Depression - Major Depressive DisorderNCT06633263
Combined Effect of TCC-I and BATD on Depressive Symptoms and Insomnia
A study testing Cognitive Behavioral Therapy for Insomnia and Behavioral Activation Treatment for Depression in people with Depression - Major Depressive Disorder and Insomnia, run by University of Liege at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Depression - Major Depressive Disorder, Insomnia
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia and Behavioral Activation Treatment for Depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Oct 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be adults with depression (PhQ 9 \> 10; cut-off for moderate depression) and insomnia (Insomnia Severity Index \> 11) who also meet DSM-V criteria for depression and insomnia (APA, 2013) and have a good understanding of French.
Who cannot join
- Participants requiring different treatment, i.e. those with symptoms suggestive of psychotic disorder, bipolar disorder, substance abuse disorder, excessive suicidal ideation, or other sleep pathology (such as sleep apnea, restless legs syndrome, narcolepsy, sleepwalking, or periodic limb movements)
- Participants who have recently received or are currently receiving other interventions that could be confused with our intervention, such as those undergoing treatment for sleep or depression, or those undergoing parallel psychological or pharmacological treatment (antidepressants and anxiolytics will be accepted provided they have been stabilized for at least two months and there are no planned changes in the following weeks).
- Participants with commitments that disrupt nocturnal sleep cycles and habits, such as those who no longer work or who work night shifts, will also be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
CPLU (clinique psychologique et logopédique de l université de Liège)
Liège, 4000
About this study
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
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.
Read the 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
- Being tested
- Cognitive Behavioral Therapy for Insomnia, Behavioral Activation Treatment for Depression
- Keywords
- depression, insomnia, CBT-I, BATD, combined intervention, multiple case study, Single Case Experimental Design
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
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 Activation Treatment for DepressionBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| CBT-I followed by BATD | Experimental | 1. Five group CBT-I sessions of two hours, one per week.
2. Two-week break - baseline
3. Five individual BATD sessions of one hour, one per week. Because of the diverse content of ruminations and avoidances in depression (Blairy et al., 2020), AC therapy will be administered in an individual format, while CBT-I will take place in a group setting. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: Behavioral Activation Treatment for Depression |
| BATD followed by CBT-I | Experimental | 1. Five individual BATD sessions of one hour, one per week. Because of the diverse content of ruminations and avoidances in depression (Blairy et al., 2020), AC therapy will be administered in an individual format, while CBT-I will take place in a group setting.
2. Two-week break - baseline
3. Five group CBT-I sessions of two hours, one per week. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: Behavioral Activation Treatment for Depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Generalised Anxiety Disorder Questionnaire. Scores ranges from 0 to 21. Higher scores means worse outcome (higher anxiety symptoms)
Measured: Six measures. Up to two weeks before the intervention, up to two weeks after the first intervention, up to two weeks after the second intervention, three months after the second intervention, six months after the second intervention, and two years after
Depression
Patient Health Questionnaire. Scores ranges from 0 to 27. Higher scores means worse outcome (higher depressive symptoms)
Measured: Six measures. Up to two weeks before the intervention, up to two weeks after the first intervention, up to two weeks after the second intervention, three months after the second intervention, six months after the second intervention, and two years after
Insomnia
Insomnia Severity Index. Scores ranges from 0 to 28. Higher scores means worse outcome (higher insomnia)
Measured: Six measures. Up to two weeks before the intervention, up to two weeks after the first intervention, up to two weeks after the second intervention, three months after the second intervention, six months after the second intervention, and two years after
Fatigue
Multidimensional Fatigue Inventory - General and physical fatigue. Scores ranges from 9 to 45. Higher scores means worse outcome (higher general and physical fatigue).
Measured: Six measures. Up to two weeks before the intervention, up to two weeks after the first intervention, up to two weeks after the second intervention, three months after the second intervention, six months after the second intervention, and two years after
Well-being
Well-being - Warwick-Edinburgh Mental Wellbeing Scale. Scores ranges from 14 to 70. Higher scores means better outcome (higher well-being)
Measured: Six measures. Up to two weeks before the intervention, up to two weeks after the first intervention, up to two weeks after the second intervention, three months after the second intervention, six months after the second intervention, and two years after
Socio-démographic Questionnaires
Age, gender, socio-economical status, situation at home
Measured: Up to two weeks before the intervention
Secondary outcomes (12)
Sleep Beliefs
Dysfunctional Beliefs and Attitudes about Sleep Scale. Scores ranges from 0 to 160. Higher scores means worse outcome (higher dysfunctional beliefs)
Measured: Six measures. Up to two weeks before the intervention, up to two weeks after the first intervention, up to two weeks after the second intervention, three months after the second intervention, six months after the second intervention, and two years after
Client satisfaction
Consumer Satisfaction Questionnaire. Scores ranges from 8 to 32. Higher scores means better outcome (higher satisfaction)
Measured: Two measures. up to two weeks after the first intervention, up to two weeks after the second intervention,
Activation
Activation level was collected daily at the end of the day in a booklet with the following item -I have been an active person and have accomplished the goals I set for myself- accompanied by a visual Analogue Scale (ranging from left side : not at all to right side completely). Scores ranges from 0 to 10. Higher scores means better outcome (higher behavioral activation)
Measured: Everyday through intervention completion (from week 1 up to 16 weeks later)
Rumination
Rumination level was collected daily at the end of the day in a booklet with the following item -I spent a lot of time dwelling on my problems- accompanied by a visual Analogue Scale (ranging from left side : not at all to right side completely). Scores ranges from 0 to 10. Higher scores means worse outcome (higher rumination)
Measured: Everyday through intervention completion (from week 1 up to 16 weeks later)
Anticipatory pleasure
Anticipatory pleasure level was collected daily at the end of the day in a booklet with the following item -I m looking forward to some upcoming events or activities- accompanied by a visual Analogue Scale (ranging from left side : not at all to right side completely). Scores ranges from 0 to 10. Higher scores means better outcome (higher anticipatory pleasure)
Measured: Everyday through intervention completion (from week 1 up to 16 weeks later)
Avoidance
Avoidance level was collected daily at the end of the day in a booklet with the following item -Most of the things I did were aimed at escaping or avoiding something unpleasant.- accompanied by a visual Analogue Scale (ranging from left side : not at all to right side completely). Scores ranges from 0 to 10. Higher scores means worse outcome (higher avoidance)
Measured: Everyday through intervention completion (from week 1 up to 16 weeks later)
Worry
Worry level was collected daily at the end of the day in a booklet with the following item -I worry about everything all the time- accompanied by a visual Analogue Scale (ranging from left side : not at all to right side completely). Scores ranges from 0 to 10. Higher scores means worse outcome (higher worry)
Measured: Everyday through intervention completion (from week 1 up to 16 weeks later)
Emotional reactivity
Emotional Reactivity level was collected daily at the end of the day in a booklet with the following item -I have found it difficult to cope emotionally with stressful situations or events that others might consider unimportant- accompanied by a visual Analogue Scale (ranging from left side : not at all to right side completely). Scores ranges from 0 to 10. Higher scores means worse outcome (higher emotional reactivity)
Measured: Everyday through intervention completion (from week 1 up to 16 weeks later)
Emotional reactivity 2
Emotional Reactivity 2 level was collected daily at the end of the day in a booklet with the following item -I have a tendency to react strongly, emotionally, to stressful situations or events that could have a negative impact on my sleep- accompanied by a visual Analogue Scale (ranging from left side : not at all to right side completely). Scores ranges from 0 to 10. Higher scores means worse outcome (higher emotional reactivity)
Measured: Everyday through intervention completion (from week 1 up to 16 weeks later)
Cognitive ressources - Focusing
Cognitive ressources level was collected daily at the end of the day in a booklet with the following item -It was easy for me to concentrate on a difficult task, even when there was noise all around- accompanied by a visual Analogue Scale (ranging from left side : not at all to right side completely). Scores ranges from 0 to 10. Higher scores means better outcome (better attentional focusing).
Measured: Everyday through intervention completion (from week 1 up to 16 weeks later)
Cognitive ressources - Flexibility
Cognitive ressources level was collected daily at the end of the day in a booklet with the following item -It was easy for me to alternate between two different tasks- accompanied by a visual Analogue Scale (ranging from left side : not at all to right side completely). Scores ranges from 0 to 10. Higher scores means better outcome (better attentional flexibility)
Measured: Everyday through intervention completion (from week 1 up to 16 weeks later)
Sleep quality
Sleep quality (Sleep onset latency, Total sleep Time, Wake after sleep onset, sleep efficiency) was collected daily via a sleep diary. Higher sleep onset latency and higher wake after sleep onset scores means a worse outcome, higher total sleep time and sleep efficiency means a better outcome
Measured: Everyday through intervention completion (from week 1 up to 16 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start21 Oct 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- In condition 1 : CBT-I precede BATD In condition 2 : BATD precede CBT-I Condition 1 is starting in Novembre Condition 2 is starting in February
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Liege
- Responsible party
- Principal investigator, Audrey Krings, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633263
- Sponsor's protocol ID
- 2024-313
- Status last verified
- Oct 2024
- First submitted
- 2 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD collected throughout the trial
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06633263
- Acronym / sponsor ID
- 2024-313
- Conditions
- Depression - Major Depressive Disorder, Insomnia
- Keywords
- depression, insomnia, CBT-I, BATD, combined intervention, multiple case study, Single Case Experimental Design
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Liege
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In condition 1 : CBT-I precede BATD In condition 2 : BATD precede CBT-I Condition 1 is starting in Novembre Condition 2 is starting in February
| Arm | Type | Receives |
|---|---|---|
| CBT-I followed by BATD | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia, Behavioral: Behavioral Activation Treatment for Depression1. Five group CBT-I sessions of two hours, one per week. 2. Two-week break - baseline 3. Five individual BATD sessions of one hour, one per week. Because of the diverse content of ruminations and avoidances in depression (Blairy et al., 2020), AC therapy will be administered in an individual format, while CBT-I will take place in a group setting. |
| BATD followed by CBT-I | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia, Behavioral: Behavioral Activation Treatment for Depression1. Five individual BATD sessions of one hour, one per week. Because of the diverse content of ruminations and avoidances in depression (Blairy et al., 2020), AC therapy will be administered in an individual format, while CBT-I will take place in a group setting. 2. Two-week break - baseline 3. Five group CBT-I sessions of two hours, one per week. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be adults with depression (PhQ 9 \> 10; cut-off for moderate depression) and insomnia (Insomnia Severity Index \> 11) who also meet DSM-V criteria for depression and insomnia (APA, 2013) and have a good understanding of French.
Key exclusion criteria (3 listed)
- Participants requiring different treatment, i.e. those with symptoms suggestive of psychotic disorder, bipolar disorder, substance abuse disorder, excessive suicidal ideation, or other sleep pathology (such as sleep apnea, restless legs syndrome, narcolepsy, sleepwalking, or periodic limb movements)
- Participants who have recently received or are currently receiving other interventions that could be confused with our intervention, such as those undergoing treatment for sleep or depression, or those undergoing parallel psychological or pharmacological treatment (antidepressants and anxiolytics will be accepted provided they have been stabilized for at least two months and there are no planned changes in the following weeks).
- Participants with commitments that disrupt nocturnal sleep cycles and habits, such as those who no longer work or who work night shifts, will also be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for InsomniaIntroduce 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). | Behavioural | BATD followed by CBT-I, CBT-I followed by BATD |
| Behavioral Activation Treatment for DepressionIntroduce 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) | Behavioural | BATD followed by CBT-I, CBT-I followed by BATD |
Primary outcome
Anxiety
Time frame: Six measures. Up to two weeks before the intervention, up to two weeks after the first intervention, up to two weeks after the second intervention, three months after the second intervention, six months after the second intervention, and two years after
Generalised Anxiety Disorder Questionnaire. Scores ranges from 0 to 21. Higher scores means worse outcome (higher anxiety symptoms)
Depression
Time frame: Six measures. Up to two weeks before the intervention, up to two weeks after the first intervention, up to two weeks after the second intervention, three months after the second intervention, six months after the second intervention, and two years after
Patient Health Questionnaire. Scores ranges from 0 to 27. Higher scores means worse outcome (higher depressive symptoms)
Insomnia
Time frame: Six measures. Up to two weeks before the intervention, up to two weeks after the first intervention, up to two weeks after the second intervention, three months after the second intervention, six months after the second intervention, and two years after
Insomnia Severity Index. Scores ranges from 0 to 28. Higher scores means worse outcome (higher insomnia)
Fatigue
Time frame: Six measures. Up to two weeks before the intervention, up to two weeks after the first intervention, up to two weeks after the second intervention, three months after the second intervention, six months after the second intervention, and two years after
Multidimensional Fatigue Inventory - General and physical fatigue. Scores ranges from 9 to 45. Higher scores means worse outcome (higher general and physical fatigue).
Well-being
Time frame: Six measures. Up to two weeks before the intervention, up to two weeks after the first intervention, up to two weeks after the second intervention, three months after the second intervention, six months after the second intervention, and two years after
Well-being - Warwick-Edinburgh Mental Wellbeing Scale. Scores ranges from 14 to 70. Higher scores means better outcome (higher well-being)
Socio-démographic Questionnaires
Time frame: Up to two weeks before the intervention
Age, gender, socio-economical status, situation at home
12 secondary outcomes
Sleep Beliefs
Time frame: Six measures. Up to two weeks before the intervention, up to two weeks after the first intervention, up to two weeks after the second intervention, three months after the second intervention, six months after the second intervention, and two years after
Client satisfaction
Time frame: Two measures. up to two weeks after the first intervention, up to two weeks after the second intervention,
Activation
Time frame: Everyday through intervention completion (from week 1 up to 16 weeks later)
Rumination
Time frame: Everyday through intervention completion (from week 1 up to 16 weeks later)
Anticipatory pleasure
Time frame: Everyday through intervention completion (from week 1 up to 16 weeks later)
Avoidance
Time frame: Everyday through intervention completion (from week 1 up to 16 weeks later)
Worry
Time frame: Everyday through intervention completion (from week 1 up to 16 weeks later)
Emotional reactivity
Time frame: Everyday through intervention completion (from week 1 up to 16 weeks later)
Emotional reactivity 2
Time frame: Everyday through intervention completion (from week 1 up to 16 weeks later)
Cognitive ressources - Focusing
Time frame: Everyday through intervention completion (from week 1 up to 16 weeks later)
Cognitive ressources - Flexibility
Time frame: Everyday through intervention completion (from week 1 up to 16 weeks later)
Sleep quality
Time frame: Everyday through intervention completion (from week 1 up to 16 weeks later)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- pré-registration and dataLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all IPD collected throughout the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia and Behavioral Activation Treatment for Depression in people with Depression - Major Depressive Disorder and Insomnia, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Six measures. Up to two weeks before the intervention, up to two weeks after the first intervention, up to two weeks after the second intervention, three months after the second intervention, six months after the second intervention, and two years after). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.