Title of the project: Effect of family focused therapy among caregivers on prognosis of Bipolar Affective Disorder relapsed cases attending psychiatry department of tertiary care hospital, West Bengal.
Background Bipolar Affective Disorder is a chronic disabling disease characterized by severe depression to extreme mania with intervening periods of normalcy . Based on the results of different studies BPAD stands at the 6th, or 7th, place among other debilitating disorders worldwide . Indian scenario 0.3-0.5percent impacting millions. Risk of relapse is 60%in 2year s and73% at 5 yrs, and 2/3 rd of the patients has multiple relapses . A large treatment Gap is there (over 70percent). chronic and recurrent nature of of bipolar disorder impacts several aspects of patients lives, from their interpersonal relationships to the quality of their work. Family focused treatment is a semi-structured treatment that provides psycho education about the nature of mood episodes, individual and family Coping strategies to manage mood swings, and training for the Patient and family members in communication and problem Solving skills for management of Bipolar Disorder. Poor outcome of this illness and their recurrent nature have put bipolar mood disorder among the most debilitating disorder, and has lead researchers to pay more attention to its nonpharmacological treatment. Brief review of literature Among the major mental disorder BPAD one of them. Relapse rate is very high in this disorder. Incidence range from 0.6% -25.0 %5 over the course of lifetime .Life time risk for BPAD ranges from0.6% to 2% in both men and women. Life time risk for major depression ranges from 2% to 25 %. Most authorities agree that an accurate figure is in the range of 10% -15%. It is about 10 % in men and 20 % in women5 Risk of relapse is 73 % at five yrs. 2/3 rd of the case have multiple relapse. Treatment gap for severe mental disorder is 73.6%. In BPAD it is 70.4 %3.Very few study I could found in our Indian set up. So I have select the study to find the effect of family psycho education on prognosis of BPADII relapse pts Current status of the research and development in the subject: Review of literature: A randomized study of family focused psycho education and pharmacotherapy in the outpatient management of bipolar disorder, by Milklowitz DJ, et aI. Arch Gen Psychiatry.2003. It was a randomized control trial. 101 bipolar patients were assigned to fft and pharmacotherapy or a less intensive crisis management (CM) intervention and pharmacotherapy. Outcome assessment were conducted every 3-6 month for 2 yrs.21 session FFT were given . Psycho education, communication training , problem solving, skill raining were included in FFT. The study result showed that Patients undergoing fewer relapses (11/31, 35%), and longer survival intervals.(mean+/-sd, 73.5+/-28.8 wks.) Patients undergoing FFT showed greater reduction in mood disorder symptoms and better medication adherence during the 2 yrs than pts undergoing CM.4 Milklowitz DJ, et aI. J Clin Psychiatry.2003, Integrated family and Inidividual therapy for bipolar disorder: Results of a treatment development study: This study was done on a new psycho social approach- Integrated family and Individual approach (IFIT) that synthesizes family psycho educational sessions with individual sessions of interpersonal and social rhythm therapy. 30 BPAD pts were included in this study. 50 weekly sessions of family and individual therapy) and mood stabilizing medications in the context of a treatment development study. Their outcome of I year were compared with the outcome of 70 pts from a previous trial who receives standard community care, consisting of 2 family educational sessions, mood stabilizing medication and crisis management(CM). Study results shows -combining family and individual therapy with medication may protect episodic bipolar pts from early relapse and ongoing mood symptoms6. Andrea Fiorillo, Phd of the university of Naples, Itally and colleagues examined the efficacy of a type of psycho education, Known as Faloon Intervention, added on to treatment as usual( Tau) in BPAD I patients. A total 137 patients with BPAD I were randomized to receive either TAU or TAU with psycho education. The psycho education which took place between 12 &18, 90 minutes session, focused on teaching family members about the disorder. Treatment, warning signs, managing suicidal behavior and problem solving skills. Patients whose families took part in the psycho education showed significant improvement in social functioning compared to no statistically significant change in social functioning in those patients in the TAU only group. Abigail K. Mansfield, Jenifer A. Delay & Gabor.2011, Keithner was conducted : A review literature-A meta analysis on Family Interventions for Bipolar disorder:, review of Pubmed data base performed on 1964-1 st sept 2011- 953 citation revealed ten unique randomized control trial of family based interventions for BPAD. Approaches of intervention varied but results indicated that family based psycho education is effective in reducing relapse of manic symptoms, while family based psycho therapeutic interventions are more effective in reducing relapse of depressive symptoms. Significance of the present research: There has been significant improvement in available treatment for bipolar mood disorder during the past few year, however, this disorder still causes difficulties for the patients, their families, and the society(kleinmen et al 2003)Overall studies have demonstrated that this disease affects patients entire family and may weaken its strength and adaptive abilities(Barry,2001). Poor outcome of this illness and their recurrent nature have put bipolar mood disorder among the most debilitating disorder, and has lead researchers to pay more attention to its treatment(miklowitz et al,2004).Based on the results of different studies, this disorder stands at the 6th, or 7th, place among other debilitating disorders worldwide(Calabrese,etal 2003,Chisholm et al 2005,simon et al, 2006).chronic and recurrent nature of of bipolar disorder impacts several aspects of patients lives, from their interpersonal relationships to the quality of their work. As an example divorce rate is reported to be higher in this patient population(Ghoreishadeh et al,2008). Pharmacological treatment alone has not been successful for complete improvement(Bassili,2009).compliance is an issue in the treatment of BMD, this disorder itself in some cases disrupting patients judgment. Furthermore quality of life is impaired even during remission, and the suicide rate is reported to be as high as 20%-30%(Bellivier et al,2005). Problems which are usually unnoticed that is – • Inter episodic period quality of life of BPAD patients are deteriorate. e g patients suffers from decreased self esteem, strange IPR with spouse and other person. Addiction, risk taking behavior specially risky investment, chronic low grade severity of the disease i.e dysthymia, GAD, social phobia, chronic low grade depression etc. • Apart from these high suicide rates, attempt/thought during acute episode and in other times, frequent relapse, incomplete remission, and recurrence. • Decreased productivity in life, workplace as well as in family due to tendency of argumentativeness with authority, family members, irregularity at job in family functioning fluctuating relationships with friends, decreased confidence or pseudo overconfidence in various matters. • Central theme is decreased self esteem. • These all we see in patients but psychiatrist does not give too much attention due to deficit of awareness about the facts, lack of appropriate, adequate staff, and lack of appropriate awareness. • Most of the psychiatrists opinion is BPAD is a biological disorder but literature says actually it is a bio psycho social disorder not only biological disorder. Operational definitions: Family Focused Therapy: (FFT) includes both the person with bipolar disorder and their parents, spouse, or with their other family members. FFT depends on the family needs. The sessions focuses on Psycho education, communication enhancement training and problem solving skill training .Therapy will be given in indoor and OPD set up. FFT will be developed and validated. The techniques will be Joining and Assessment > Restructuring > value changes > generalization. Prognosis: The likely outcome or course of disease, the chance of recovery or recurrence. In the present study prognosis means the outcome of family focused therapy in terms of recurrence, re hospitalization, no of relapse, treatment adherence, Quality of life, and clinical outcome of BPAD II. Relapse: Worsening or re occurrence of depressive ,manic or hypomanic affective signs and symptoms after a period of eight weeks of a pre morbid level of functioning. Remission: Absence or minimal symptoms of both hypomania and depression for at least 1 week sustained remission requires at least 8 consecutive weeks or remission and perhaps as many as 12 weeks. Re –occurrence: Another episode of depression or hypomania or mania after complete cure or touching the baseline. Primary objective: 1)To prepare the Family focused therapy protocol and validate it. 2)To provide FFT to the caregivers and patients of BPADII relapsed cases. 3)To find out the effect of FFT on the prognosis of BPAD relapsed patients in terms of the disease outcome , Relapse rate, quality of life , treatment adherence , caregivers expressed emotion. 4)To find out the association between prognosis and sociodemographic profile od BPAD patients. Secondary objectives: 1. To find the feasibility of family focused therapy in clinical setting. Hypothesis: 1. H0: There is no significant difference in prognosis between experimental and control group BPAD relapse patients at 0.05 level of significance. 2. H1: There is significant difference in prognosis between experimental and control group BPAD relapse patients at 0.05 level of significance. Research Methodology: · Research Approach : quantitative Research Approach. Interventional study. · Research design :. Randomized parallel group design · Setting: psychiatry department (Indoor and OPD) of MCH, Kolkata. · Population: caregivers and the patients of Bipolar Affective disorder. · Sample: exp group= 90 and control group=90 · Sampling: Non probability sampling · Method for Generating Randomization Sequence: Computer generated randomization · Method for Allocation of Concealment: Sequentially numbered, sealed, opaque envelopes · Blinding/Masking: Participant and Outcome Assessor Blinded · Variables :I V Independent variable: FFT(Family Focused Therapy) , Dependent variable: prognosis of disease (re hospitalization, number of relapse, treatment adherence, quality of life.) · Data collection tool: Family Focused Therapy protocol is prepared and validated properly. · Standardized Assessment tools: of HDRS-Hamilton Depression Rating Scale, YMRS (Young Mania Rating scale), WHOQOL BRIEF, MARS(Medication Adherence rating scale) FAS(Family attitude scale). Family focused therapy: (FFT) includes both the person with bipolar disorder and their parents, spouce, or with their other family members. FFT typically depends on the family needs given by single therapiest .The sessions focuses on education about the condition,: its symptoms and how they cycle over time, its causes, how to recognize the early warning signs of new episodes, and what to do as a family to prevent the episodes from getting worse, communication skill training and problem solving skill training specially to address family conflicts. FFT starts with a deep appreciation of the ways that patient’s family system and the complecated web of relationships found therein may supports patients conditions, or alternatively, exacerbate them. Therapiest work to identify difficulties and conflicts with in the family that may contribute to patient and family stress, and then helped the involved family members to finds ways to resolve those difficulties and conflicts. The term ‘Expressed Emotion refers to critical, hostile and over involved attitudes and behaviours that family members may have towards and act out with other family members who have psychiatric disorders. Therapiest work to to help family members to become aware of and bring under control any expressed emotion they be acting out. For example, the parents of an adolescent’s daughter with bipolar disorder may be quite upset by their Childs illness, and as a result, motivated to act in an overcontrolling manner that the child rebels against. The daughter’s rebelion adds significant stress to her already complicated condition. Recognizing this dynamic, therapiest might advise the parents to find less controlling ways to express their caring and concern, and help them to manage their own stress in a manner more independent from their daughter than they were able to manage previously. Joining & Assessment: Gain family trust and indentify strength & areas of family need Restructuring Identify maladaptive patterns and practice new skills Valuing changes See change as necessary over compliance Generalization Skill adoption and predict future challenges Ethical Consideration : Institutional Ethical committee clearance: Ethical permission is taken from the Scientific Advisory Committee and the Ethical Committee, Medical College Hospital .Kolkata Informed consent: has to be taken from the caregivers, and the patients of bipolar affective disorder. Data analysis: Effectiveness of FFT (family focused therapy) between experimental and control group will be analyzed by unpaired ‘t’ test, chi square test to find out the association and for co-relation, regression analysis will be done. Conclusion: BPAD is a common major mental disorders and are chronic in nature. Pts complete clinical and functional recovery depends on caregivers attitude as well as family environment. Intensive supervision and guidance by Family psycho education therapy can improve the outcome of this disorder. i.e. relapse rate will reduce, and treatment gap will reduce. The study outcome will create awareness and willingness of the medical professionals to introduce psychosocial therapy in treatment of bipolar disorder.
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