Depressive Disorder Clinical Trial
Official title:
Telephone-administered Cognitive-behavioral Relapse Prevention for Patients With Chronic and Recurrent Depression: A Multi-center Randomized Clinical Trial
This study determines the effectiveness of telephone-delivered cognitive-behavioral continuation therapy (T-CT) in comparison to usual care in people with recurrent or chronic depression. The primary research question is whether participating in T-CT reduces depressive relapses. The continuation therapy comprises eight therapy sessions delivered over the telephone by a trained therapist over a period of approximately six months following acute-phase psychotherapy.
Major depression is a serious mental disorder that often takes a recurrent or chronic course causing enduring individual suffering as well as immense direct and indirect health costs. Research indicates that psychological continuation interventions following successful acute-phase therapy are effective in preventing depressive relapse and recurrence but access to these interventions is limited. Systematic psychological continuation interventions are hardly implemented in health care yet, and research shows that there are obstacles concerning access to and compliance for these interventions in a face-to-face setting underlining the need for alternative ways of delivery. The present study ("NaTel study") aims to investigate the effectiveness of telephone-administered cognitive-behavioral continuation therapy (T-CT) following acute-phase psychotherapy. The primary research question is whether participating in T-CT reduces depressive relapses within an observation period of 18 months compared with usual care alone. T-CT comprises eight therapy sessions delivered over the telephone by a trained therapist over a period of approximately six months after acute-phase therapy. Focus of the structured intervention is to train and foster relapse prevention strategies and to facilitate the transfer of skills acquired during acute-phase therapy to daily life. The effectiveness of T-CT as add-on to usual care is tested in a two-parallel group, multicenter, evaluator-blind clinical trial in patients with chronic/persistent or recurrent depressive disorder. Upon acute-phase therapy termination patients who have responded to cognitive behavioral therapy are randomized either to T-CT or usual care alone. Primary outcome of this study is relapse of a depressive episode. Relapse is determined by investigators blind to the study conditions based on clinical interviews conducted at months 6, 12, and 18 of follow-up. Further secondary outcome criteria are assessed with interviews and self-report questionnaires at various time points during follow-up. Overall, the study lasts approximately 48 months. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01316926 -
Paxil CR Bioequivalence Study Brazil
|
Phase 1 | |
Recruiting |
NCT06187454 -
Transcranial Direct Current Stimulation for Depression
|
N/A | |
Completed |
NCT04469322 -
Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression
|
N/A | |
Recruiting |
NCT05768126 -
Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine
|
Phase 4 | |
Recruiting |
NCT06038721 -
Unified Protocol: Community Connections
|
N/A | |
Completed |
NCT03043560 -
Study to Treat Major Depressive Disorder With a New Medication
|
Phase 2 | |
Completed |
NCT04091139 -
Research of Unified Protocol for the Treatment of Common Mental Disorders in Adolescents in Hong Kong
|
Phase 2/Phase 3 | |
Completed |
NCT00069459 -
Seasonal Affective Depression (SAD) Study
|
Phase 1 | |
Recruiting |
NCT05503966 -
Combining Antidepressants and Attention Bias Modification in Depression
|
N/A | |
Recruiting |
NCT03001245 -
Interpersonal Counseling (IPC) for Treatment of Depression in Adolescents
|
N/A | |
Completed |
NCT02939560 -
TMS for Adults With Autism and Depression
|
N/A | |
Completed |
NCT02542891 -
European Comparative Effectiveness Research on Internet-based Depression Treatment
|
N/A | |
Completed |
NCT02452892 -
Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)
|
N/A | |
Completed |
NCT02306551 -
Well Being And Resilience: Mechanisms of Transmission of Health and Risk
|
||
Withdrawn |
NCT02238730 -
Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy
|
N/A | |
Completed |
NCT02224508 -
Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks
|
N/A | |
Completed |
NCT01597661 -
Bupropion & Cardio Birth Defect (Slone)
|
N/A | |
Completed |
NCT01407575 -
Buprenorphine for Treatment Resistant Depression
|
Phase 3 | |
Completed |
NCT01093053 -
Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations
|
N/A | |
Completed |
NCT01829100 -
Transdiagnostic Behavioral Activation Therapy for Youth Anxiety and Depression
|
N/A |