search
Back to results

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

Primary Purpose

Mental Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental: experimental wellbeing promotion group (Think and Cope Positively)
TAU
Sponsored by
Universidad Pontificia Comillas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorder focused on measuring Schizophrenia, Subjective Well-Being, Optimism, Coping, Purpose of life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

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

    TAU + waiting list

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    September 5, 2023
    Last Updated
    September 21, 2023
    Sponsor
    Universidad Pontificia Comillas
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06054061
    Brief Title
    Evaluation the Efficacy "Think and Cope Positively" Program
    Acronym
    PA+
    Official Title
    Improving Subjective Wellbeing Despite a Severe Psychiatric Condition Through "Think and Cope Positively" Program: A Randomized Control Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 20, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2025 (Anticipated)
    Study Completion Date
    September 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Pontificia Comillas

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Disorder
    Keywords
    Schizophrenia, Subjective Well-Being, Optimism, Coping, Purpose of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    168 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TAU + Wellbeing promotion group (Think and Cope Positively) Intervention
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    TAU + waiting list
    Arm Type
    Other
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Experimental: experimental wellbeing promotion group (Think and Cope Positively)
    Intervention Description
    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
    Intervention Name(s)
    TAU
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Satisfaction with life scale (SWLS)
    Description
    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.
    Time Frame
    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.
    Title
    Psychological Well-being Scale (SPWB)
    Description
    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.
    Time Frame
    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 Measure Information:
    Title
    Openness to the Future Scale (OFS)
    Description
    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.
    Time Frame
    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.
    Title
    Therapeutic Alliance and Theory of Change Inventory (WATOCI)
    Description
    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.
    Time Frame
    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.
    Title
    Symptom Checklist-45 abbreviated version
    Description
    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.
    Time Frame
    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 Pre-specified Outcome Measures:
    Title
    Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
    Description
    This scale enable the monitoring of mental wellbeing in the general population and is frequently used in evaluation of projects, programs and policies which aim to improve mental wellbeing. The scale presented seven items, answered in a 5-point Likert scale from 1 to 5 (never - always or almost always). Mean scores range from 1 to 5. Higher scores indicates higher wellbeing.
    Time Frame
    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.
    Title
    Clinical Outcomes in Routine Evaluation-Outcome Measure-5 (CORE-OM)
    Description
    The brief form of the CORE-OM assesses psychological distress by 5 items, which present a 5-points Likert-type scale from 0 to 4 (never - always or almost always). Mean scores range from 0 to 4. Higher scores indicates higher psychological distress.
    Time Frame
    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.
    Title
    Protocol adherence form
    Description
    At the end of each session, the group therapists fill out a 10-item inventory in which they indicate the fulfillment of the session's objectives using a 3-points Likert scale 0 to 2 (not achieved - partially achieved - fully achieved).
    Time Frame
    This record is applied by the therapist at the end of each of the 15 intervention sessions
    Title
    Attendance and exercise engagement form
    Description
    At the end of each session, the therapists record the participants who attended the session and the performance of the exercises at home before the session and in the session.
    Time Frame
    This record is applied by the therapist at the end of each of the 15 intervention sessions
    Title
    Participants' satisfaction was measured by the Client Satisfaction Questionnaire (CSQ-8, Larsen et al., 1979).
    Description
    The CSQ-8 is an 8-item measure that assessed general satisfaction with the group by a 4-points Likert-type scale from 1 to 4 (very dissatisfied - very satisfied). Mean scores range from 1 to 4. Higher scores indicate higher satisfaction.
    Time Frame
    This register is applied at the end of the 15-week intervention period.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Evaluation the Efficacy "Think and Cope Positively" Program

    We'll reach out to this number within 24 hrs