Dialogical and Narrative Processes in Couple Therapy for Depression (DINADEP)
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | April 16, 2009 | ||||
| Last Updated Date | April 16, 2009 | ||||
| Start Date ICMJE | February 2006 | ||||
| Primary Completion Date | July 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Hamilton Depression Rating Scale; BDI and SCL-90 Dyadic Adjustment Scale (DAS)for couples -domestic violence, use of alcohol [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Outcome Ratings Scale and Session Rating Scale video recordings co-research interviews [ Time Frame: 3 months after termination ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Dialogical and Narrative Processes in Couple Therapy for Depression | ||||
| Official Title ICMJE | Dialogical and Narrative Processes in Couple Therapy for Depression. Two Year Follow-up Study of the Effectiveness and Processes in Couple Therapy | ||||
| Brief Summary | The main aim of the project is to develop couple therapy for depression with special interest in dialogical and narrative processes in therapy. Parenthood, and different psychosocial phenomena, such as domestic violence, suicidal behaviour and alcohol abuse in relation to the client's specific depressive state will be analysed. The second main aim of the study is to analyse the effectiveness couple therapy for depression as a real world study. The good and poor outcome of different therapy processes will be compared and thus information about precise change processes will be reached. Owing to the real world setting, the inclusion criterion is a broad one: a primary diagnosis of depression (F32 and F33 in ICD-10). The project will be conducted as a multicentre study so that in each centre the included patients will be randomized into experiment and control groups. The study centres are (1) Pohjois-Savon sairaanhoitopiiri in Kuopio, (2) Länsi-Pohjan sairaanhoitopiiri in Tornio and Kemi and (3) HUS/ Jorvin sairaala regional psychiatric polyclinics in Espoo. In each province the entire adult population has free access to the psychiatric outpatient clinics in their specific catchment area and thus no selection for the patients is done. |
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| Detailed Description | In each of these research centres qualified family therapists will conduct the couple therapy in case of depressed patients in a team of two therapists. To be a responsible therapist in this study the minimum criterion is three years specialist- level family therapy training and thus a qualification as psychotherapist according to Finnish law. The therapist shall have special experience and interest in dialogical and narrative processes in therapy. All the family therapists will also have taken a training program that focuses on systemic family therapy, narrative therapies and open dialogue in a family setting. No special therapy manual has been written, but the treatment processes will be analyzed after the therapy in relation to the outcome. The treatment processes are expected to last for as long as required according to the specific needs of each couple. This will allow for the focus on external validity: Clients will be recruited in the course of daily clinical practice without any selection outside the diagnosis and the therapies are taking place for as long as needed. The analyses of the treatment processes in relation to outcome, has termed as progress research by Pinsof & Wynne (2000) In couple therapy some guidelines are followed. Since every family therapist has training in systemic therapy, the therapy can be termed as systemic couple therapy with a special focus on dialogues and narratives. The two therapists and the couple form a system in which the first aim is to generate dialogue to increase understanding of couple's situation and the role of depression in their lives. To this end, spouses are encouraged to speak of subjects that they find most important. While one person is speaking, the other three take a reflective position in their inner dialogues and afterwards describe their thoughts about what was said. The shift between the speaking and listening positions in the topics that the couple choose is the basic element in each therapy process. In these processes a new joint language is created for experiences without words or experiences manifested in symptoms, marital problems or in problematic behaviour. Three types of analysis will be conducted:
Control group is formed in each of the three centres. These clients will not have family therapy sessions during the first 12 months; instead, according to the manner usual in each centre they will visit a psychiatrist or other therapists. Clients will be randomly assigned to the experimental and control groups after the doctor admitting them has assessed their inclusion by diagnosis and the Hamilton Rating Scale and after the first research interview has been conducted. The inclusion period started in February 2006 and lasted until summer 2007. The first follow-up interviews will continue until the end of 2009. In this specific project the analysis of the data will begin in 2007 and continue to the end of 2010 concerning this specific project. Thereafter the data will be available for post graduate and doctoral students under the supervision of the principal investigators. Department of Psychology at the University of Jyväskylä is the study site, in which all the data will be gathered. In each centre the research data will be stored outside of patient records. Information of the ratings scales can be added to specific patient records. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Depression | ||||
| Intervention ICMJE | Behavioral: Psychotherapy
Narrative and dialogical approach for couples |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 65 | ||||
| Estimated Completion Date | October 2009 | ||||
| Primary Completion Date | July 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 15 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Finland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00883207 | ||||
| Other Study ID Numbers ICMJE | DINADEP | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jaakko Seikkula/Professor, Department of Psychology, UNiversity of Jyvaskyla | ||||
| Study Sponsor ICMJE | University of Jyvaskyla | ||||
| Collaborators ICMJE | University of Eastern Finland | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | University of Jyvaskyla | ||||
| Verification Date | April 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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