able to find out which group you are in.

Study Drug/Placebo Administration:

You will take the methylphenidate/placebo capsules by mouth with water, 2 times each day. You must take both doses before 3 PM and wait at least 2 hours between doses.

Study Visits:

For all study visits/calls, you will be asked about any drugs you may be taking or any side effects that you may be having. At home during the study, you will continue practicing exercises from the exercise sessions and skills from the counseling sessions.

On Day 1, if not done at Screening:

* Your medical history will be recorded.
* You will have a physical exam, including measurement of your vital signs.
* You will complete 5 questionnaires, which should last about 30 minutes. The questionnaires ask about:
* Your emotional and physical well being
* Your level of fatigue
* Any anxiety and/or depression you may be having
* Any symptoms you may be having

On Day 8 (+/- 3 days):

* You will meet with a counselor. You will be asked to discuss your thoughts and feelings on different topics related to your well-being. The counseling session will last about 45 minutes.
* You will meet with the exercise trainer. The exercise trainer will teach you exercises and give you written instructions for how to do them at home. The exercise meeting will last about 30-45 minutes.
* You will be asked to complete a questionnaire that asks about any symptoms and/or side effects that you may be having. This should take about 10 minutes.

On Days 15 and 29 (+/- 3 days):

* You will exercise and then be asked how the exercises are going either in person or later over the phone. This should last about 30 minutes.
* You will have a counseling session with a counselor over the phone. This should last about 45 minutes.
* You will complete the 5 questionnaires.

On Days 22 and 36 (+/- 3 days) the exercise trainer and the counselor will call. These calls should last between 30-45 minutes.

On Day 43 (+/- 3 days) the exercise trainer and the counselor will call. These calls should last between 30-45 minutes.

-You will complete a questionnaire that asks about any symptoms and/or side effects you may be having. This should take about 10 minutes.

On Day 50 (+/- 3 days) the exercise trainer and the counselor will call if you have any uncompleted sessions. These calls should last between 30-45 minutes.

-You will be given an accelerometer that you are required to wear for the last week of treatment.

On Day 57 (+/- 10 days) you will return to the clinic:

* You will have a physical exam, including measurement of your vital signs.
* You will complete a sit-to-stand test.
* You will complete a hand-grip strength test.
* You will complete a 6-minute walk test.
* You will complete the 5 questionnaires.

Length of Study Participation:

You may continue taking the study drug/placebo for up to 57 days (+/- 10 days). You will no longer be able to take the study drug/placebo if the disease gets worse, if intolerable side effects occur, if you are unable to follow study directions, or if you cannot complete enough of the treatment combination as planned.

Your participation on the study will be over after you have completed the follow-up visit.

Follow-Up Visit:

About 3 months after your last dose of study drug/placebo, you will return to the clinic for a follow-up visit:

* You will be asked about any side effects you may have had.
* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.
* You will complete a sit-to-stand test.
* You will complete hand-grip strength tests.
* You will complete a 6-minute walk test.
* You will be asked to complete the 5 questionnaires.

This is an investigational study. Methylphenidate tablets are FDA approved and commercially available for the treatment of attention deficit disorder (ADD). The methylphenidate capsules made from the methylphenidate tablets especially for this study are not approved by the FDA. The combination of methylphenidate, exercise, and counseling is considered investigational.

Up to 175 patients will take part in this study. All will be enrolled at MD Anderson.

Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy

Effects of various treatments\[exercise, Cognitive Behavioral Therapy (CBT), Methylphenidate\] and combinations of treatments in Multimodal Therapy (MMT) in reducing cancer-related fatigue in participants with prostate cancer receiving radiotherapy (RT), as measured by change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale scores taken at baseline and on Day 57.

American Cancer Society, Inc.

M.D. Anderson Cancer Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Patients in the Exercise group will follow a fully-supervised exercise routine (Reduced-exertion, high-intensity interval training (REHIT)) with 3 weekly 10-minute training sessions consisting of easy cycling interspersed with 2 brief 'all-out' cycle sprints. Patients in this group will also be offered up to 6 sessions of cognitive behavioral therapy. The duration of the intervention will be the weeks between enrolling in the study and surgery (\~1-4 weeks), as well as an additional period of up to 6 weeks following surgery.

Patients allocated to the Standard Care group will receive the care they would have also received if they would not have participated in the study. They will however undergo the same testing sessions as patients in the Exercise group.

Reduced-exertion, high-intensity interval training (REHIT)

Up to six 30/40-minute sessions of face-to-face psychotherapy will be offered based on a cognitive model of adjustment to cancer utilizing cognitive and behavioral therapy techniques as described by Moorey \& Greer (2012)

Cognitive behavioral therapy (CBT)

Niels BJ Vollaard, PhD

Treatment of cancer patients should not only involve removing the cancer, but should also focus on maintaining good health and well-being and quality of life. This can be done by offering patients suitable rehabilitation programmes. Previous research has shown that such programmes need to involve exercise alongside other components, such as psychological support. To date most studies have looked at the positive effects of moderate-intensity exercise such as brisk walking, but this type of exercise is time-consuming and often not done by many patients. Shorter-duration exercise routines consisting of repeated short sprints have been found to improve general health just as well, but one of the most time-efficient routines (termed 'reduced-exertion high-intensity interval training', or 'REHIT') has not been studied in cancer patients. REHIT involves 3 exercise sessions per week, each only 10 minutes long. This makes it an ideal routine to combine with other components of a cancer rehabilitation programme. The present study will determine whether REHIT can improve important markers of health and well-being in newly diagnosed breast cancer patients. To achieve this the investigators will recruit up to 30 patients and divide them into a group who will do REHIT before and for up to 6 weeks after their cancer surgery, and a control group who will receive standard care. Markers of health and well-being will be measured at the start of the study, \~1 week after surgery, and \~7 weeks after surgery. Any changes will be compared between the exercise group and the control group. If beneficial effects are found with the REHIT intervention then this could be more widely implemented as part of cancer treatment. This study is funded by Nuffield Health and will be performed in Oxford, UK.

This study involves a randomised controlled trial: study participants will be randomly allocated to either a group who will receive the care that they would normally have received if they would not have been in the study (control group), and a group who will receive the same standard care but will also be asked to follow a novel supervised exercise routine three times per week before their surgery and for up to 6 weeks after surgery, as well as some psychological support.

Up to 30 newly-diagnosed female breast cancer patients will be recruited. Following written informed consent, participants will be invited for a baseline testing session. This will involve a fasting blood sample (ideally at a time when the patient's medical team would take a blood sample anyway). The investigators will analyse this sample for a number of markers of health, such as blood sugar and fat levels, and markers of inflammation. The investigators will measure the patients' height with a stadiometer, and weight and body fat percentage using a special set of scales. The investigators will ask patients to complete several questionnaires that ask questions about their current well-being. Finally the investigators will measure the patients' handgrip strength as well as their fitness levels. The grip strength test involves squeezing a handheld device as hard as possible for a few seconds. The fitness test involves cycling on a stationary bike with a gradually increasing resistance until the patient cannot continue any longer because of fatigue. In this test the investigators will ask patients to breathe through a tube to determine the maximal amount of oxygen they can take up during exercise. This measure (termed VO2max) is one of the best health markers that can be measured: it is the best predictor of future risk of chronic disease or premature death. All testing sessions will be performed at the Manor Hospital in Oxford (unless the equipment required for the analysis of VO2max is not available for a period of time, in which case patients will be invited to attend Oxford Brookes campus for the fitness test; this is a 4-minute drive from the Manor Hospital).

Ideally, the blood samples will be taken in a fasted state (i.e. in the morning without having had breakfast), whereas the fitness test will be done after the patient has last had some food. The investigators will therefore provide the participants with a light snack after the blood sample has been taken. In case a patient cannot attend the hospital in the morning in a fasted state then they will arrange the session at a later time of day and the patient will not be required to be fasted (leading to loss of some of the secondary outcome measures which require a fasted state).

After the baseline testing has been completed the investigators will tell patients whether they will be in the control group or in the exercise group. Patients in the control group will receive their standard care as if they would not have participated in the study. The research team will not interact with these patients until the second testing session. Patients in the exercise group will be invited to perform 3 fully supervised exercise sessions per week at the Manor Hospital. These exercise sessions will involve 10 minutes of cycling at a low intensity, but with 2 brief cycle sprints after 2 and 6 minutes. The sprints will last 10 seconds in the first week of training, 15 seconds in the second week, and 20 seconds from week 3 onward. Training sessions will be stopped at least 2 days prior to the scheduled surgery date.

Surgery will interrupt the exercise programme. Between 7 and 10 days post-surgery, or when the consultant breast surgeon deems appropriate, all patients will undergo post-surgery testing. Testing procedures will be identical as those for baseline testing.

Following post-surgery testing, patients in the exercise group will resume the exercise programme. The duration of the sprints will restart at 10 seconds in the first week, 15 seconds in the second week, and 20 seconds in the remaining weeks. The exercise routine will be continued until follow-up treatment or for a period of up to 6 weeks. Before or after one of the 3 weekly exercise sessions, patients will receive a 30/40-minute face-to-face session with a psychologist. The aim of these sessions will be to reduce emotional distress, improve mental adjustment, promote a sense of personal control over current experience, develop effective coping strategies for dealing with cancer-related difficulties, and open expression of emotion. If patients cannot attend psychological support sessions then they will be offered the opportunity to catch up through a session over the phone.

Approximately 3 days following the final training session patients will undergo end-of-trial testing, identical to the previous two testing sessions. Patients in the control group will undergo this testing session at a time-point equivalent to that of patients in the exercise group.

Health Benefits of HIT for Breast Cancer Patients

The Efficacy of Reduced-exertion High-intensity Interval Training for Improving Health and Well-being in Newly Diagnosed Female Breast Cancer Patients

This is a small study which will generate pilot data for larger trials. Although the investigators will publish group data there is no plan to share individual data with other researchers. However, any requests for anonymised individual data will be considered on a case-by-case basis.

VO2max is a measure of the maximal amount of exercise that can be consumed and used during exercise. It is one of the best predictors of future risk of morbidity and mortality. An increase in VO2max represents a positive change in health. The primary outcome measure is change in VO2max from baseline to 1 week post-surgery and 7 weeks post-surgery.

HOMA-IR is a measure of risk of type 2 diabetes and metabolic disease.

This includes circulating levels of total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides. These are common health markers.

Blood pressure is a common health marker.

Height and weight will be measured to calculate BMI (in kg/m\^2). BMI is a common health marker.

Maximal isometric grip strength assesses how hard a person can squeeze their fist. This is a good marker of risk of future morbidity.

Questionnaires will be used to determine changes in mental well-being.

Body fat percentage (as determined using bioimpedance scales) is a common health measure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sophie Pilot Implementation and Assessment	NCT03904342	Depression Chro... Advanced Cancer Anxiety	Sophie CBT Syst... iHope CBT	18 Years -	Boston Medical Center
MBCT and CBT for Depression in Patients After Cancer: a Randomized Controlled Trial	NCT02619916	Depressive Symp...	Mindfulness-Bas... Cognitive Behav...	18 Years - 75 Years	University Medical Center Groningen
Multimodal Therapy for the Treatment of Fatigue in Patients With Prostate Cancer Receiving Radiotherapy With Androgen Deprivation Therapy	NCT01410942	Prostate Cancer	Placebo Methylphenidate Counseling Sess... Sham Exercise Standardized Ex... Cognitive Behav...	18 Years -	M.D. Anderson Cancer Center
Health Benefits of HIT for Breast Cancer Patients	NCT03176888	Breast Cancer	Reduced-exertio... Cognitive behav...	35 Years - 60 Years	University of Stirling
MBCT and CBT for Depression in Patients After Cancer: a Randomized Controlled Trial	NCT02619916	Depressive Symp...	Mindfulness-Bas... Cognitive Behav...	18 Years - 75 Years	University Medical Center Groningen

Spots Global Cancer Trial Database for cognitive behavioral therapy (cbt)