(Cost)effectiveness of a cognitive group prevention module for recurrent depression.|
|- candidate number||1760|
|- NTR Number||NTR454|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||12-okt-2005|
|- Secondary IDs||N/A |
|- Public Title||(Cost)effectiveness of a cognitive group prevention module for recurrent depression.|
|- Scientific Title||(Cost)effectiveness of a cognitive group prevention module for recurrent depression.|
|- hypothesis||Our primary hypothesis was that in remitted patients with recurrent depression, augmenting TAU with CT would reduce and/or postpone relapse/recurrence. In view of Teasdaleís (et al., 2000) findings, we expected this effect to be moderated by the number of previously experienced depressed episodes. As secondary hypotheses, we expected that augmenting treatment as usual with CT would also reduce the severity of a depressive episode, and the number of times a patient would have a relapse/recurrence. Finally, an exploratory aim of the study was to analyze differences in demographic, clinical and psychological characteristics between patients below or above the reversal point for number of previous depressive episodes needed for potential benefit from CT.|
|- Healt Condition(s) or Problem(s) studied||Depression|
|- Inclusion criteria||To be eligible, patients had to meet the following criteria: |
1. Experienced at least two Major Depressive Episodes (MDEs) in the previous five years, as defined according to the Diagnostic and Statistical Manual of mental Disorders (DSM-IV: American Psychiatric Association, 1994) and assessed with the Structured Clinical Interview for DSM-IV (SCID; First, Gibbon, Spitzer, & Williams, 1996) administered by trained interviewers;
2. Were currently in remission according to DSM-IV criteria, for longer than ten weeks and no longer than two years (i.e. a high-risk group of relapse/recurrence);
3. Obtained a current score of <10 on the Hamilton Rating Scale for Depression (Hamilton, 1960).
|- Exclusion criteria||Exclusion criteria were current mania or hypomania or a history of bipolar illness, any psychotic disorder (current and previous), organic brain damage, alcohol or drug misuse, predominant anxiety disorder, recent ECT, recent cognitive treatment or receiving CT at the start of the study, or current psychotherapy with a frequency of more than two times a month.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-1999|
|- planned closingdate||31-dec-2005|
|- Target number of participants||187|
|- Interventions||Cognitive therapy (CT). The CT in the experimental condition involved eight weekly two-hour sessions. As in other prevention studies (Ma &Teasdale, 2004; Teasdale et al., 2000) a group format was chosen, for cost-effectiveness reasons but also because we were dealing with a patient group without current psychopathology. |
More specifically, we used a closed format with a mean membership of 8 (7 to12 members). Each CT session followed a fixed structure, with agenda setting, review of homework, explanation of rationale of each session, and assignment of homework. Nine specifically trained psychologists (one of them was the principal investigator) delivered the prevention module; all were fully trained cognitive behavior therapists (minimum of 5 years of training). Before conducting the experimental groups, each therapist received 16 hours of additional specific training. A treatment manual (available on request from first author) was used and regular supervision was provided. All intervention group sessions were audiotaped to enable treatment integrity to be evaluated, using a checklist of all particular interventions. Any adherence or competence issues were resolved with the therapist prior to the subsequent session (in fact only one instance: an overlooked homework assignment).
The CT was focused mainly on identification and change of dysfunctional attitudes. Unlike CT for acutely depressed patients (Beck, 1987; Beck, Rush, Shaw, & Emery, 1979), the present module was not primarily directed toward modifying negative thoughts. Instead, it started with the identification of negative thoughts (Session 1) and dysfunctional attitudes, aided by a self report questionnaire with examples of attitudes and techniques such as vertical arrow technique (Sessions 1-3), and then proceeded to focus on changing of these attitudes using different cognitive techniques such as Socratic questioning and identification of positive attitudes (Sessions 3-7). Moreover, patients were encouraged to practice with alternative attitudes (Sessions 6-8). In contrast with the preventive program of Teasdale and colleagues (2000), involving additional meditation interventions were used, solely cognitive interventions were used in the present study, concentrated on change of content. Several studies have found that in comparison with normal controls acutely depressed patients have a tendency to retrieve more overgeneral autobiographical memories on a cue-word task (i.e., more generic memories of past events rather than specific memories referring to a particular event happening on a particular time and place (i.e., Goddard, Dritschel & Burton, 1996; Williams & Scott, 1988). This inability to retrieve specific memories from the past is associated with impaired problem-solving skills (i.e., Pollock & Williams, 2001), long-term course of depressive disorders (Peeters, Wessel, Merkelbach, & Boon-Vermeeren, 2002) and difficulties in recovering from depression (i.e., Brittlebank, Scott, Williams, & Ferrier, 1993). Unlike with traditional acute CT, patients were asked to keep a diary of positive experiences in order to enhance specific memories of positive experiences, instead of retaining overgeneral memories. (sessions 4-6). Further specific relapse/recurrence prevention strategies were formulated in the last three sessions.
Control group: treatment as usual.
|- Primary outcome||Relapse/recurrence To assess relapse/recurrence, we used the Structured Clinical Interview for DSM-IV (SCID-I; First, Gibbon, Spitzer, & Williams, 1996) was used. At baseline and at three follow-up assessments (3, 12, and 24 months), current and past depressive episodes were checked.|
|- Secondary outcome||The number of relapse/recurrence and severity relapse/recurrence.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| Claudi Bockting|
|- CONTACT for SCIENTIFIC QUERIES|| Claudi Bockting|
|- Sponsor/Initiator ||Academic Medical Center (AMC) / De Meren|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, National Foundation of Mental Health Care (NFGV)|
|- Publications||1. Bockting, CLH, Schene, AH, Spinhoven, Ph, Koeter, MWJ, Wouters, LF, Huyser, J, & Kamphuis, JH: Preventing relapse/recurrence in recurrent depression using cognitive therapy. J Cons Clin Psychology 2005;73: 647-657. |
2. Bockting, CLH, Spinhoven, Ph, Koeter, MWJ, Wouters, LF, Visser, I, Schene, AH & the DELTA study group: Differential predictors of response to preventive cognitive therapy in recurrent depression: a 2-year prospective study, accepted for publication, Psychotherapy and Psychosomatic, july 2005.
3. Bockting, CLH, Spinhoven, Ph, Koeter, MWJ, Wouters, LF, Schene, AH & the DELTA study group: Prediction of recurrence in recurrent depression and the influence of consecutive episodes on vulnerability: a 2-year prospective study, resubmitted Journal of Clinical Psychiatry, october 2005.
4. Bockting, C., Schene, A.H., Huyser, J., Spinhoven, P. en de DELTA-studiegroep (2005). Recidiverende depressie: herstel en terugval in een Nederlands cohort. In: F. Boer, T.J. Heeren, J.P.C. Jaspers, B. Sabbe & J. van Weeghel (eds.). Jaarboek voor psychiatrie en psychotherapie 2005-2006. Houten: Bohn, Stafleu en Van Loghum, pp. 99-115.
5. Huyser, J., Schene, A.H., Bockting, C., (2001). Recidiverende depressieve stoornissen: beloop en predictoren. In: Schene, A.H., F. Boer, T.J. Heeren, J.P.C. Henselmans, H.W.J., Trijsburg, R.W., Vandereycken, W., van der velden, K. (eds.). Jaarboek voor psychiatrie en psychotherapie 2001-2002. Houten: Bohn, Stafleu en Van Loghum, pp. 21-40.
6. Bockting, C.l.H. Cognitieve therapie bĳ depressie, (2003). Uitgever : Amsterdam : Psychiatrie AMC/De Meren.
7. Huyser, J., Schene, A.H., Bockting, C., (2003) BehandelingstrategieŽn bij chronische depressie en dysthymie. In: Dagbehandeling en klinische opname bij chronische depressie. Bohn Stafleu Van Loghum, Houten/Diegem 2003, p. 101-112.
8. Bockting, C.l.H, Schene, A.H., Spinhoven, Ph., e.a.
J of Consulting and Clinical Psychology, 2005;73: 647-657.
|- Brief summary||This article reports on the outcome of a randomized controlled trial of cognitive group therapy (CT) to prevent relapse/recurrence in a group of high-risk patients diagnosed with recurrent depression. Recurrently depressed patients (N=187) currently in remission following various types of treatment were randomized to treatment as usual, including continuation of pharmacotherapy, or to treatment as usual augmented with brief CT. Relapse/recurrence to major depression was assessed over two years.
Augmenting TAU with CT resulted in a significant protective effect, which
intensified with the number of previous depressive episodes experienced. For patients with five or more previous episodes (41% of the sample), CT reduced relapse/recurrence from 72% to 46%.
Our findings extend the accumulating evidence that cognitive interventions following remission can be useful in preventing relapse/recurrence, in patients with recurrent depression. Currently 5,5 year follow-up data are collected.
|- Main changes (audit trail)|
|- RECORD||12-okt-2005 - 9-okt-2008|
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