Mental DisorderPA+NCT06054061
Evaluation the Efficacy "Think and Cope Positively" Program
A study testing Experimental: experimental wellbeing promotion group (Think and Cope Positively) and TAU in people with Mental Disorder, run by Universidad Pontificia Comillas at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Disorder
- What is being tested?
- Experimental: experimental wellbeing promotion group (Think and Cope Positively) and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 449 participants
- Where
- 1 siteSpain
- Study dates
- 20 Sep 2023to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Improving Subjective Wellbeing Despite a Severe Psychiatric Condition Through "Think and Cope Positively" Program: A Randomized Control Trial.
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.
Read the 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
- Being tested
- Experimental: experimental wellbeing promotion group (Think and Cope Positively), TAU
- Keywords
- Schizophrenia, Subjective Well-Being, Optimism, Coping, Purpose of life
- Medical subject headings
- Mental Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: experimental wellbeing promotion group (Think and Cope Positively)Behavioural
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.
TAUBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start20 Sep 2023
- Primary completion1 Nov 2023
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Pontificia Comillas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocio Caballero Campillo, Universidad Pontificia Comillas
- Investigators
- Rocío Caballero-Campillo, Dra, Principal investigator, UNINPSI, Universidad Pontificia Comillas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054061
- Sponsor's protocol ID
- 7/22-23
- Other IDs
- CX22-00110
- Acronym
- PA+
- Status last verified
- Jul 2026
- First submitted
- 5 Sep 2023
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Subjective Wellbeing Despite a Severe Psychiatric Condition Through "Think and Cope Positively" Program: A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT06054061
- Acronym / sponsor ID
- PA+ / 7/22-23
- Conditions
- Mental Disorder
- Keywords
- Schizophrenia, Subjective Well-Being, Optimism, Coping, Purpose of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- Universidad Pontificia ComillasUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| TAU + Wellbeing promotion group (Think and Cope Positively) Intervention | Experimental | Behavioral: Experimental: experimental wellbeing promotion group (Think and Cope Positively), Behavioral: TAUIn 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. |
| TAU + waiting list | Other | Behavioral: TAUThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | TAU + Wellbeing promotion group (Think and Cope Positively) Intervention |
| TAUThe 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. | Behavioural | TAU + Wellbeing promotion group (Think and Cope Positively) Intervention, TAU + waiting list |
Primary outcome
Satisfaction with life scale (SWLS)
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.
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)
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.
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.
3 secondary outcomes
Openness to the Future Scale (OFS)
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.
Therapeutic Alliance and Theory of Change Inventory (WATOCI)
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.
Symptom Checklist-45 abbreviated version
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rocío Caballero-Campillo, Dra principal investigator
UNINPSI, Universidad Pontificia Comillas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: experimental wellbeing promotion group (Think and Cope Positively) and TAU in people with Mental Disorder, run by Universidad Pontificia Comillas at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with life scale (SWLS) (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.