Clinical trial NCT06054061: Evaluation the Efficacy "Think and Cope Positively" Program
Official title: Improving Subjective Wellbeing Despite a Severe Psychiatric Condition Through "Think and Cope Positively" Program: A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Disorder
Keywords: Schizophrenia
Subjective Well-Being
Optimism
Coping
Purpose of life
Lead sponsor: Universidad Pontificia Comillas
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 449
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicenter cluster randomized clinical trial will be conducted. The trial will consist of two arms, the experimental group will receive a 15-week intervention based on the promotion of hedonic and eudaimonic well-being. The control group will remain on a waitlist with their Treatment as Usual. Participants will be recruited from centers that focus on the psychosocial rehabilitation of people diagnosed with schizophrenia spectrum, bipolar disorder, personality disorders and severe affective disorders. Random allocation to the groups will be stratified according to the typology of the center. In the event that there is only a single representative of one of the center typologies, the entire center will be assigned to one of the study conditions. Assessments will be made before the intervention (E1), immediately after the 15-week intervention period (E2) and three (E3) and six (E4) months after the end of the intervention.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether an integrated protocol based on cognitive behavioural therapy, positive psychology and third generation therapies is effective in improve the subjective well-being of people affected by a severe mental illness (SMI).

The design of the study is a cluster randomized control trial with two arms. Experimental groups will receive 15 sessions to enhance positive emotions, optimism, adaptive coping, finding a purpose in life and sharing it with people who are important to the user. The control group will remain on a waitlist with their treatment as usual (TAU). After the control period (15 weeks), participants of the experimental groups have the chance to receive the intervention. Both groups will be measure before and after de 15 intervention weeks. Additionally, follow-up measures of the experimental group will be taken after 3 and 6 months.

Detailed description: This research aims to generate evidence on the usefulness of interventions focused on the well-being of people diagnosed with SMI, trying to alleviate some of the limitations found in previous protocols.

Regarding the content of the sessions, optimism, low levels of depression, social support and the degree of agreement with the therapist, have recently been identified as the factors that best predict subjective well-being in people affected by SMI. Therefore, modules on optimism and coping focused on well-being will be included, maintaining the emphasis of the work on positive emotions. By adding an individual work session in which goals and objectives are agreed upon by the therapist and user, the consensus will be strengthened between both parties. After discussing the construction of a life project throughout the protocol, the process the process will conclude with a session combined users and the special persons chosen by the participants. Both members will have the opportunity to share with each other.

Finally, we will follow the indications of recent studies which demonstrate that, in order to improve the optimistic response in psychiatric populations, it is necessary to reformulate negative thinking, practice hopeful thinking, practice gratitude and build a life project.

Eligibility criteria: Inclusion Criteria:

* Users of public psychosocial rehabilitation resources belonging to the Community of Madrid and Castilla la Mancha
* Legal age
* Clinical diagnosis of severe mental disorder: schizophrenia spectrum, bipolar disorder, personality disorders and severe affective disorders.
* Psychopathological stability (or that residual symptoms do not interfere with the course of treatment)
* Minimum level of cognitive comprehension (i.e. no comorbidity with intellectual disability).

Exclusion Criteria:

* Addiction dependence criteria (on the other hand, people with substance abuse criteria will be accepted)
* Altered behavior (relationally) that could alter the good functioning of the group.

Prior to their participation in the study, the rehabilitation team, in coordination with the research team, will assess whether the patient can benefit from the study.

Primary outcomes:
measure: Satisfaction with life scale (SWLS)
timeFrame: This test is applied before starting the intervention protocol, immediately after the end of the 15-week intervention protocol, and at 3 and 6 months after the end of the intervention protocol.
measure: Psychological Well-being Scale (SPWB)
timeFrame: This test is applied before starting the intervention protocol, immediately after the end of the 15-week intervention protocol, and at 3 and 6 months after the end of the intervention protocol.
Secondary outcomes:
measure: Openness to the Future Scale (OFS)
timeFrame: This test is applied before starting the intervention protocol, immediately after the end of the 15-week intervention protocol, and at 3 and 6 months after the end of the intervention protocol.
measure: Therapeutic Alliance and Theory of Change Inventory (WATOCI)
timeFrame: This test is applied before starting the intervention protocol, immediately after the end of the 15-week intervention protocol, and at 3 and 6 months after the end of the intervention protocol.
measure: Symptom Checklist-45 abbreviated version
timeFrame: This test is applied before starting the intervention protocol, immediately after the end of the 15-week intervention protocol, and at 3 and 6 months after the end of the intervention protocol.
Other outcomes:
measure: Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
timeFrame: This test is applied before starting the intervention protocol, at the end of each of the 15 intervention sessions, immediately after the end of the 15-week intervention protocol, and at 3 and 6 months after the end of the intervention protocol.
measure: Clinical Outcomes in Routine Evaluation-Outcome Measure-5 (CORE-OM)
timeFrame: This test is applied before starting the intervention protocol, at the end of each of the 15 intervention sessions, immediately after the end of the 15-week intervention protocol, and at 3 and 6 months after the end of the intervention protocol.
measure: Protocol adherence form
timeFrame: This record is applied by the therapist at the end of each of the 15 intervention sessions. This measure will be carried out after each treatment session assessed up to 24 months
measure: Attendance and exercise engagement form
timeFrame: This record is applied by the therapist at the end of each of the 15 intervention sessions. This measure will be carried out after each treatment session assessed up to 24 months
measure: Participants' satisfaction was measured by the Client Satisfaction Questionnaire (CSQ-8, Larsen et al., 1979).
timeFrame: This register is applied at the end of the 15-week intervention period.
Locations:
city: Madrid
country: Spain
facility: UNINPSI
state: Comunidad Autonoma De Madrid
Study officials:
affiliation: UNINPSI, Universidad Pontificia Comillas
name: Rocío Caballero-Campillo, Dra
role: PRINCIPAL_INVESTIGATOR
References: