Psychological Support Group and Its Effects on Mood, Anxiety and Coping

NCT06264050 | Active Not Recruiting

• 1 other identifier: 2023.04
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to verify the influence that participation in a Psychological Support Group has on anxiety, depression and coping skills in patients admitted to the IRCCS San Camillo Hospital. It is therefore an observational study with a pre-post design on a cohort of patients hospitalized at San Camillo IRCCS who attend the Psychological Support Group. The study consists of verifying whether the therapeutic activity of the Psychological Support Group (GSP) has an influence on the levels of anxiety, mood and coping skills in the patients who attend it. These purposes will be pursued through the administration to each patient at the beginning (pre) and at the end (post) of the period of attendance at the GSP, of validated scales: Stay Y2 (anxiety), BDI II(depressive symptoms), COPE NVD 25 (coping strategies) and the CORE-OM (outcomes of psychological activity).

Conditions

Coping Strategies; Anxiety; Nurse-Patient Relations; Psychological; Mood Depressed; Rehabilitation; Neurologic Manifestations

Outcome Measures

Primary Outcomes (4)

• The State-Trait Anxiety Inventory (STAI) Y2

  The Stai Y2 instead measures state anxiety (State-anxiety), i.e. a transitory emotional state of an individual in a particular situation, unlike trait anxiety (Trait-anxiety) which reflects a personality variable that stably characterizes the individual and differentiates him from others in the propensity to respond with high levels of anxiety to situations perceived as dangerous. Trait anxiety is measured by the Stai version Y1

  10 minutes

• The Beck Depression Inventory II (BDI-II)

  The Beck Depression Inventory II (BDI-II) has 21 items on a 4-point Likert scale (from 0 to 3) and a total score ranging from 0 to 63. Given that the BDI does not diagnose depression but the presence of depressive symptoms, according the manual scores from 0 to 13 indicate normality, from 14 to 19 mild depression, from 20 to 28 moderate depression, from 29 to 63 severe depression.

  15 minutes

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

  The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a 34-item self-report instrument for measuring outcomes in psychological treatments that has been shown to be reliable, valid, and acceptable in various clinical settings. The items cover four domains: subjective well-being, problems/symptoms, life functioning, and risk. Higher scores in all domains indicate greater psychological problems

  20 minutes

• The Coping Orientations to Problem Experienced NVI - 25

  The Coping Orientations to Problem Experienced is a self-report questionnaire that takes into consideration different coping methods. The questionnaire asks you to evaluate how often the subject implements that particular coping process in difficult or stressful situations; There are four answer possibilities, from "I usually don't do it" to "I almost always do it". The short version validated in Italian (NVI) has 25 items instead of the 60 of the original version. All elements were grouped into 5 subdimensions, namely: Avoidance strategies, Transcendental orientation, Positive attitude, Social support, Problem orientation.

  15 minutes

Study Arms (1)

Patients in the psychological support group

OTHER

Patients in neurorehabilitation attending a psychological support group

Diagnostic Test: evalutaion scales

Interventions

evalutaion scales DIAGNOSTIC_TEST

four scales will be administered to whom attend a psychological support group: BDI II (depression); Stai Y2 (trait anxiety); Cope NVI 25 (coping strategies) and Core OM (psychological state)

Patients in the psychological support group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients hospitalized at the IRCCS San Camillo. Patients with indication to attend the Psychological Support Group. Patients who have given valid consent. Patients able to understand and read Italian. Patients with any type of neurological pathology for which they are admitted to neurorehabilitation.
• Aphasic patients without comprehension deficits and able to communicate effectively with augmented communication media.

You may not qualify if:

• Patients unable to give valid consent. Minor patients or patients over 85 years of age. Patients with participation in the Psychological Support Group of less than three sessions.
• Patients with cognitive deficits that prevent them from completing the scales and taking the interview.
• Patients unable to understand and read Italian. Patients with pathologies for which they are not undergoing neurorehabilitation treatment.

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Related Publications (16)

• Castelnuovo G, Giusti EM, Manzoni GM, Saviola D, Gatti A, Gabrielli S, Lacerenza M, Pietrabissa G, Cattivelli R, Spatola CA, Corti S, Novelli M, Villa V, Cottini A, Lai C, Pagnini F, Castelli L, Tavola M, Torta R, Arreghini M, Zanini L, Brunani A, Capodaglio P, D'Aniello GE, Scarpina F, Brioschi A, Priano L, Mauro A, Riva G, Repetto C, Regalia C, Molinari E, Notaro P, Paolucci S, Sandrini G, Simpson SG, Wiederhold B, Tamburin S. Psychological Treatments and Psychotherapies in the Neurorehabilitation of Pain: Evidences and Recommendations from the Italian Consensus Conference on Pain in Neurorehabilitation. Front Psychol. 2016 Feb 19;7:115. doi: 10.3389/fpsyg.2016.00115. eCollection 2016.

  PMID: 26924998 RESULT

• Chiu EC, Chen YJ, Wu WC, Chou CX, Yu MY. Psychometric Comparisons of Three Depression Measures for Patients With Stroke. Am J Occup Ther. 2022 Jul 1;76(4):7604205140. doi: 10.5014/ajot.2022.049347.

  PMID: 35727642 RESULT

• Denham AMJ, Baker AL, Spratt N, Guillaumier A, Wynne O, Turner A, Magin P, Bonevski B. The unmet needs of informal carers of stroke survivors: a protocol for a systematic review of quantitative and qualitative studies. BMJ Open. 2018 Jan 31;8(1):e019571. doi: 10.1136/bmjopen-2017-019571.

  PMID: 29391371 RESULT

• Gregorio GW, Brands I, Stapert S, Verhey FR, van Heugten CM. Assessments of coping after acquired brain injury: a systematic review of instrument conceptualization, feasibility, and psychometric properties. J Head Trauma Rehabil. 2014 May-Jun;29(3):E30-42. doi: 10.1097/HTR.0b013e31828f93db.

  PMID: 23640542 RESULT

• Huang SL, Hsieh CL, Wu RM, Lu WS. Test-retest reliability and minimal detectable change of the Beck Depression Inventory and the Taiwan Geriatric Depression Scale in patients with Parkinson's disease. PLoS One. 2017 Sep 25;12(9):e0184823. doi: 10.1371/journal.pone.0184823. eCollection 2017.

  PMID: 28945776 RESULT

• Kampling H, Reese C, Kust J, Mittag O. Systematic development of practice guidelines for psychological interventions in stroke rehabilitation. Disabil Rehabil. 2020 Jun;42(11):1616-1622. doi: 10.1080/09638288.2018.1530308. Epub 2019 Jan 7.

  PMID: 30616425 RESULT

• Liao B, Liang M, Ouyang Q, Song H, Chen X, Su Y. Psychological Nursing of Patients With Stroke in China: A Systematic Review and Meta-Analysis. Front Psychiatry. 2020 Dec 11;11:569426. doi: 10.3389/fpsyt.2020.569426. eCollection 2020.

  PMID: 33362596 RESULT

• Palmieri G, Evans C, Hansen V, Brancaleoni G, Ferrari S, Porcelli P, Reitano F, Rigatelli M. Validation of the Italian version of the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM). Clin Psychol Psychother. 2009 Sep-Oct;16(5):444-9. doi: 10.1002/cpp.646.

  PMID: 19701881 RESULT

• Pearce G, Pinnock H, Epiphaniou E, Parke HL, Heavey E, Griffiths CJ, Greenhalgh T, Sheikh A, Taylor SJ. Experiences of Self-Management Support Following a Stroke: A Meta-Review of Qualitative Systematic Reviews. PLoS One. 2015 Dec 14;10(12):e0141803. doi: 10.1371/journal.pone.0141803. eCollection 2015.

  PMID: 26657458 RESULT

• Raciti L, Corallo F, Manuli A, Calabro RS. Nursing, Caregiving and Psychological support in Chronic Disorders of Consciousness: a scoping review. Acta Biomed. 2021 Mar 31;92(S2):e2021013. doi: 10.23750/abm.v92iS2.11329.

  PMID: 33855992 RESULT

• Santangelo G, Sacco R, Siciliano M, Bisecco A, Muzzo G, Docimo R, De Stefano M, Bonavita S, Lavorgna L, Tedeschi G, Trojano L, Gallo A. Anxiety in Multiple Sclerosis: psychometric properties of the State-Trait Anxiety Inventory. Acta Neurol Scand. 2016 Dec;134(6):458-466. doi: 10.1111/ane.12564. Epub 2016 Feb 1.

  PMID: 27219913 RESULT

• Sarkamo T. Cognitive, emotional, and neural benefits of musical leisure activities in aging and neurological rehabilitation: A critical review. Ann Phys Rehabil Med. 2018 Nov;61(6):414-418. doi: 10.1016/j.rehab.2017.03.006. Epub 2017 Apr 29.

  PMID: 28461128 RESULT

• Sihvonen AJ, Sarkamo T, Leo V, Tervaniemi M, Altenmuller E, Soinila S. Music-based interventions in neurological rehabilitation. Lancet Neurol. 2017 Aug;16(8):648-660. doi: 10.1016/S1474-4422(17)30168-0. Epub 2017 Jun 26.

  PMID: 28663005 RESULT

• Soratto J, Pires DEP, Friese S. Thematic content analysis using ATLAS.ti software: Potentialities for researchs in health. Rev Bras Enferm. 2020 Apr 22;73(3):e20190250. doi: 10.1590/0034-7167-2019-0250. eCollection 2020.

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• Starkstein SE, Lischinsky A. The phenomenology of depression after brain injury. NeuroRehabilitation. 2002;17(2):105-13.

  PMID: 12082237 RESULT

• Wang YP, Gorenstein C. Assessment of depression in medical patients: a systematic review of the utility of the Beck Depression Inventory-II. Clinics (Sao Paulo). 2013 Sep;68(9):1274-87. doi: 10.6061/clinics/2013(09)15.

  PMID: 24141845 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Consciousness Disorders; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Mental Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders

Study Officials

• Alberto Camuccio, doctor

  IRCCS San Camillo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pre post study on a single cohort

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 16, 2024
• Study Start: January 8, 2004
• Primary Completion: September 8, 2024
• Study Completion: March 15, 2025
• Last Updated: February 16, 2024

Record last verified: 2024-02