Intervention Targeting Motivational Negative Symptoms

Schizophrenia Clinical Trial

— Switch  

Official title:

Development and Validation of an Intervention Targeting Motivational Negative Symptoms: Switch Protocol 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325100
• Other study ID #: B707201629105
• Status: Completed
• Phase: N/A
• Start date: April 20, 2019
• Est. completion date: February 27, 2020

Study information

• Verified date: March 2020
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 27, 2020
• Est. primary completion date: December 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bipolar Disorder
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Mood Disorders
• Psychotic Disorders
• Schizo Affective Disorder
• Schizophrenia

Intervention

Behavioral:
• Switch - Individual sessions
Participants follow the Switch intervention through individual sessions (1 hour, twice a week, for around 2 months). Participants are provided with a folder which presents the rational for each strategy. Take-home assignments are given and stored in the same folder. Participants are also given small cards (that can fit in their wallet) containing the key elements of each strategy. The intervention manual can be obtained from the main investigator (in French).
• Switch - Group programme
Participants follow the Switch group programme (2 hours, twice a week, for around 2 months). During the group sessions, a powerpoint presentation and different media are used to present the different parts of the motivation model. Participants learn the different strategies (e.g., cognitive defusion, pleasure anticipation, problem solving) through individual and group exercises. Participants are provided with a folder which presents the rational for each strategy. Take-home assignments are given and stored in the same folder. Participants are also given small cards (that can fit in their wallet) containing the key elements of each strategy. The intervention manual and the presentation material can be obtained from the main investigator (in French).

Locations

Country	Name	City	State
Belgium	University of Liege	Liège

Sponsors (2)

Lead Sponsor	Collaborator
University of Liege	FNRS

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Negative Symptom Scale (BNSS)	There are 13 items that are scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe). The Expressive deficit factor includes the following subscales: Blunted affect (facial expression, vocal expression, expressive gestures) and Alogia (quantity of speech, spontaneous elaboration).Each item is scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe).	Baseline
Primary	Brief Negative Symptom Scale (BNSS)	There are 13 items that are scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe). The Expressive deficit factor includes the following subscales: Blunted affect (facial expression, vocal expression, expressive gestures) and Alogia (quantity of speech, spontaneous elaboration).Each item is scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe).	2 months (post intervention)
Primary	Brief Negative Symptom Scale (BNSS)	There are 13 items that are scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe). The Expressive deficit factor includes the following subscales: Blunted affect (facial expression, vocal expression, expressive gestures) and Alogia (quantity of speech, spontaneous elaboration).Each item is scored from 0 to 6 (0 = no impairment; 1 = very slight; 2 = mild; 3 = moderate; 4 = moderately severe; 5 = marked; 6 = severe).	6 months (follow-up)
Primary	Lille Apathy Rating Scale (patient version) (LARS-p)	The LARS is a semi-structured interview designed to evaluate the different dimensions (cognitive, emotional and behavioural) of apathy in schizophrenia, through the following subscales: Everyday productivity, Interests, Taking initiatives, Novelty seeking, Voluntary actions, Emotional responses, Concern, Social life and Self-awareness. The total score ranges from -36 to 36 ([-36; -22] = absence of apathy; [-21; -17] = tendency towards apathy; [-16; -10] = moderate apathy; [-9; 36] = severe apathy).	Baseline
Primary	Lille Apathy Rating Scale (patient version) (LARS-p)	The LARS is a semi-structured interview designed to evaluate the different dimensions (cognitive, emotional and behavioural) of apathy in schizophrenia, through the following subscales: Everyday productivity, Interests, Taking initiatives, Novelty seeking, Voluntary actions, Emotional responses, Concern, Social life and Self-awareness. The total score ranges from -36 to 36 ([-36; -22] = absence of apathy; [-21; -17] = tendency towards apathy; [-16; -10] = moderate apathy; [-9; 36] = severe apathy).	2 months (post-intervention)
Primary	Lille Apathy Rating Scale (informant version) (LARS-i)	The LARS is a semi-structured interview designed to evaluate the different dimensions (cognitive, emotional and behavioural) of apathy in schizophrenia, through the following subscales: Everyday productivity, Interests, Taking initiatives, Novelty seeking, Voluntary actions, Emotional responses, Concern, Social life and Self-awareness. The total score ranges from -36 to 36 ([-36; -22] = absence of apathy; [-21; -17] = tendency towards apathy; [-16; -10] = moderate apathy; [-9; 36] = severe apathy).	6 months (follow-up)
Primary	Schizophrenia - Quality of Life questionnaire	The S-QoL is a 41-item questionnaire that evaluates life satisfaction regarding psychological wellbeing, self-esteem, family relationships, relationships with friends, resilience, physical wellbeing, autonomy and sentimental life. Items are rated on a 5-point Likert scale (1 = much less satisfied than expected; 2 = less satisfied; 3 = slightly less satisfied; 4 = as satisfied; 5 = more satisfied). The total score ranges from 0 to 100, higher scores indicating better subjective quality of life.	Baseline (month 0)
Primary	Schizophrenia - Quality of Life questionnaire	The S-QoL is a 41-item questionnaire that evaluates life satisfaction regarding psychological wellbeing, self-esteem, family relationships, relationships with friends, resilience, physical wellbeing, autonomy and sentimental life. Items are rated on a 5-point Likert scale (1 = much less satisfied than expected; 2 = less satisfied; 3 = slightly less satisfied; 4 = as satisfied; 5 = more satisfied). The total score ranges from 0 to 100, higher scores indicating better subjective quality of life.	2 months (post-intervention)
Primary	Schizophrenia - Quality of Life questionnaire	The S-QoL is a 41-item questionnaire that evaluates life satisfaction regarding psychological wellbeing, self-esteem, family relationships, relationships with friends, resilience, physical wellbeing, autonomy and sentimental life. Items are rated on a 5-point Likert scale (1 = much less satisfied than expected; 2 = less satisfied; 3 = slightly less satisfied; 4 = as satisfied; 5 = more satisfied). The total score ranges from 0 to 100, higher scores indicating better subjective quality of life.	6 months (follow-up)
Primary	Functional Remission of General Schizophrenia (FROGS)	The FROGS is a measure of daily life outcomes, which evaluates level of functioning in 5 different domains: Daily life, Activities, Relationships, Quality of adaptation, and Health and treatment. The total score ranges from 19 to 95. The threshold score for remission is 61.	Baseline
Primary	Functional Remission of General Schizophrenia (FROGS)	The FROGS is a measure of daily life outcomes, which evaluates level of functioning in 5 different domains: Daily life, Activities, Relationships, Quality of adaptation, and Health and treatment. The total score ranges from 19 to 95. The threshold score for remission is 61.	2 months (post-intervention)
Primary	Functional Remission of General Schizophrenia (FROGS)	The FROGS is a measure of daily life outcomes, which evaluates level of functioning in 5 different domains: Daily life, Activities, Relationships, Quality of adaptation, and Health and treatment. The total score ranges from 19 to 95. The threshold score for remission is 61.	6 months (follow-up)
Secondary	Experience Sampling Method	Questionnaire including 14 questions regarding mood, discouraging beliefs, coping, confidence, motivation, energy, social environment, current activity, initiation, present enjoyment, activity's meaning, effort, reminiscence, projection into the future. The questionnaires are sent 3 times (intervention phase) or 5 times per day (baseline, post-intervention and follow-up phases).	Baseline (14 days): 5 triggers/day
Secondary	Experience Sampling Method	Questionnaire including 14 questions regarding mood, discouraging beliefs, coping, confidence, motivation, energy, social environment, current activity, initiation, present enjoyment, activity's meaning, effort, reminiscence, projection into the future. The questionnaires are sent 3 times (intervention phase) or 5 times per day (baseline, post-intervention and follow-up phases).	Intervention phase (60 days): 3 triggers/day
Secondary	Experience Sampling Method	Questionnaire including 14 questions regarding mood, discouraging beliefs, coping, confidence, motivation, energy, social environment, current activity, initiation, present enjoyment, activity's meaning, effort, reminiscence, projection into the future. The questionnaires are sent 3 times (intervention phase) or 5 times per day (baseline, post-intervention and follow-up phases).	Post-intervention (14 days): 5 triggers/day
Secondary	Experience Sampling Method	Questionnaire including 14 questions regarding mood, discouraging beliefs, coping, confidence, motivation, energy, social environment, current activity, initiation, present enjoyment, activity's meaning, effort, reminiscence, projection into the future. The questionnaires are sent 3 times (intervention phase) or 5 times per day (baseline, post-intervention and follow-up phases).	Follow-up (14 days): 5 triggers/day
Secondary	Step count	Daily step count (total per day) via an activity band.	Baseline (14 days): 5 triggers/day
Secondary	Step count	Daily step count (total per day) via an activity band.	Intervention phase (60 days): 3 triggers/day
Secondary	Step count	Daily step count (total per day) via an activity band.	Post-intervention (14 days): 5 triggers/day
Secondary	Step count	Daily step count (total per day) via an activity band.	Follow-up (14 days): 5 triggers/day