Evaluation the Efficacy "Think and Cope Positively" Program

NCT06054061 | Completed

• 2 other identifiers: 7/22-23CX22-00110
• Study Type: interventional
• Target: 449
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorder

Keywords

Schizophrenia; Subjective Well-Being; Optimism; Coping; Purpose of life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Openness to the Future Scale (OFS)

  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 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 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 (5)

• Warwick-Edinburgh Mental Well-being Scale (WEMWBS)

  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.

• Clinical Outcomes in Routine Evaluation-Outcome Measure-5 (CORE-OM)

  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.

• Protocol adherence form

  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

Study Arms (2)

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

EXPERIMENTAL

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); Behavioral: TAU

TAU + waiting list

OTHER

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

Interventions

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

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

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Pontificia Comillas: lead

Study Sites (1)

UNINPSI

Madrid, Madrid, 28036, Spain

Location

MeSH Terms

Conditions

Mental Disorders; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Rocío Caballero-Campillo, Dra

  UNINPSI, Universidad Pontificia Comillas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Collaborator - Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 26, 2023
• Study Start: September 20, 2023
• Primary Completion: November 1, 2023
• Study Completion: May 1, 2025
• Last Updated: April 28, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)