Evaluation the Efficacy "Think and Cope Positively" Program (PA+)

Universidad Pontificia Comillas

Status: Active, not recruiting

Conditions: Mental Disorder

Treatments: Behavioral: TAU; Behavioral: Experimental: experimental wellbeing promotion group (Think and Cope Positively)

Study type: Interventional

Funder types: Other

Identifiers

NCT06054061

7/22-23

CX22-00110 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 449 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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449 participants in 2 patient groups

TAU + Wellbeing promotion group (Think and Cope Positively) Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Experimental: experimental wellbeing promotion group (Think and Cope Positively)

Behavioral: TAU

TAU + waiting list

Other group

Description:

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.

Treatment:

Behavioral: TAU