Evaluation the Efficacy Think and Cope Positively Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Subjective Wellbeing Despite a Severe Psychiatric Condition Through Think and Cope Positively Program: A Randomized Control Trial.

Conditions
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Mental Disorder

Intervention / Treatment
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* Behavioral: Experimental: experimental wellbeing promotion group (Think and Cope Positively)
* Behavioral: TAU


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAU + Wellbeing promotion group (Think and Cope Positively) Intervention<br>In addition to their usual treatment, participants form the experimental arm will receive 15 weekly intervention sessions, where aspects related to subjective wellbeing, life plans, alliance with the therapist or family and social relationships will be worked on. | Behavioral: Experimental: experimental wellbeing promotion group (Think and Cope Positively)<br>* Session 1: Welcome. 2: Identifying and amplifying positive emotions. 3: Experiencing positive emotions. 4: Identifying my negative trap thoughts. 5: Transforming my automatic thoughts into positive ones. Session 6: Experiencing my positive thoughts I. 7: Experiencing my positive thoughts II. 8: Learning to be kinder to myself. 9: Identifying a life project (Individual appointment).10: Identifying coping strategies I. 11: Identifying coping strategies II. 12: Identifying adaptive coping strategies linked to well-being. 13: Building my life purpose with my environment. 14: Helping me to build my life purpose? 15: Multi-family session, farewell and closing.<br>Behavioral: TAU<br>* The usual treatment in the intervention of people affected by severe mental disorder in the network of public and subsidized centers in Spain consists of improving psychosocial functioning. To this end, and depending on the characteristics of the user, work is done in groups and individually on social skills, psychoeducation about the disease, adherence to pharmacological treatment, improvement of daily living activities, promotion of independent leisure, support to families in the process of relapse prevention, and training for labor market insertion.<br>|
| Other: TAU + waiting list<br>The control group will continue to receive the treatment as usual in their intervention resources. At the end of the 15-week control period they will receive the intervention. | Behavioral: TAU<br>* The usual treatment in the intervention of people affected by severe mental disorder in the network of public and subsidized centers in Spain consists of improving psychosocial functioning. To this end, and depending on the characteristics of the user, work is done in groups and individually on social skills, psychoeducation about the disease, adherence to pharmacological treatment, improvement of daily living activities, promotion of independent leisure, support to families in the process of relapse prevention, and training for labor market insertion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with life scale (SWLS) | The scale evaluate hedonic well-being by 5 items with a 7-point Likert-type response scale (strongly disagree - strongly agree). Mean scores range from 1 to 5. Higher scores indicates higher hedonic well being. | 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. | 
| Psychological Well-being Scale (SPWB) | The scale evaluate eudaemonic well-being by 29 items with a Likert-type scale from 1 to 6 (totally disagree - totally agree). The scale measures 6 domains of well being (self-acceptance, purpose in life, personal growth, positive relationships, autonomy and mastery of the environment). Mean scores range from 1 to 6. Higher scores indicates higher eudaemonic well being or domain. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Openness to the Future Scale (OFS) | This scale evaluate optimism conceptualized as a positive affective state by 10 items with a Likert-type scale from 1 to 6 (totally disagree - totally agree). Mean scores range from 1 to 6. Higher scores indicates higher optimism. | 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. | 
| Therapeutic Alliance and Theory of Change Inventory (WATOCI) | This scale evaluate the alliance with the therapist by 17 items with a Likert-type scale from 1 to 7 (never - always). Mean scores range from 1 to 7. Higher score indicates higher alliance with the therapist. | 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. | 
| Symptom Checklist-45 abbreviated version | This test evaluates psychological symptom by 45-items with a Likert-type scale from 0 to 4 (Not at all - Very much or extremely). The scale evaluates 9 domains (Depression, Hostility, Interpersonal sensitivity, Somatization, Anxiety, Psychoticism, Obsession-Compulsion, Phobic anxiety and, Paranoid ideation). Mean scores range from 0 to 4. A higher score indicates more intense symptoms. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Subjective Well-Being, Optimism, Coping, Purpose of life