Clinical trial NCT04325100: Intervention Targeting Motivational Negative Symptoms
Official title: Development and Validation of an Intervention Targeting Motivational Negative Symptoms: Switch Protocol 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizo Affective Disorder
Bipolar Disorder
Major Depressive Disorder
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: Fonds National de la Recherche Scientifique
First posted: 2020-03-27
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effects of the Switch intervention on motivation and associated processes and explore the dynamics between the processes.

A single case approach is followed, with a pre-post and follow-up assessment design, and continuous ambulatory assessments (experience sampling method (ESM) and step count).

Detailed description: Motivational negative symptoms hinder quality of life and daily functioning of individuals with schizophrenia spectrum, bipolar and major depressive disorders.

A recently developed intervention, Switch, has shown promising effects on negative symptoms and functional outcomes. Switch is based on a model that identifies various cognitive, behavioural and emotional processes related to motivation and goal-directed behaviours: pleasure anticipation, value-effort-probability computation, (dys)functional attitudes (e.g., discouraging thoughts, self-efficacy), planning, initiation, in-the-moment enjoyment, reminiscence. The intervention combines a person-centred and recovery approach with cognitive, behavioural and 3rd wave techniques to tackle the obstacles related to motivation and goal-directed behaviours (i.e., targetting the various cognitive, behavioural and emotional processes listed above). Thus, an important part of the intervention focuses on the person's strengths, needs, goals and values. Furthermore, various strategies (e.g., cognitive defusion, pleasure anticipation, problem solving, reminiscence) are used to encourage engagement in meaningful personal goals and values.

The Switch intervention is provided either in individual (one-hour sessions), or in a group setting (two-hour sessions), twice a week for around two months.

There are three types of evaluation: traditional assessment scales of motivational deficits, apathy, quality of life and daily functioning (pre, post and follow-up at 3 months); ambulatory assessment including ESM (i.e., daily questionnaires); actigraphy (step count).

The aims of this study is to evaluate the efficacy of Switch in two different settings (i.e., individual sessions and a group programme) on motivation/apathy and functional outcomes/quality of life. Furthermore, we wish to explore the effects of Switch on process related to motivation and goal-directed behaviours (e.g., pleasure anticipation, reminiscence, defeatist beliefs, activities' meaningfulness) and on activity (i.e., step count). Finally, we wish to evaluate the dynamics between the different cognitive, behavioural and emotional processes related to motivation and goal-directed behaviours.

Eligibility criteria: Inclusion Criteria:

* Diagnostic and Statistical Manual-V (DSM-V) criteria for schizophrenia, schizoaffective, bipolar or major depressive disorder (American Psychiatric Association, 2013).
* Good understanding of French.

Exclusion Criteria:

* Presenting an unstable clinical picture;
* Evidence of a significant change in medication within one month prior to baseline assessment;
* Having a history of severe brain trauma or epilepsy;
* Comorbid intellectual disability;
* Moderate or severe substance use disorder other than tobacco (according to the DSM-V; i.e., showing 4 or more symptoms).

Primary outcomes:
measure: Brief Negative Symptom Scale (BNSS)
timeFrame: Baseline
measure: Brief Negative Symptom Scale (BNSS)
timeFrame: 2 months (post intervention)
measure: Brief Negative Symptom Scale (BNSS)
timeFrame: 6 months (follow-up)
measure: Lille Apathy Rating Scale (patient version) (LARS-p)
timeFrame: Baseline
measure: Lille Apathy Rating Scale (patient version) (LARS-p)
timeFrame: 2 months (post-intervention)
measure: Lille Apathy Rating Scale (informant version) (LARS-i)
timeFrame: 6 months (follow-up)
measure: Schizophrenia - Quality of Life questionnaire
timeFrame: Baseline (month 0)
measure: Schizophrenia - Quality of Life questionnaire
timeFrame: 2 months (post-intervention)
measure: Schizophrenia - Quality of Life questionnaire
timeFrame: 6 months (follow-up)
measure: Functional Remission of General Schizophrenia (FROGS)
timeFrame: Baseline
measure: Functional Remission of General Schizophrenia (FROGS)
timeFrame: 2 months (post-intervention)
measure: Functional Remission of General Schizophrenia (FROGS)
timeFrame: 6 months (follow-up)
Secondary outcomes:
measure: Experience Sampling Method
timeFrame: Baseline (14 days): 5 triggers/day
measure: Experience Sampling Method
timeFrame: Intervention phase (60 days): 3 triggers/day
measure: Experience Sampling Method
timeFrame: Post-intervention (14 days): 5 triggers/day
measure: Experience Sampling Method
timeFrame: Follow-up (14 days): 5 triggers/day
measure: Step count
timeFrame: Baseline (14 days): 5 triggers/day
measure: Step count
timeFrame: Intervention phase (60 days): 3 triggers/day
measure: Step count
timeFrame: Post-intervention (14 days): 5 triggers/day
measure: Step count
timeFrame: Follow-up (14 days): 5 triggers/day
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University of Liege
Study officials:
affiliation: University of Liege
name: Frank Laroi, PhD
role: STUDY_DIRECTOR
References:
citation: Thonon B, Van Aubel E, Lafit G, Della Libera C, Laroi F. Idiographic analyses of motivation and related processes in participants with schizophrenia following a therapeutic intervention for negative symptoms. BMC Psychiatry. 2020 Sep 25;20(1):464. doi: 10.1186/s12888-020-02824-5.