Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633263
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Combined Effect of TCC-I and BATD on Depressive Symptoms and Insomnia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Combined Effect of Cognitive Behavioral Therapy for Insomnia and a Behavioral Activation Program for Depression on Depressive Symptoms and Insomnia a Multiple Case Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goals of this interventional study is to study if the combine effects of Behavioral Activation Treatment for Depression BATD and Cognitive Behavioral Therapy for Insomnia CBT-I is effective on primary outcomes depression insomnia well-being and anxiety and secondary outcomes worry rumination behavioral inertia experiential avoidance anticipatory pleasure deficits cognitive resource deficits emotional reactivity quality of sleep and sleep beliefs for participants suffering from depression and insomnia disorders
Detailed Description:
Depression is a widespread mental disorder characterized by affective cognitive and physiological disturbances that impact individuals daily functioning Sleep difficulties are an essential component of the clinical picture of depression Several interventional studies have demonstrated the value of specific insomnia treatment in the management of depression Indeed the absence of targeted treatment for insomnia increases the risk of depressive relapse In this context the importance of specific treatment of insomnia in cases of comorbidity with depression and the need to integrate this approach into clinical practice have recently been highlighted However very few studies have explored the efficacy of combined treatment of insomnia with Cognitive Behavioural Therapy for Insomnia - CBT-I and depression with Behavioural Activation Treatment for Depression - BATD However one study has shown that BATD can have beneficial effects on sleep quality in caregivers of people with Alzheimers disease The combined treatment of CBT-I and BATD as well as the importance of the order of administration of these interventions in cases of insomnia-depression comorbidity however remain unexplored
The aim of this study is to evaluate the overall effect of the combination of CBT-I and a BATD on depressive symptoms and insomnia in the short medium and long term It also seeks to examine the specific effects of each intervention In addition the study assesses efficacy and adherence under two different orders of treatment combination while exploring the psychological mechanisms likely to promote positive symptoms change Finally it looks at inter-individual differences in responses to interventions Our study will help provide empirical evidence on the efficacy of combined treatment for people suffering from insomnia and depression By identifying the psychological mechanisms that may promote improvement in these comorbid disorders it could also help refine and improve current treatments
Participants will be recruited through a number of sources including the CPLU Clinique Psychologique et Logopédique de l Université de Liège word of mouth announcements within the University eg via the student and staff quality of life service social networks and various CHU departments A flyer will be distributed by clinicians and on social networks including Facebook Participants will also be identified through CHU psychologists doctors and psychiatrists who have potential access to the target population people suffering from sleep disorders and depression
An initial telephone interview will take place to check the inclusion and exclusion criteria explain how the study works and the various appointment dates
Participants wishing to take part in the study but presenting exclusion criteria will be redirected to appropriate care services according to their difficulties This may include services specializing in sleep disorders services dedicated to the management of psychological disorders psychiatric emergencies in the event of significant suicidal ideation or individual psychological follow-up by a specialized therapist such as primary care psychologists or CBT psychotherapists
If the person meets the criteria an initial interview will be arranged During this first clinical interview the protocol will be presented in greater detail Participants expectations and motivations will be investigated to ensure that the proposed intervention can meet them The information letter and informed consents will be offered to the participant A socio-demographic questionnaire will be proposed The content of the assessments to be completed daily will be presented to the participants At the end of this interview they will also be invited to complete the standardized pre-intervention questionnaires
Participants will then begin self-observation for two weeks before starting the first intervention CBT-I in condition 1 and BATD in condition 2 This will be followed by a further two-week period of observation without intervention prior to the second intervention BATD in condition 1 and CBT-I in condition 2 A final two-week self-observation phase follows the second intervention
The aim of this study is to evaluate the overall effect of the combination of CBT-I and a BATD on depressive symptoms and insomnia in the short medium and long term It also seeks to examine the specific effects of each intervention In addition the study assesses efficacy and adherence under two different orders of treatment combination while exploring the psychological mechanisms likely to promote positive symptoms change Finally it looks at inter-individual differences in responses to interventions Our study will help provide empirical evidence on the efficacy of combined treatment for people suffering from insomnia and depression By identifying the psychological mechanisms that may promote improvement in these comorbid disorders it could also help refine and improve current treatments
Participants will be recruited through a number of sources including the CPLU Clinique Psychologique et Logopédique de l Université de Liège word of mouth announcements within the University eg via the student and staff quality of life service social networks and various CHU departments A flyer will be distributed by clinicians and on social networks including Facebook Participants will also be identified through CHU psychologists doctors and psychiatrists who have potential access to the target population people suffering from sleep disorders and depression
An initial telephone interview will take place to check the inclusion and exclusion criteria explain how the study works and the various appointment dates
Participants wishing to take part in the study but presenting exclusion criteria will be redirected to appropriate care services according to their difficulties This may include services specializing in sleep disorders services dedicated to the management of psychological disorders psychiatric emergencies in the event of significant suicidal ideation or individual psychological follow-up by a specialized therapist such as primary care psychologists or CBT psychotherapists
If the person meets the criteria an initial interview will be arranged During this first clinical interview the protocol will be presented in greater detail Participants expectations and motivations will be investigated to ensure that the proposed intervention can meet them The information letter and informed consents will be offered to the participant A socio-demographic questionnaire will be proposed The content of the assessments to be completed daily will be presented to the participants At the end of this interview they will also be invited to complete the standardized pre-intervention questionnaires
Participants will then begin self-observation for two weeks before starting the first intervention CBT-I in condition 1 and BATD in condition 2 This will be followed by a further two-week period of observation without intervention prior to the second intervention BATD in condition 1 and CBT-I in condition 2 A final two-week self-observation phase follows the second intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None