(Cost)effectiveness of a cognitive group prevention module for recurrent depression

ISRCTN	ISRCTN68246470
DOI	https://doi.org/10.1186/ISRCTN68246470
Secondary identifying numbers	N/A

Submission date: 27/01/2006
Registration date: 27/01/2006
Last edited: 05/11/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Claudi Bockting
Scientific

Academic Medical Center
De Meren
Tafelbergweg 25 P2-221
Amsterdam
1105 BC
Netherlands

Email	c.l.bockting@amc.uva.nl

Study information

Study design	Multicentre randomised single-blind active-controlled parallel-group trial
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	(Cost)effectiveness of a cognitive group prevention module for recurrent depression
Study hypothesis	Our primary hypothesis was that in remitted patients with recurrent depression, augmenting treatment as usual (TAU) with cognitive therapy (CT) would reduce and/or postpone relapse/recurrence. In view of Teasdale's findings (et al., 2000), 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.
Ethics approval(s)	Received from local medical ethics committee
Condition	Depression
Intervention	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 to 12 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 [Goddard, Dritschel & Burton, 1996; Williams & Scott, 1988]). This inability to retrieve specific memories from the past is associated with impaired problem-solving skills (Pollock & Williams, 2001), long-term course of depressive disorders (Peeters, Wessel, Merkelbach, & Boon-Vermeeren, 2002) and difficulties in recovering from depression (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
Intervention type	Other
Primary outcome measure	Relapse/recurrence: To assess relapse/recurrence, we used the Structured Clinical Interview for DSM-IV (SCID-I; First, Gibbon, Spitzer, & Williams, 1996). At baseline and at three follow-up assessments (3, 12, and 24 months), current and past depressive episodes were checked.
Secondary outcome measures	The number of relapse/recurrence and severity of relapse/recurrence
Overall study start date	01/09/1999
Overall study end date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	187
Participant inclusion 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, fourth edition (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)
Participant exclusion criteria	1. Current mania or hypomania or a history of bipolar illness 2. Any psychotic disorder (current and previous) 3. Organic brain damage 4. Alcohol or drug misuse 5. Predominant anxiety disorder 6. Recent ECT 7. 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
Recruitment start date	01/09/1999
Recruitment end date	31/12/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center

Amsterdam
1105 BC
Netherlands

Sponsor information

Academic Medical Centre (Netherlands)
Hospital/treatment centre

De Meren
Tafelbergweg 25
Amsterdam
1105 BC
Netherlands

"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Research organisation

National Foundation of Mental Health Care (Nationaal Fonds Geestelijke Volksgezondheid [NFGV]) (Netherlands)

No information available

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Private sector organisation / Other non-profit organizations

Alternative name(s): Netherlands Organisation for Health Research and Development
Location: Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/08/2005	Yes	No
Results article	results	01/08/2010	Yes	No
Results article	results	01/08/2012	Yes	No
Results article	results	01/06/2013	Yes	No
Results article	results	01/09/2015	Yes	No
Results article	results	01/10/2015	Yes	No