Enhancing Social Interaction in Depression (SIDE study): protocol of a randomised controlled trial on the effects of a Cognitively Based Compassion Training (CBCT) for couples

Corina Aguilar-Raab, Marc N. Jarczok, Marco Warth, Martin Stoffel, Friederike Winter, Maria Tieck, Judith Berg, Lobsang Tenzin Negi, Tim Harrison, Thaddeus Wesley Warren Pace, Beate Ditzen

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

INTRODUCTION: Positive social interactions (PSIs) and stable relationships can exert substantial benefits on health. However, patients suffering from depression benefit less from these health-promoting effects. Moreover, relationship quality and even partners' health has been found to be negatively affected by depressive symptomatology, which may result in overall impairments in social functioning of a romantic couple. Psychobiological research indicates that these impairments may be accompanied by a maladaptive regulation of the patient's neuroendocrine response to external stressors. Concerning the improvement of social functioning, first studies showed promising results of "Cognitively Based Compassion Training (CBCT®)". However, randomised trials are still scarce. Previous programmes did not involve participation of the patient's romantic partner. Therefore, the present study aims to investigate whether a CBCT® programme adapted for couples (CBCT®-fC) can improve depressive symptoms, distress, social interaction skills and the neurobiological regulation of stress.

METHODS AND ANALYSIS: Couples with the female partner suffering from depression will be invited to participate in a pre-to-post intervention assessment on two consecutive days, respectively, involving a standardised PSI task, eye-tracking, ECG recordings, saliva-sampling, blood-sampling and questionnaire data. After baseline assessment, participating couples will be randomised to either a 10 week CBCT®-fC or to a treatment as usual control condition. The primary endpoint is the reduction of depressive symptoms measured by the Hamilton Depression Rating Scale. Secondary outcomes encompass self-rated depression (Beck Depression Inventory), attention towards the partners face during PSI (eye tracking), stress-related biomarkers (cortisol, α-amylase, interleukin (IL)-1ß/IL-6, heart rate variability), methylation of oxytocin-receptor-genes and serotonin-transporter-genes and self-ratings of psychological constructs such as relationship quality and empathy.

ETHICS AND DISSEMINATION: Ethical approval has been obtained by the Ethics Committee of the Medical Faculty Heidelberg. Results will be presented in international, peer-reviewed journals and on conferences in the field of clinical psychology and psychiatry.

TRIAL REGISTRATION NUMBER: NCT03080025.

Original languageEnglish (US)
Pages (from-to)e020448
JournalBMJ Open
Volume8
Issue number9
DOIs
StatePublished - Oct 4 2018

Fingerprint

Interpersonal Relations
Randomized Controlled Trials
Depression
Insurance Benefits
Oxytocin Receptors
Patient Participation
Clinical Psychology
Medical Faculties
Ethics Committees
Serotonin Plasma Membrane Transport Proteins
Amylases
Interleukin-1
Saliva
Methylation
Genes
Psychiatry
Hydrocortisone
Interleukin-6
Electrocardiography
Biomarkers

Keywords

  • mindfulness- and compassion based intervention
  • psychobiological indicators of health
  • study protocol

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Enhancing Social Interaction in Depression (SIDE study) : protocol of a randomised controlled trial on the effects of a Cognitively Based Compassion Training (CBCT) for couples. / Aguilar-Raab, Corina; Jarczok, Marc N.; Warth, Marco; Stoffel, Martin; Winter, Friederike; Tieck, Maria; Berg, Judith; Negi, Lobsang Tenzin; Harrison, Tim; Pace, Thaddeus Wesley Warren; Ditzen, Beate.

In: BMJ Open, Vol. 8, No. 9, 04.10.2018, p. e020448.

Research output: Contribution to journalArticle

Aguilar-Raab, Corina ; Jarczok, Marc N. ; Warth, Marco ; Stoffel, Martin ; Winter, Friederike ; Tieck, Maria ; Berg, Judith ; Negi, Lobsang Tenzin ; Harrison, Tim ; Pace, Thaddeus Wesley Warren ; Ditzen, Beate. / Enhancing Social Interaction in Depression (SIDE study) : protocol of a randomised controlled trial on the effects of a Cognitively Based Compassion Training (CBCT) for couples. In: BMJ Open. 2018 ; Vol. 8, No. 9. pp. e020448.
@article{82b7ba0fb4bd46feace1059b0557ee30,
title = "Enhancing Social Interaction in Depression (SIDE study): protocol of a randomised controlled trial on the effects of a Cognitively Based Compassion Training (CBCT) for couples",
abstract = "INTRODUCTION: Positive social interactions (PSIs) and stable relationships can exert substantial benefits on health. However, patients suffering from depression benefit less from these health-promoting effects. Moreover, relationship quality and even partners' health has been found to be negatively affected by depressive symptomatology, which may result in overall impairments in social functioning of a romantic couple. Psychobiological research indicates that these impairments may be accompanied by a maladaptive regulation of the patient's neuroendocrine response to external stressors. Concerning the improvement of social functioning, first studies showed promising results of {"}Cognitively Based Compassion Training (CBCT{\circledR}){"}. However, randomised trials are still scarce. Previous programmes did not involve participation of the patient's romantic partner. Therefore, the present study aims to investigate whether a CBCT{\circledR} programme adapted for couples (CBCT{\circledR}-fC) can improve depressive symptoms, distress, social interaction skills and the neurobiological regulation of stress.METHODS AND ANALYSIS: Couples with the female partner suffering from depression will be invited to participate in a pre-to-post intervention assessment on two consecutive days, respectively, involving a standardised PSI task, eye-tracking, ECG recordings, saliva-sampling, blood-sampling and questionnaire data. After baseline assessment, participating couples will be randomised to either a 10 week CBCT{\circledR}-fC or to a treatment as usual control condition. The primary endpoint is the reduction of depressive symptoms measured by the Hamilton Depression Rating Scale. Secondary outcomes encompass self-rated depression (Beck Depression Inventory), attention towards the partners face during PSI (eye tracking), stress-related biomarkers (cortisol, α-amylase, interleukin (IL)-1{\ss}/IL-6, heart rate variability), methylation of oxytocin-receptor-genes and serotonin-transporter-genes and self-ratings of psychological constructs such as relationship quality and empathy.ETHICS AND DISSEMINATION: Ethical approval has been obtained by the Ethics Committee of the Medical Faculty Heidelberg. Results will be presented in international, peer-reviewed journals and on conferences in the field of clinical psychology and psychiatry.TRIAL REGISTRATION NUMBER: NCT03080025.",
keywords = "mindfulness- and compassion based intervention, psychobiological indicators of health, study protocol",
author = "Corina Aguilar-Raab and Jarczok, {Marc N.} and Marco Warth and Martin Stoffel and Friederike Winter and Maria Tieck and Judith Berg and Negi, {Lobsang Tenzin} and Tim Harrison and Pace, {Thaddeus Wesley Warren} and Beate Ditzen",
year = "2018",
month = "10",
day = "4",
doi = "10.1136/bmjopen-2017-020448",
language = "English (US)",
volume = "8",
pages = "e020448",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "9",

}

TY - JOUR

T1 - Enhancing Social Interaction in Depression (SIDE study)

T2 - protocol of a randomised controlled trial on the effects of a Cognitively Based Compassion Training (CBCT) for couples

AU - Aguilar-Raab, Corina

AU - Jarczok, Marc N.

AU - Warth, Marco

AU - Stoffel, Martin

AU - Winter, Friederike

AU - Tieck, Maria

AU - Berg, Judith

AU - Negi, Lobsang Tenzin

AU - Harrison, Tim

AU - Pace, Thaddeus Wesley Warren

AU - Ditzen, Beate

PY - 2018/10/4

Y1 - 2018/10/4

N2 - INTRODUCTION: Positive social interactions (PSIs) and stable relationships can exert substantial benefits on health. However, patients suffering from depression benefit less from these health-promoting effects. Moreover, relationship quality and even partners' health has been found to be negatively affected by depressive symptomatology, which may result in overall impairments in social functioning of a romantic couple. Psychobiological research indicates that these impairments may be accompanied by a maladaptive regulation of the patient's neuroendocrine response to external stressors. Concerning the improvement of social functioning, first studies showed promising results of "Cognitively Based Compassion Training (CBCT®)". However, randomised trials are still scarce. Previous programmes did not involve participation of the patient's romantic partner. Therefore, the present study aims to investigate whether a CBCT® programme adapted for couples (CBCT®-fC) can improve depressive symptoms, distress, social interaction skills and the neurobiological regulation of stress.METHODS AND ANALYSIS: Couples with the female partner suffering from depression will be invited to participate in a pre-to-post intervention assessment on two consecutive days, respectively, involving a standardised PSI task, eye-tracking, ECG recordings, saliva-sampling, blood-sampling and questionnaire data. After baseline assessment, participating couples will be randomised to either a 10 week CBCT®-fC or to a treatment as usual control condition. The primary endpoint is the reduction of depressive symptoms measured by the Hamilton Depression Rating Scale. Secondary outcomes encompass self-rated depression (Beck Depression Inventory), attention towards the partners face during PSI (eye tracking), stress-related biomarkers (cortisol, α-amylase, interleukin (IL)-1ß/IL-6, heart rate variability), methylation of oxytocin-receptor-genes and serotonin-transporter-genes and self-ratings of psychological constructs such as relationship quality and empathy.ETHICS AND DISSEMINATION: Ethical approval has been obtained by the Ethics Committee of the Medical Faculty Heidelberg. Results will be presented in international, peer-reviewed journals and on conferences in the field of clinical psychology and psychiatry.TRIAL REGISTRATION NUMBER: NCT03080025.

AB - INTRODUCTION: Positive social interactions (PSIs) and stable relationships can exert substantial benefits on health. However, patients suffering from depression benefit less from these health-promoting effects. Moreover, relationship quality and even partners' health has been found to be negatively affected by depressive symptomatology, which may result in overall impairments in social functioning of a romantic couple. Psychobiological research indicates that these impairments may be accompanied by a maladaptive regulation of the patient's neuroendocrine response to external stressors. Concerning the improvement of social functioning, first studies showed promising results of "Cognitively Based Compassion Training (CBCT®)". However, randomised trials are still scarce. Previous programmes did not involve participation of the patient's romantic partner. Therefore, the present study aims to investigate whether a CBCT® programme adapted for couples (CBCT®-fC) can improve depressive symptoms, distress, social interaction skills and the neurobiological regulation of stress.METHODS AND ANALYSIS: Couples with the female partner suffering from depression will be invited to participate in a pre-to-post intervention assessment on two consecutive days, respectively, involving a standardised PSI task, eye-tracking, ECG recordings, saliva-sampling, blood-sampling and questionnaire data. After baseline assessment, participating couples will be randomised to either a 10 week CBCT®-fC or to a treatment as usual control condition. The primary endpoint is the reduction of depressive symptoms measured by the Hamilton Depression Rating Scale. Secondary outcomes encompass self-rated depression (Beck Depression Inventory), attention towards the partners face during PSI (eye tracking), stress-related biomarkers (cortisol, α-amylase, interleukin (IL)-1ß/IL-6, heart rate variability), methylation of oxytocin-receptor-genes and serotonin-transporter-genes and self-ratings of psychological constructs such as relationship quality and empathy.ETHICS AND DISSEMINATION: Ethical approval has been obtained by the Ethics Committee of the Medical Faculty Heidelberg. Results will be presented in international, peer-reviewed journals and on conferences in the field of clinical psychology and psychiatry.TRIAL REGISTRATION NUMBER: NCT03080025.

KW - mindfulness- and compassion based intervention

KW - psychobiological indicators of health

KW - study protocol

UR - http://www.scopus.com/inward/record.url?scp=85054445777&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85054445777&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2017-020448

DO - 10.1136/bmjopen-2017-020448

M3 - Article

C2 - 30287601

AN - SCOPUS:85054445777

VL - 8

SP - e020448

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 9

ER -