Intervention Targeting Motivational Negative Symptoms

NCT04325100 | Completed

• 1 other identifier: B707201629105
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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).

Conditions

Schizophrenia; Schizo Affective Disorder; Bipolar Disorder; Major Depressive Disorder

Outcome Measures

Primary Outcomes (12)

• 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

• 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)

• 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)

• 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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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

• 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)

• 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 Outcomes (8)

• Experience Sampling Method

  Baseline (14 days): 5 triggers/day

• Experience Sampling Method

  Intervention phase (60 days): 3 triggers/day

• Experience Sampling Method

  Post-intervention (14 days): 5 triggers/day

• Experience Sampling Method

  Follow-up (14 days): 5 triggers/day

• Step count

  Baseline (14 days): 5 triggers/day

Study Arms (2)

Switch - i

EXPERIMENTAL

Individual sessions

Behavioral: Switch - Individual sessions

Switch - g

EXPERIMENTAL

Group programme

Behavioral: Switch - Group programme

Interventions

Switch - Individual sessions BEHAVIORAL

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 - i

Switch - Group programme BEHAVIORAL

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).

Switch - g

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Liege: lead
• Fonds National de la Recherche Scientifique: collaborator

Study Sites (1)

University of Liege

Liège, 4000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 32977798 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder

Study Officials

• Frank Laroi, PhD

  University of Liege

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: A blinding procedure was used for the evaluation of the Brief Negative Symptom Scale: interviews were recorded and each video or sound recording was evaluated at the end of the study by one (or two) independent evaluator who was unaware of the recordings' assessment time.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 27, 2020
• Study Start: April 20, 2019
• Primary Completion: December 6, 2019
• Study Completion: February 27, 2020
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

BE (1)