NCT06633263

Combined Effect of TCC-I and BATD on Depressive Symptoms and Insomnia

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: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Liege · Academic / Other
• Sex: All
• Age: 18 Years – 67 Years
• Healthy volunteers: Not accepted

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 Alzheimer's 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 (e.g. 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.

Conditions

• Depression - Major Depressive Disorder
• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy for Insomnia	Introduce self-recording with the sleep diary; Introduce basic notions of insomnia; Introduce basic notions of sleep hygiene; Introduce basic notions of sleep; Recreate a time and place dedicated to sleep; Limit time spent in bed to time slept; Promote attitudes and beliefs that favor sleep and manage worries; Relapse prevention. This intervention is empirically validated (Morin, 2022).
BEHAVIORAL	Behavioral Activation Treatment for Depression	Introduce self-recording with daily activities; Introduce the basic concept of depression; Identify and increase activities associated with positive reinforcement; Reflect on life domains and values to identify reinforcing activities; Identify and decrease activities associated with negative reinforcement; Identify and decrease activities associated with negative reinforcement; Relapse prevention. This intervention is empirically validated (Ciharova et al., 2021)

Timeline

• Start date: 2024-10-21
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2024-10-09
• Last updated: 2024-11-01

Locations

1 site across 1 country: Belgium