Evaluation the Efficacy "Think and Cope Positively" Program

NCT ID: NCT06054061

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 449 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-20
• Study Completion Date: 2025-09-30

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.

Conditions

Mental Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

TAU

Intervention Type: BEHAVIORAL

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.

TAU + waiting list

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.

Group Type: OTHER

TAU

Intervention Type: BEHAVIORAL

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.

Interventions

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

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.

Intervention Type: BEHAVIORAL

TAU

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Pontificia Comillas

OTHER

Sponsor Role: lead

Responsible Party

Rocio Caballero Campillo

Assistant Collaborator - Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rocío Caballero-Campillo, Dra

Role: PRINCIPAL_INVESTIGATOR

UNINPSI, Universidad Pontificia Comillas

Locations

UNINPSI

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

CX22-00110

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

7/22-23

Identifier Type: -

Identifier Source: org_study_id