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

NCT06633263 | Enrolling By Invitation

• 1 other identifier: 2024-313
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression - Major Depressive Disorder; Insomnia

Keywords

depression; insomnia; CBT-I; BATD; combined intervention; multiple case study; Single Case Experimental Design

Outcome Measures

Primary Outcomes (6)

• Anxiety

  Generalised Anxiety Disorder Questionnaire. Scores ranges from 0 to 21. Higher scores means worse outcome (higher anxiety symptoms)

  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)

  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)

  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).

  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)

  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

  Up to two weeks before the intervention

Secondary Outcomes (12)

• Sleep Beliefs

  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

  Two measures. up to two weeks after the first intervention, up to two weeks after the second intervention,

• Activation

  Everyday through intervention completion (from week 1 up to 16 weeks later)

• Rumination

  Everyday through intervention completion (from week 1 up to 16 weeks later)

• Anticipatory pleasure

  Everyday through intervention completion (from week 1 up to 16 weeks later)

Other Outcomes (1)

• Qualitative Interview

  Three measures. Up to two weeks before the intervention, up to two weeks after the first intervention, up to two weeks after the second intervention

Study Arms (2)

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.

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.

Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: Behavioral Activation Treatment for Depression

Interventions

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

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).

BATD followed by CBT-I; CBT-I followed by BATD

Behavioral Activation Treatment for Depression BEHAVIORAL

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)

BATD followed by CBT-I; CBT-I followed by BATD

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Liege: lead
• Centre Hospitalier Universitaire de Liege: collaborator

Study Sites (1)

CPLU (clinique psychologique et logopédique de l université de Liège)

Liège, 4000, Belgium

Location

Related Links

• pré-registration and data

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 9, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Beginning after publication with no end date
• Access Criteria: meta-analysis and that must be approved by the investigator

Locations

BE (1)