Improving Emotion Regulation at the End of Breast Cancer Treatment
NCT ID: NCT03336827
Last Updated: 2020-12-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-01-01
Study Completion Date
2020-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The end of treatment marks the beginning of a challenging period for breast cancer patients. While this period often provokes a sense of relief, it can also be a source of apprehension and vulnerability regarding the future. Patients may be brought to feel contradictory thoughts and emotions impacting their quality of life such as anxiety linked to uncertainty and fear of cancer recurrence. In order to accompany breast cancer patients during this transition period and to address these emotional difficulties, the Institut Jules Bordet has launched an 8-session psychological multi-component group intervention. Its objective is to bring patients tools and competencies (e.g., hypnosis, treatment of intrusive thoughts, learning to cope with uncertainty, attention reorientation toward positive thoughts) to promote emotion management and well-being.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Introduction
At the end of treatment, breast cancer patients are confronted with the short- and long-term physical (e.g., fatigue, pain, hot flashes) and psychological (e.g., anxiety, fear of recurrence, depressive symptoms) consequences of cancer diagnosis and treatment (Costanzo et al., 2007 ; Stanton et al., 2005). Emotion dysregulation (e.g., anxiety, fear of recurrence (Devine \& Westlake,1995), depressive symptoms (Stanton, 2006)) is, with fatigue (Jacobsen \& Jim, 2008) and cognitive dysfunctions (Duijts et al., 2011), one of the three most common complaints. Nevertheless, few psychological interventions have focused on this period (Jacobsen \& Jim, 2008 ; Stanton et al., 2005 ; Stanton, 2006) and no intervention has specifically addressed emotion regulation of breast cancer survivors (Devine \& Westlake, 1995 ; Duijts et al., 2011 ; Sheard \& Maguire, 1999).
Little is known about the required components of psychological interventions designed to support patients facing these challenges. Meta-analyses (Naaman et al., 2009 ; Osborn, 2006 ; Sheard \& Maguire, 1999) and one review (Traeger et al., 2012) have described various components of interventions used to address anxiety and depressive symptoms in cancer care, such as mindfulness (Lengacher et al., 2009 ; Würtzen et al., 2013), education (Björneklett et al., 2012 ; Dolbeault et al., 2009 ; Duijts et al., 2011 ; Fors et al., 2011 ; Osborn, 2006 ; Scheier et al., 2005), cognitive-behavioral therapy (Dolbeault et al., 2009 ; Duijts et al., 2012 ; Fors et al., 2011 ; Osborn, 2006 ; Savard et al., 2005 ; Savard et al., 2005), support groups (Björneklett et al., 2012 ; Fors et al., 2011 ; Montazeri et al., 2001), and relaxation training (Björneklett et al., 2012 ; Elsesser, Van Berkel \& Sartory, 1994 ; Hidderley \& Holt, 2004). These interventions taken individually presented moderate effect sizes (Naaman et al., 2009), suggesting the need to combine components.
During the last four years, our team conducted a study designed to compare the benefits in terms of emotion regulation of a 15-session single-component group intervention (SGI) based only on support with those of a 15-session multi-component group intervention (MGI) combining support with cognitive-behavioral and hypnosis components. The cognitive-behavioral therapy (CBT) components were chosen because interventions using such components have shown larger effect sizes than interventions using other components in previous studies on the treatment of anxiety-related conditions (Chambless \& Ollendick, 2001 ; Deacon \& Abramowitz, 2004 ; Norton \& Price, 2007 ; Osborn, 2006 ; Stewart \& Chambless, 2009). The hypnosis component was chosen because some reviews have suggested that self-hypnosis training is a rapid, cost-effective, and safe alternative to medication for the treatment of such conditions. Moreover, a meta-analysis showed that the addition of hypnosis to cognitive-behavioral component enhances effect sizes of interventions (Kirsch, Montgomery \& Sapirstein, 1995) . Results of this study have shown the acceptability of such an intervention after active treatment (Merckaert et al., 2015). They have also indicated that an MGI combining support with CBT and hypnosis is clinically useful for patients with breast cancer after radiotherapy. Our results confirm the need to design specific interventions targeting anxiety regulation, fear of recurrence, and depressive symptoms. They also underline the necessity of intensifying interventions through including other components (e.g., emotion regulation, repetitive exposures to fear, treatment of intrusive thoughts, attention reorientation).
2. Objectives of the study
The primary aims of this study are to evaluate in a randomized controlled trial (RCT) the efficacy of an 8-session multi-component group intervention extended over 4 months in promoting emotion regulation (in an emotion regulation task and in everyday life) and patient emotional well-being compared with a waiting-list control group. The secondary aims are to evaluate patients' satisfaction with the program, hypnosis/relaxation practice in everyday life, mental adjustment, and changes in patients' level of attentional bias toward cancer threat and physical activity.
3. Participants
Patients who have been treated for a non-metastatic breast cancer will be approached at the end of active cancer treatment (i.e., surgery, chemotherapy, and radiotherapy) in order to be screened for emotion dysregulation. Patients experiencing moderate to high emotion dysregulation (one to four scores = or \> 4 on a 11-point Likert adapted Edmonton symptoms evaluation scale assessing anxiety, fear of recurrence, depression, and intrusive thoughts) will be offered the intervention.
4. Intervention
4.1. Theoretical framework
This is a multi-component group intervention integrating an emotion regulation and an exposure to fear component.
4.1.1. The emotion regulation component builds upon the Adaptive Coping with Emotions Model which was developed to provide a conceptualization of adaptive emotion regulation. It aims to help patients to better identify their physical, emotional and behavioral responses to their positive and negative emotions in order to be able to better regulate or acknowledge those emotions. This component integrates a self-regulation component. The self-regulation component relies on a phone app-based coaching intervention aiming at promoting changes in patients' ability to regulate their emotions in their everyday life. It aims at promoting patients' self-awareness of their internal states, orientating their attention consciously toward positive stimuli and at developing physical activity. Hypnosis is used as hetero-hypnosis in each session and aims at deepening the development of patients' emotion regulation skills. Recordings of the exercises done in session are transmitted to the patients in order to promote use of the technique at home. Helping patients develop autohypnosis skills is important as it may allow them to better regulate their emotions in everyday life.
4.1.2. The exposure to fear component aims at helping patients deal with their fear of death. Just as anxiety is a normal emotion, anxiety concerning death is also a normal experience. The modest level of death anxiety that most people experience in everyday life may increase dramatically when one experiences a period of health problems, illness, or death of someone close (Kastenbaum, 2000). This part of the intervention will be based on worry exposure. This part of the intervention targets cancer-related worry and is based on Borkovec's avoidance theory of worry (Borkovec et al., 1998). Worry is a predominantly cognitive-verbal activity that inhibits full emotional processing. As a result, disturbing emotional meanings of potentially dangerous and anxiously anticipated events cannot be fully tested or altered, making the repetitive processing of the feared stimuli probable (Foa \& Kozak, 1986). Given that cancer-recurrence related-worry is typically characterized by the focus on one hypothetical future event, it follows that exposure with imagined stimuli could be a crucial component of the treatment of fear of recurrence. The intervention will be based on two exercises. In the first, patients will be accompanied through a hypnosis based exposure to a major trigger of fear of recurrence that is the anticipation of the cancer check-up. This exercise is designed to help patients experience the emotions which may arise in this context while being guided through their resolution and regulation. The second exercise aims at helping them overcome their fear of recurrence through discussing their worst-case scenario in the group. The scenario are then discussed in order to highlight which part of them could be modified because it is unrealistic or because patients have more resources than they anticipate.
4.2. Study design and assessment schedule
This is a two-armed, randomized, waiting-list controlled trial. Patients who agree to participate will be randomly assigned to two groups: 1) the experimental group (EG) where six patients will receive one individual pre-group session and 8 sessions of group intervention combining cognitive-behavioral therapy and hypnosis; and 2) the waiting-list control group (CG) where six patients will receive the same intervention 4 months later. Patients will be assessed at three time points: 1) at baseline (T1), 2) 4 months later (T2), that means just after the intervention for the experimental group (EG) and just before the intervention for the control group (CG), and 3) 4 months later (T3), that means 4 months after the T2 for the experimental group and just after the intervention for the control group (CG).
4.2.1. Pre-assessment screening
Before inclusion in the study, during the last weeks of treatment (T0), approached patients will complete a socio-demographic questionnaire, a screening of life habits and difficulties questionnaire, an adapted Edmonton symptom evaluation scale (Chang, Hwang \& Feuerman, 2000) (assessing pain, fatigue, sleep disturbances, fatigue, difficulty concentrating, memory loss, feeling of malaise, hot flashes, depression, anxiety, fear of recurrence, and worry), the Hospital anxiety and depression scale (HADS) (Zigmond \& Snaith, 1983), and the Fear of Cancer Recurrence Inventory Severity sub-scale (Simard \& Savard, 2009). Patients will report medical information about their disease, previous and current treatment and prognosis. This screening allows checking for inclusion and exclusion criteria and comparing patients who accept and refuse the intervention.
4.2.2. Assessment procedure
Each assessment procedure (i.e., T1, T2, T3) includes three parts: an emotion regulation task, an ecological momentary assessment and an attentional bias task. Two months after T1 and T2, the experimental (EG) and control (CG) groups will be contacted once by phone to complete a phone-based questionnaire to assess their usual care use.
4.2.2.1. Emotion regulation task
This assessment procedure has been used in a previous project and provides a dynamic picture of patients' emotion regulation. Each assessment session will first involve completion of questionnaires and two emotion regulation exercises: (1) 4 min exposure to anxiety triggers through completion of the Mental Adjustment to Cancer Scale (Watson et al., 1988), followed by a 12-min self-relaxation exercise in which patients will be asked to relax by using their own strategies; and (2) 4 min exposure to anxiety triggers through completion of the Impact of Cancer Questionnaire (Zebrack et al., 2006), followed by a 12-min guided hypnosis exercise in which patients will be asked to listen to an audio recording of a hypnotic induction script. The subtasks will be separated by a period of questionnaires completion. Patients' emotion regulation will be measured physiologically (heart rate measurement) and psychologically (anxiety, sadness, fear of recurrence and energy state-levels).
4.2.2.2. Ecological momentary assessment (EMA)
Patients' emotion regulation in their everyday life will be assessed during 9 days through an ecological momentary assessment (EMA) procedure. Firstly, patients will be asked 5 times a day to select on a list of 20 emotions the 2 or 3 that they were experiencing during the minutes before they saw the notification. For each emotion experienced, they will have to report its intensity on a 10-point Likert scale ranging from 1 to 10. They will have to report to what extent they have felt able to control those emotions and have felt submerged by those emotions. They will report whether during those minutes they had been thinking about something other than what they were currently doing. They will have to answer with one of four options: no; yes, something pleasant; yes, something neutral; or yes, something unpleasant (Killingsworth \& Gilbert, 2010). Finally, they will be asked their level of fatigue and energy. Prompts will be sent randomly from 9 AM to 7,5 PM through the use of the software from http://www.lifedatacorp.com/. Secondly, each evening for 9 consecutive days, patients will have to indicate on the same list of 20 emotions (10 positive and 10 negative emotions), the extent to which they have felt each of the 20 emotions in the past 24 hours and their level of fatigue, from 0 (not at all) to 4 (extremely) (Fredrickson et al., 2003). In order to insure confidentiality, subjects will be provided with an iPod Touch. The two first days of data collection will be used as a training for participants and only their responses on the 7 following days will be taken into consideration. Thirdly, patients will be provided with an armband to continuously record during those 9 days, their heart rate levels, physical activity levels (pedometer and accelerometer) and sleep patterns (Garmin vívoactive HR).
4.2.2.3. Attentional bias task
Patients will complete an attentional bias computer task assessing attentional orientation toward emotional information. An adaptive function of biased attentional orientation toward negative information is to facilitate detection of danger in the environment and to help the organism respond effectively to threatening situations (Bar-Haim et al., 2007). When anxiety symptoms become excessive, biased attentional orientation toward negative information may have detrimental effects on patients' cognitive (e.g., intrusive thoughts, misinterpretation), behavioral (e.g., body screening, future planning difficulties), emotional (e.g., negative affects, panic attacks), and physiological status (e.g., physiological stress activation), and may play a prominent role in the etiology and maintenance of anxiety disorders (Bar-Haim et al., 2007). Computer tasks have been used to study the threat-related attentional bias in anxiety.
At the end of treatment, breast cancer patients are confronted with the short- and long-term physical (e.g., fatigue, pain, hot flashes) and psychological (e.g., anxiety, fear of recurrence, depressive symptoms) consequences of cancer diagnosis and treatment (Costanzo et al., 2007 ; Stanton et al., 2005). Emotion dysregulation (e.g., anxiety, fear of recurrence (Devine \& Westlake,1995), depressive symptoms (Stanton, 2006)) is, with fatigue (Jacobsen \& Jim, 2008) and cognitive dysfunctions (Duijts et al., 2011), one of the three most common complaints. Nevertheless, few psychological interventions have focused on this period (Jacobsen \& Jim, 2008 ; Stanton et al., 2005 ; Stanton, 2006) and no intervention has specifically addressed emotion regulation of breast cancer survivors (Devine \& Westlake, 1995 ; Duijts et al., 2011 ; Sheard \& Maguire, 1999).
Little is known about the required components of psychological interventions designed to support patients facing these challenges. Meta-analyses (Naaman et al., 2009 ; Osborn, 2006 ; Sheard \& Maguire, 1999) and one review (Traeger et al., 2012) have described various components of interventions used to address anxiety and depressive symptoms in cancer care, such as mindfulness (Lengacher et al., 2009 ; Würtzen et al., 2013), education (Björneklett et al., 2012 ; Dolbeault et al., 2009 ; Duijts et al., 2011 ; Fors et al., 2011 ; Osborn, 2006 ; Scheier et al., 2005), cognitive-behavioral therapy (Dolbeault et al., 2009 ; Duijts et al., 2012 ; Fors et al., 2011 ; Osborn, 2006 ; Savard et al., 2005 ; Savard et al., 2005), support groups (Björneklett et al., 2012 ; Fors et al., 2011 ; Montazeri et al., 2001), and relaxation training (Björneklett et al., 2012 ; Elsesser, Van Berkel \& Sartory, 1994 ; Hidderley \& Holt, 2004). These interventions taken individually presented moderate effect sizes (Naaman et al., 2009), suggesting the need to combine components.
During the last four years, our team conducted a study designed to compare the benefits in terms of emotion regulation of a 15-session single-component group intervention (SGI) based only on support with those of a 15-session multi-component group intervention (MGI) combining support with cognitive-behavioral and hypnosis components. The cognitive-behavioral therapy (CBT) components were chosen because interventions using such components have shown larger effect sizes than interventions using other components in previous studies on the treatment of anxiety-related conditions (Chambless \& Ollendick, 2001 ; Deacon \& Abramowitz, 2004 ; Norton \& Price, 2007 ; Osborn, 2006 ; Stewart \& Chambless, 2009). The hypnosis component was chosen because some reviews have suggested that self-hypnosis training is a rapid, cost-effective, and safe alternative to medication for the treatment of such conditions. Moreover, a meta-analysis showed that the addition of hypnosis to cognitive-behavioral component enhances effect sizes of interventions (Kirsch, Montgomery \& Sapirstein, 1995) . Results of this study have shown the acceptability of such an intervention after active treatment (Merckaert et al., 2015). They have also indicated that an MGI combining support with CBT and hypnosis is clinically useful for patients with breast cancer after radiotherapy. Our results confirm the need to design specific interventions targeting anxiety regulation, fear of recurrence, and depressive symptoms. They also underline the necessity of intensifying interventions through including other components (e.g., emotion regulation, repetitive exposures to fear, treatment of intrusive thoughts, attention reorientation).
2. Objectives of the study
The primary aims of this study are to evaluate in a randomized controlled trial (RCT) the efficacy of an 8-session multi-component group intervention extended over 4 months in promoting emotion regulation (in an emotion regulation task and in everyday life) and patient emotional well-being compared with a waiting-list control group. The secondary aims are to evaluate patients' satisfaction with the program, hypnosis/relaxation practice in everyday life, mental adjustment, and changes in patients' level of attentional bias toward cancer threat and physical activity.
3. Participants
Patients who have been treated for a non-metastatic breast cancer will be approached at the end of active cancer treatment (i.e., surgery, chemotherapy, and radiotherapy) in order to be screened for emotion dysregulation. Patients experiencing moderate to high emotion dysregulation (one to four scores = or \> 4 on a 11-point Likert adapted Edmonton symptoms evaluation scale assessing anxiety, fear of recurrence, depression, and intrusive thoughts) will be offered the intervention.
4. Intervention
4.1. Theoretical framework
This is a multi-component group intervention integrating an emotion regulation and an exposure to fear component.
4.1.1. The emotion regulation component builds upon the Adaptive Coping with Emotions Model which was developed to provide a conceptualization of adaptive emotion regulation. It aims to help patients to better identify their physical, emotional and behavioral responses to their positive and negative emotions in order to be able to better regulate or acknowledge those emotions. This component integrates a self-regulation component. The self-regulation component relies on a phone app-based coaching intervention aiming at promoting changes in patients' ability to regulate their emotions in their everyday life. It aims at promoting patients' self-awareness of their internal states, orientating their attention consciously toward positive stimuli and at developing physical activity. Hypnosis is used as hetero-hypnosis in each session and aims at deepening the development of patients' emotion regulation skills. Recordings of the exercises done in session are transmitted to the patients in order to promote use of the technique at home. Helping patients develop autohypnosis skills is important as it may allow them to better regulate their emotions in everyday life.
4.1.2. The exposure to fear component aims at helping patients deal with their fear of death. Just as anxiety is a normal emotion, anxiety concerning death is also a normal experience. The modest level of death anxiety that most people experience in everyday life may increase dramatically when one experiences a period of health problems, illness, or death of someone close (Kastenbaum, 2000). This part of the intervention will be based on worry exposure. This part of the intervention targets cancer-related worry and is based on Borkovec's avoidance theory of worry (Borkovec et al., 1998). Worry is a predominantly cognitive-verbal activity that inhibits full emotional processing. As a result, disturbing emotional meanings of potentially dangerous and anxiously anticipated events cannot be fully tested or altered, making the repetitive processing of the feared stimuli probable (Foa \& Kozak, 1986). Given that cancer-recurrence related-worry is typically characterized by the focus on one hypothetical future event, it follows that exposure with imagined stimuli could be a crucial component of the treatment of fear of recurrence. The intervention will be based on two exercises. In the first, patients will be accompanied through a hypnosis based exposure to a major trigger of fear of recurrence that is the anticipation of the cancer check-up. This exercise is designed to help patients experience the emotions which may arise in this context while being guided through their resolution and regulation. The second exercise aims at helping them overcome their fear of recurrence through discussing their worst-case scenario in the group. The scenario are then discussed in order to highlight which part of them could be modified because it is unrealistic or because patients have more resources than they anticipate.
4.2. Study design and assessment schedule
This is a two-armed, randomized, waiting-list controlled trial. Patients who agree to participate will be randomly assigned to two groups: 1) the experimental group (EG) where six patients will receive one individual pre-group session and 8 sessions of group intervention combining cognitive-behavioral therapy and hypnosis; and 2) the waiting-list control group (CG) where six patients will receive the same intervention 4 months later. Patients will be assessed at three time points: 1) at baseline (T1), 2) 4 months later (T2), that means just after the intervention for the experimental group (EG) and just before the intervention for the control group (CG), and 3) 4 months later (T3), that means 4 months after the T2 for the experimental group and just after the intervention for the control group (CG).
4.2.1. Pre-assessment screening
Before inclusion in the study, during the last weeks of treatment (T0), approached patients will complete a socio-demographic questionnaire, a screening of life habits and difficulties questionnaire, an adapted Edmonton symptom evaluation scale (Chang, Hwang \& Feuerman, 2000) (assessing pain, fatigue, sleep disturbances, fatigue, difficulty concentrating, memory loss, feeling of malaise, hot flashes, depression, anxiety, fear of recurrence, and worry), the Hospital anxiety and depression scale (HADS) (Zigmond \& Snaith, 1983), and the Fear of Cancer Recurrence Inventory Severity sub-scale (Simard \& Savard, 2009). Patients will report medical information about their disease, previous and current treatment and prognosis. This screening allows checking for inclusion and exclusion criteria and comparing patients who accept and refuse the intervention.
4.2.2. Assessment procedure
Each assessment procedure (i.e., T1, T2, T3) includes three parts: an emotion regulation task, an ecological momentary assessment and an attentional bias task. Two months after T1 and T2, the experimental (EG) and control (CG) groups will be contacted once by phone to complete a phone-based questionnaire to assess their usual care use.
4.2.2.1. Emotion regulation task
This assessment procedure has been used in a previous project and provides a dynamic picture of patients' emotion regulation. Each assessment session will first involve completion of questionnaires and two emotion regulation exercises: (1) 4 min exposure to anxiety triggers through completion of the Mental Adjustment to Cancer Scale (Watson et al., 1988), followed by a 12-min self-relaxation exercise in which patients will be asked to relax by using their own strategies; and (2) 4 min exposure to anxiety triggers through completion of the Impact of Cancer Questionnaire (Zebrack et al., 2006), followed by a 12-min guided hypnosis exercise in which patients will be asked to listen to an audio recording of a hypnotic induction script. The subtasks will be separated by a period of questionnaires completion. Patients' emotion regulation will be measured physiologically (heart rate measurement) and psychologically (anxiety, sadness, fear of recurrence and energy state-levels).
4.2.2.2. Ecological momentary assessment (EMA)
Patients' emotion regulation in their everyday life will be assessed during 9 days through an ecological momentary assessment (EMA) procedure. Firstly, patients will be asked 5 times a day to select on a list of 20 emotions the 2 or 3 that they were experiencing during the minutes before they saw the notification. For each emotion experienced, they will have to report its intensity on a 10-point Likert scale ranging from 1 to 10. They will have to report to what extent they have felt able to control those emotions and have felt submerged by those emotions. They will report whether during those minutes they had been thinking about something other than what they were currently doing. They will have to answer with one of four options: no; yes, something pleasant; yes, something neutral; or yes, something unpleasant (Killingsworth \& Gilbert, 2010). Finally, they will be asked their level of fatigue and energy. Prompts will be sent randomly from 9 AM to 7,5 PM through the use of the software from http://www.lifedatacorp.com/. Secondly, each evening for 9 consecutive days, patients will have to indicate on the same list of 20 emotions (10 positive and 10 negative emotions), the extent to which they have felt each of the 20 emotions in the past 24 hours and their level of fatigue, from 0 (not at all) to 4 (extremely) (Fredrickson et al., 2003). In order to insure confidentiality, subjects will be provided with an iPod Touch. The two first days of data collection will be used as a training for participants and only their responses on the 7 following days will be taken into consideration. Thirdly, patients will be provided with an armband to continuously record during those 9 days, their heart rate levels, physical activity levels (pedometer and accelerometer) and sleep patterns (Garmin vívoactive HR).
4.2.2.3. Attentional bias task
Patients will complete an attentional bias computer task assessing attentional orientation toward emotional information. An adaptive function of biased attentional orientation toward negative information is to facilitate detection of danger in the environment and to help the organism respond effectively to threatening situations (Bar-Haim et al., 2007). When anxiety symptoms become excessive, biased attentional orientation toward negative information may have detrimental effects on patients' cognitive (e.g., intrusive thoughts, misinterpretation), behavioral (e.g., body screening, future planning difficulties), emotional (e.g., negative affects, panic attacks), and physiological status (e.g., physiological stress activation), and may play a prominent role in the etiology and maintenance of anxiety disorders (Bar-Haim et al., 2007). Computer tasks have been used to study the threat-related attentional bias in anxiety.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Breast Cancer
Emotional Disturbances
Emotional Dysfunction
Anxiety Depression
Fear of Cancer
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Emotion Regulation
Post-Treatment Breast Cancer Care
Cognitive-Behavioral Therapy
CBT
Hypnosis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
This is a two-armed, randomized, waiting-list controlled trial. Patients who agree to participate in the study will be randomly assigned to two groups: 1) the experimental group (EG) where six patients will receive one individual pre-group session and 8 sessions of group intervention combining cognitive-behavioral therapy and hypnosis; and 2) the waiting-list control group (CG) where six patients will receive the same intervention 4 months later. Patients will be assessed at three time points: 1) at baseline (T1), 2) 4 months later (T2), that means just after the intervention for the experimental group (EG) and just before the intervention for the control group (CG), and 3) 4 months later (T3), that means 4 months after the T2 for the experimental group and just after the intervention for the control group (CG).
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental Group
Patients include in the experimental group (EG) will receive one individual pre-group session and 8 sessions of group intervention combining cognitive-behavioral therapy and hypnosis after the first assessment (T1) (i.e., before the second assessment taking place 4 months later (T2)). They will resort to usual care only after the second assessment (T2) (i.e., before the third assessment taking place 4 months later (T3)).
Group Type
OTHER
Cognitive-Behavioral Group Therapy and Hypnosis
Intervention Type
BEHAVIORAL
The intervention consists in a pre-group interview and eight 2,5 h-session extended over 4 months. The intervention is based on cognitive-behavioral group therapy and hypnosis. To promote use of hypnosis at home, patients will receive audiorecordings of the hypnosis exercises. Starting immediately after the pre-group interview, the group will receive 3 app prompts a day promoting self-awareness and modulation of internal states, orientation of attention toward positive stimuli and inviting them to increase physical activity. Patients will be given a patient manual to promote an active approach to changes.
Waiting-List Control Group
Patients include in the waiting-list control group (CG) will resort to usual care only after the first assessment (T1) (i.e., before the second assessment taking place 4 months later (T2)). They will receive one individual pre-group session and 8 sessions of group intervention combining cognitive-behavioral therapy and hypnosis after the second assessment (T2) (i.e., before the third assessment taking place 4 months later (T3)).
Group Type
OTHER
Cognitive-Behavioral Group Therapy and Hypnosis
Intervention Type
BEHAVIORAL
The intervention consists in a pre-group interview and eight 2,5 h-session extended over 4 months. The intervention is based on cognitive-behavioral group therapy and hypnosis. To promote use of hypnosis at home, patients will receive audiorecordings of the hypnosis exercises. Starting immediately after the pre-group interview, the group will receive 3 app prompts a day promoting self-awareness and modulation of internal states, orientation of attention toward positive stimuli and inviting them to increase physical activity. Patients will be given a patient manual to promote an active approach to changes.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cognitive-Behavioral Group Therapy and Hypnosis
The intervention consists in a pre-group interview and eight 2,5 h-session extended over 4 months. The intervention is based on cognitive-behavioral group therapy and hypnosis. To promote use of hypnosis at home, patients will receive audiorecordings of the hypnosis exercises. Starting immediately after the pre-group interview, the group will receive 3 app prompts a day promoting self-awareness and modulation of internal states, orientation of attention toward positive stimuli and inviting them to increase physical activity. Patients will be given a patient manual to promote an active approach to changes.
Intervention Type
BEHAVIORAL
Cognitive-Behavioral Group Therapy and Hypnosis
The intervention consists in a pre-group interview and eight 2,5 h-session extended over 4 months. The intervention is based on cognitive-behavioral group therapy and hypnosis. To promote use of hypnosis at home, patients will receive audiorecordings of the hypnosis exercises. Starting immediately after the pre-group interview, the group will receive 3 app prompts a day promoting self-awareness and modulation of internal states, orientation of attention toward positive stimuli and inviting them to increase physical activity. Patients will be given a patient manual to promote an active approach to changes.
Intervention Type
BEHAVIORAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Experiencing moderate to high emotion dysregulation (one to four scores = or \> 4 on a 11-point Likert adapted Edmonton symptoms evaluation scale assessing anxiety, fear of recurrence, depression, and intrusive thoughts)
* Non-metastatic breast cancer
* Post chimiotherapy, radiotherapy, surgery treatment
* Age \> 18 years
* Completing a written informed consent
* Non-metastatic breast cancer
* Post chimiotherapy, radiotherapy, surgery treatment
* Age \> 18 years
* Completing a written informed consent
Exclusion Criteria
* Male
* Non-fluency in French
* Severe cognitive impairment
* Severe and/or acute psychiatric disorder.
* Non-fluency in French
* Severe cognitive impairment
* Severe and/or acute psychiatric disorder.
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jules Bordet Institute
OTHER
Sponsor Role
collaborator
Centre de Psycho-Oncologie (CPO)
OTHER
Sponsor Role
collaborator
Université Libre de Bruxelles
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Isabelle Merckaert
PhD, Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Darius Razavi, Prof
Role: PRINCIPAL_INVESTIGATOR
Université Libre de Bruxelles, Institut Jules Bordet
Isabelle Merckaert, Prof
Role: PRINCIPAL_INVESTIGATOR
Université Libre de Bruxelles, Institut Jules Bordet
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institut Jules Bordet
Brussels, , Belgium
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Belgium
References
Explore related publications, articles, or registry entries linked to this study.
Costanzo ES, Lutgendorf SK, Mattes ML, Trehan S, Robinson CB, Tewfik F, Roman SL. Adjusting to life after treatment: distress and quality of life following treatment for breast cancer. Br J Cancer. 2007 Dec 17;97(12):1625-31. doi: 10.1038/sj.bjc.6604091. Epub 2007 Nov 13.
Reference Type
BACKGROUND
Stanton AL, Ganz PA, Rowland JH, Meyerowitz BE, Krupnick JL, Sears SR. Promoting adjustment after treatment for cancer. Cancer. 2005 Dec 1;104(11 Suppl):2608-13. doi: 10.1002/cncr.21246.
Reference Type
BACKGROUND
Devine EC, Westlake SK. The effects of psychoeducational care provided to adults with cancer: meta-analysis of 116 studies. Oncol Nurs Forum. 1995 Oct;22(9):1369-81.
Reference Type
BACKGROUND
Stanton AL. Psychosocial concerns and interventions for cancer survivors. J Clin Oncol. 2006 Nov 10;24(32):5132-7. doi: 10.1200/JCO.2006.06.8775.
Reference Type
BACKGROUND
Jacobsen PB, Jim HS. Psychosocial interventions for anxiety and depression in adult cancer patients: achievements and challenges. CA Cancer J Clin. 2008 Jul-Aug;58(4):214-30. doi: 10.3322/CA.2008.0003. Epub 2008 Jun 16.
Reference Type
BACKGROUND
Duijts SF, Faber MM, Oldenburg HS, van Beurden M, Aaronson NK. Effectiveness of behavioral techniques and physical exercise on psychosocial functioning and health-related quality of life in breast cancer patients and survivors--a meta-analysis. Psychooncology. 2011 Feb;20(2):115-26. doi: 10.1002/pon.1728.
Reference Type
BACKGROUND
Sheard T, Maguire P. The effect of psychological interventions on anxiety and depression in cancer patients: results of two meta-analyses. Br J Cancer. 1999 Aug;80(11):1770-80. doi: 10.1038/sj.bjc.6690596.
Reference Type
BACKGROUND
Lang PJ, Davis M, Ohman A. Fear and anxiety: animal models and human cognitive psychophysiology. J Affect Disord. 2000 Dec;61(3):137-59. doi: 10.1016/s0165-0327(00)00343-8.
Reference Type
BACKGROUND
Stark DP, House A. Anxiety in cancer patients. Br J Cancer. 2000 Nov;83(10):1261-7. doi: 10.1054/bjoc.2000.1405.
Reference Type
BACKGROUND
Traeger L, Greer JA, Fernandez-Robles C, Temel JS, Pirl WF. Evidence-based treatment of anxiety in patients with cancer. J Clin Oncol. 2012 Apr 10;30(11):1197-205. doi: 10.1200/JCO.2011.39.5632. Epub 2012 Mar 12.
Reference Type
BACKGROUND
Bar-Haim Y, Lamy D, Pergamin L, Bakermans-Kranenburg MJ, van IJzendoorn MH. Threat-related attentional bias in anxious and nonanxious individuals: a meta-analytic study. Psychol Bull. 2007 Jan;133(1):1-24. doi: 10.1037/0033-2909.133.1.1.
Reference Type
BACKGROUND
Lebel S, Rosberger Z, Edgar L, Devins GM. Emotional distress impacts fear of the future among breast cancer survivors not the reverse. J Cancer Surviv. 2009 Jun;3(2):117-27. doi: 10.1007/s11764-009-0082-5. Epub 2009 Mar 26.
Reference Type
BACKGROUND
Llewellyn CD, Weinman J, McGurk M, Humphris G. Can we predict which head and neck cancer survivors develop fears of recurrence? J Psychosom Res. 2008 Dec;65(6):525-32. doi: 10.1016/j.jpsychores.2008.03.014. Epub 2008 Sep 24.
Reference Type
BACKGROUND
Baker F, Denniston M, Smith T, West MM. Adult cancer survivors: how are they faring? Cancer. 2005 Dec 1;104(11 Suppl):2565-76. doi: 10.1002/cncr.21488.
Reference Type
BACKGROUND
Armes J, Crowe M, Colbourne L, Morgan H, Murrells T, Oakley C, Palmer N, Ream E, Young A, Richardson A. Patients' supportive care needs beyond the end of cancer treatment: a prospective, longitudinal survey. J Clin Oncol. 2009 Dec 20;27(36):6172-9. doi: 10.1200/JCO.2009.22.5151. Epub 2009 Nov 2.
Reference Type
BACKGROUND
Harrison SE, Watson EK, Ward AM, Khan NF, Turner D, Adams E, Forman D, Roche MF, Rose PW. Primary health and supportive care needs of long-term cancer survivors: a questionnaire survey. J Clin Oncol. 2011 May 20;29(15):2091-8. doi: 10.1200/JCO.2010.32.5167. Epub 2011 Apr 25.
Reference Type
BACKGROUND
Sanson-Fisher R, Girgis A, Boyes A, Bonevski B, Burton L, Cook P. The unmet supportive care needs of patients with cancer. Supportive Care Review Group. Cancer. 2000 Jan 1;88(1):226-37. doi: 10.1002/(sici)1097-0142(20000101)88:13.3.co;2-g.
Reference Type
BACKGROUND
Hopwood P, Sumo G, Mills J, Haviland J, Bliss JM; START Trials Management Group. The course of anxiety and depression over 5 years of follow-up and risk factors in women with early breast cancer: results from the UK Standardisation of Radiotherapy Trials (START). Breast. 2010 Apr;19(2):84-91. doi: 10.1016/j.breast.2009.11.007. Epub 2009 Dec 29.
Reference Type
BACKGROUND
Lebel S, Rosberger Z, Edgar L, Devins GM. Comparison of four common stressors across the breast cancer trajectory. J Psychosom Res. 2007 Sep;63(3):225-32. doi: 10.1016/j.jpsychores.2007.02.002. Epub 2007 Aug 2.
Reference Type
BACKGROUND
Visser MR, Smets EM. Fatigue, depression and quality of life in cancer patients: how are they related? Support Care Cancer. 1998 Mar;6(2):101-8. doi: 10.1007/s005200050142.
Reference Type
BACKGROUND
DiMatteo MR, Lepper HS, Croghan TW. Depression is a risk factor for noncompliance with medical treatment: meta-analysis of the effects of anxiety and depression on patient adherence. Arch Intern Med. 2000 Jul 24;160(14):2101-7. doi: 10.1001/archinte.160.14.2101.
Reference Type
BACKGROUND
Falagas ME, Zarkadoulia EA, Ioannidou EN, Peppas G, Christodoulou C, Rafailidis PI. The effect of psychosocial factors on breast cancer outcome: a systematic review. Breast Cancer Res. 2007;9(4):R44. doi: 10.1186/bcr1744.
Reference Type
BACKGROUND
Bjorneklett HG, Lindemalm C, Rosenblad A, Ojutkangas ML, Letocha H, Strang P, Bergkvist L. A randomised controlled trial of support group intervention after breast cancer treatment: results on anxiety and depression. Acta Oncol. 2012 Feb;51(2):198-207. doi: 10.3109/0284186X.2011.610352. Epub 2011 Sep 19.
Reference Type
BACKGROUND
Naaman SC, Radwan K, Fergusson D, Johnson S. Status of psychological trials in breast cancer patients: a report of three meta-analyses. Psychiatry. 2009 Spring;72(1):50-69. doi: 10.1521/psyc.2009.72.1.50.
Reference Type
BACKGROUND
Osborn RL, Demoncada AC, Feuerstein M. Psychosocial interventions for depression, anxiety, and quality of life in cancer survivors: meta-analyses. Int J Psychiatry Med. 2006;36(1):13-34. doi: 10.2190/EUFN-RV1K-Y3TR-FK0L.
Reference Type
BACKGROUND
Lengacher CA, Johnson-Mallard V, Post-White J, Moscoso MS, Jacobsen PB, Klein TW, Widen RH, Fitzgerald SG, Shelton MM, Barta M, Goodman M, Cox CE, Kip KE. Randomized controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer. Psychooncology. 2009 Dec;18(12):1261-72. doi: 10.1002/pon.1529.
Reference Type
BACKGROUND
Wurtzen H, Dalton SO, Elsass P, Sumbundu AD, Steding-Jensen M, Karlsen RV, Andersen KK, Flyger HL, Pedersen AE, Johansen C. Mindfulness significantly reduces self-reported levels of anxiety and depression: results of a randomised controlled trial among 336 Danish women treated for stage I-III breast cancer. Eur J Cancer. 2013 Apr;49(6):1365-73. doi: 10.1016/j.ejca.2012.10.030. Epub 2012 Dec 19.
Reference Type
BACKGROUND
Dolbeault S, Cayrou S, Bredart A, Viala AL, Desclaux B, Saltel P, Gauvain-Piquard A, Hardy P, Dickes P. The effectiveness of a psycho-educational group after early-stage breast cancer treatment: results of a randomized French study. Psychooncology. 2009 Jun;18(6):647-56. doi: 10.1002/pon.1440.
Reference Type
BACKGROUND
Scheier MF, Helgeson VS, Schulz R, Colvin S, Berga S, Bridges MW, Knapp J, Gerszten K, Pappert WS. Interventions to enhance physical and psychological functioning among younger women who are ending nonhormonal adjuvant treatment for early-stage breast cancer. J Clin Oncol. 2005 Jul 1;23(19):4298-311. doi: 10.1200/JCO.2005.05.362.
Reference Type
BACKGROUND
Fors EA, Bertheussen GF, Thune I, Juvet LK, Elvsaas IK, Oldervoll L, Anker G, Falkmer U, Lundgren S, Leivseth G. Psychosocial interventions as part of breast cancer rehabilitation programs? Results from a systematic review. Psychooncology. 2011 Sep;20(9):909-18. doi: 10.1002/pon.1844. Epub 2010 Sep 6.
Reference Type
BACKGROUND
Duijts SF, van Beurden M, Oldenburg HS, Hunter MS, Kieffer JM, Stuiver MM, Gerritsma MA, Menke-Pluymers MB, Plaisier PW, Rijna H, Lopes Cardozo AM, Timmers G, van der Meij S, van der Veen H, Bijker N, de Widt-Levert LM, Geenen MM, Heuff G, van Dulken EJ, Boven E, Aaronson NK. Efficacy of cognitive behavioral therapy and physical exercise in alleviating treatment-induced menopausal symptoms in patients with breast cancer: results of a randomized, controlled, multicenter trial. J Clin Oncol. 2012 Nov 20;30(33):4124-33. doi: 10.1200/JCO.2012.41.8525. Epub 2012 Oct 8.
Reference Type
BACKGROUND
Savard J, Simard S, Ivers H, Morin CM. Randomized study on the efficacy of cognitive-behavioral therapy for insomnia secondary to breast cancer, part I: Sleep and psychological effects. J Clin Oncol. 2005 Sep 1;23(25):6083-96. doi: 10.1200/JCO.2005.09.548.
Reference Type
BACKGROUND
Savard J, Simard S, Ivers H, Morin CM. Randomized study on the efficacy of cognitive-behavioral therapy for insomnia secondary to breast cancer, part II: Immunologic effects. J Clin Oncol. 2005 Sep 1;23(25):6097-106. doi: 10.1200/JCO.2005.12.513.
Reference Type
BACKGROUND
Montazeri A, Jarvandi S, Haghighat S, Vahdani M, Sajadian A, Ebrahimi M, Haji-Mahmoodi M. Anxiety and depression in breast cancer patients before and after participation in a cancer support group. Patient Educ Couns. 2001 Dec 1;45(3):195-8. doi: 10.1016/s0738-3991(01)00121-5.
Reference Type
BACKGROUND
Elsesser, K., Van Berkel, M., & Sartory, G. (1994). The effects of anxiety management training on psychological variables and immune parameters in cancer patients. Behavioural and Cognitive Psychotherapy, 22, 13-23.
Reference Type
BACKGROUND
Hidderley M, Holt M. A pilot randomized trial assessing the effects of autogenic training in early stage cancer patients in relation to psychological status and immune system responses. Eur J Oncol Nurs. 2004 Mar;8(1):61-5. doi: 10.1016/j.ejon.2003.09.003.
Reference Type
BACKGROUND
Humphris G, Ozakinci G. The AFTER intervention: a structured psychological approach to reduce fears of recurrence in patients with head and neck cancer. Br J Health Psychol. 2008 May;13(Pt 2):223-30. doi: 10.1348/135910708X283751.
Reference Type
BACKGROUND
Lebel S, Maheu C, Lefebvre M, Secord S, Courbasson C, Singh M, Jolicoeur L, Benea A, Harris C, Fung MF, Rosberger Z, Catton P. Addressing fear of cancer recurrence among women with cancer: a feasibility and preliminary outcome study. J Cancer Surviv. 2014 Sep;8(3):485-96. doi: 10.1007/s11764-014-0357-3. Epub 2014 Apr 23.
Reference Type
BACKGROUND
Mishel MH, Germino BB, Gil KM, Belyea M, Laney IC, Stewart J, Porter L, Clayton M. Benefits from an uncertainty management intervention for African-American and Caucasian older long-term breast cancer survivors. Psychooncology. 2005 Nov;14(11):962-78. doi: 10.1002/pon.909.
Reference Type
BACKGROUND
Simard S, Thewes B, Humphris G, Dixon M, Hayden C, Mireskandari S, Ozakinci G. Fear of cancer recurrence in adult cancer survivors: a systematic review of quantitative studies. J Cancer Surviv. 2013 Sep;7(3):300-22. doi: 10.1007/s11764-013-0272-z. Epub 2013 Mar 10.
Reference Type
BACKGROUND
Herschbach P, Book K, Dinkel A, Berg P, Waadt S, Duran G, Engst-Hastreiter U, Henrich G. Evaluation of two group therapies to reduce fear of progression in cancer patients. Support Care Cancer. 2010 Apr;18(4):471-9. doi: 10.1007/s00520-009-0696-1. Epub 2009 Oct 29.
Reference Type
BACKGROUND
Chambless DL, Ollendick TH. Empirically supported psychological interventions: controversies and evidence. Annu Rev Psychol. 2001;52:685-716. doi: 10.1146/annurev.psych.52.1.685.
Reference Type
BACKGROUND
Deacon BJ, Abramowitz JS. Cognitive and behavioral treatments for anxiety disorders: a review of meta-analytic findings. J Clin Psychol. 2004 Apr;60(4):429-41. doi: 10.1002/jclp.10255.
Reference Type
BACKGROUND
Norton PJ, Price EC. A meta-analytic review of adult cognitive-behavioral treatment outcome across the anxiety disorders. J Nerv Ment Dis. 2007 Jun;195(6):521-31. doi: 10.1097/01.nmd.0000253843.70149.9a.
Reference Type
BACKGROUND
Stewart RE, Chambless DL. Cognitive-behavioral therapy for adult anxiety disorders in clinical practice: a meta-analysis of effectiveness studies. J Consult Clin Psychol. 2009 Aug;77(4):595-606. doi: 10.1037/a0016032.
Reference Type
BACKGROUND
Hammond DC. Hypnosis in the treatment of anxiety- and stress-related disorders. Expert Rev Neurother. 2010 Feb;10(2):263-73. doi: 10.1586/ern.09.140.
Reference Type
BACKGROUND
Kirsch I, Montgomery G, Sapirstein G. Hypnosis as an adjunct to cognitive-behavioral psychotherapy: a meta-analysis. J Consult Clin Psychol. 1995 Apr;63(2):214-20. doi: 10.1037//0022-006x.63.2.214.
Reference Type
BACKGROUND
Merckaert I, Lewis F, Delevallez F, Herman S, Caillier M, Delvaux N, Libert Y, Lienard A, Nogaret JM, Ogez D, Scalliet P, Slachmuylder JL, Van Houtte P, Razavi D. Improving anxiety regulation in patients with breast cancer at the beginning of the survivorship period: a randomized clinical trial comparing the benefits of single-component and multiple-component group interventions. Psychooncology. 2017 Aug;26(8):1147-1154. doi: 10.1002/pon.4294. Epub 2016 Nov 7.
Reference Type
BACKGROUND
Berking, M., & Schwarz, J. (2013). Affect regulation training. Handbook of Emotion Regulation. New York: Guilford.
Reference Type
BACKGROUND
Kastenbaum, R. (2000). The psychology of death (3rd ed.). New York: Springer.
Reference Type
BACKGROUND
Borkovec, T.D., et al. (1998). Worry: a cognitive phenomenon intimately linked to affective, physiological, and interpersonal behavioral processes. Cognitive Therapy and Research, 22(6), 561-576.
Reference Type
BACKGROUND
Foa EB, Kozak MJ. Emotional processing of fear: exposure to corrective information. Psychol Bull. 1986 Jan;99(1):20-35. No abstract available.
Reference Type
BACKGROUND
Merckaert, I., et al. (2016). Emotion regulation at the beginning of the survivorship period for breast cancer: Comparing the impact of an 8-session to a 15-session multicomponent group intervention, submitted abstract. Psychooncology.
Reference Type
BACKGROUND
Chang VT, Hwang SS, Feuerman M. Validation of the Edmonton Symptom Assessment Scale. Cancer. 2000 May 1;88(9):2164-71. doi: 10.1002/(sici)1097-0142(20000501)88:93.0.co;2-5.
Reference Type
BACKGROUND
Simard S, Savard J. Fear of Cancer Recurrence Inventory: development and initial validation of a multidimensional measure of fear of cancer recurrence. Support Care Cancer. 2009 Mar;17(3):241-51. doi: 10.1007/s00520-008-0444-y. Epub 2008 Apr 15.
Reference Type
BACKGROUND
Watson M, Greer S, Young J, Inayat Q, Burgess C, Robertson B. Development of a questionnaire measure of adjustment to cancer: the MAC scale. Psychol Med. 1988 Feb;18(1):203-9. doi: 10.1017/s0033291700002026.
Reference Type
BACKGROUND
Zebrack BJ, Ganz PA, Bernaards CA, Petersen L, Abraham L. Assessing the impact of cancer: development of a new instrument for long-term survivors. Psychooncology. 2006 May;15(5):407-21. doi: 10.1002/pon.963.
Reference Type
BACKGROUND
Killingsworth MA, Gilbert DT. A wandering mind is an unhappy mind. Science. 2010 Nov 12;330(6006):932. doi: 10.1126/science.1192439.
Reference Type
BACKGROUND
Fredrickson BL, Losada MF. Positive affect and the complex dynamics of human flourishing. Am Psychol. 2005 Oct;60(7):678-86. doi: 10.1037/0003-066X.60.7.678.
Reference Type
BACKGROUND
Zelenski, J. M., & Larsen, R. J. (2000). The Distribution of Basic Emotions in Everyday Life: A State and Trait Perspective from Experience Sampling Data. Journal of Research in Personality, 34(2), 178-197.
Reference Type
BACKGROUND
Fredrickson BL. The role of positive emotions in positive psychology. The broaden-and-build theory of positive emotions. Am Psychol. 2001 Mar;56(3):218-26. doi: 10.1037//0003-066x.56.3.218.
Reference Type
BACKGROUND
Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.
Reference Type
BACKGROUND
Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
Reference Type
BACKGROUND
Davey HM, Barratt AL, Butow PN, Deeks JJ. A one-item question with a Likert or Visual Analog Scale adequately measured current anxiety. J Clin Epidemiol. 2007 Apr;60(4):356-60. doi: 10.1016/j.jclinepi.2006.07.015. Epub 2006 Dec 27.
Reference Type
BACKGROUND
Miller MD, Ferris DG. Measurement of subjective phenomena in primary care research: the Visual Analogue Scale. Fam Pract Res J. 1993 Mar;13(1):15-24.
Reference Type
BACKGROUND
Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.
Reference Type
BACKGROUND
Friedman BH. An autonomic flexibility-neurovisceral integration model of anxiety and cardiac vagal tone. Biol Psychol. 2007 Feb;74(2):185-99. doi: 10.1016/j.biopsycho.2005.08.009. Epub 2006 Oct 27.
Reference Type
BACKGROUND
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
Reference Type
BACKGROUND
Schmidt RE, Gay P, Courvoisier D, Jermann F, Ceschi G, David M, Brinkmann K, Van der Linden M. Anatomy of the White Bear Suppression Inventory (WBSI): a review of previous findings and a new approach. J Pers Assess. 2009 Jul;91(4):323-30. doi: 10.1080/00223890902935738.
Reference Type
BACKGROUND
Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29.
Reference Type
BACKGROUND
Wells A, Cartwright-Hatton S. A short form of the metacognitions questionnaire: properties of the MCQ-30. Behav Res Ther. 2004 Apr;42(4):385-96. doi: 10.1016/S0005-7967(03)00147-5.
Reference Type
BACKGROUND
Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
Reference Type
BACKGROUND
Jermann, F., et al. (2006). Cognitive Emotion Regulation Questionnaire (CERQ): Confirmatory Factor Analysis and Psychometric Properties of the French Translation. European Journal of Psychological Assessment, 22, 126-131.
Reference Type
BACKGROUND
Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o.
Reference Type
BACKGROUND
Killip S, Mahfoud Z, Pearce K. What is an intracluster correlation coefficient? Crucial concepts for primary care researchers. Ann Fam Med. 2004 May-Jun;2(3):204-8. doi: 10.1370/afm.141.
Reference Type
BACKGROUND
Merckaert I, Waroquier P, Caillier M, Verkaeren O, Righes S, Lienard A, Libert Y, Kristanto P, Razavi D. Improving emotion regulation in breast cancer patients in the early survivorship period: Efficacy of a brief ecologically boosted group intervention. Psychooncology. 2023 Apr;32(4):597-609. doi: 10.1002/pon.6105. Epub 2023 Mar 8.
Reference Type
DERIVED
Study Documents
Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.
Document Type: Study design
View DocumentDocument Type: List of questionnaires
View DocumentDocument Type: Informed Consent Form
View DocumentDocument Type: Informed Consent Form
View DocumentOther Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Emotion Regulation
Identifier Type: -
Identifier Source: org_study_id