Condition category
Mental and Behavioural Disorders
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
05/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Claudi Bockting

ORCID ID

Contact details

Academic Medical Center
De Meren
Tafelbergweg 25 P2-221
Amsterdam
1105 BC
Netherlands
-
c.l.bockting@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

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

Received from local medical ethics committee

Study design

Multicentre randomised single-blind active-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/09/1999

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

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 type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

187

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

Trial participating centre

Academic Medical Center
Amsterdam
1105 BC
Netherlands

Sponsor information

Organisation

Academic Medical Centre (Netherlands)

Sponsor details

De Meren
Tafelbergweg 25
Amsterdam
1105 BC
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 results in: http://www.ncbi.nlm.nih.gov/pubmed/16173852
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20797379
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23056456
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23477478
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26036454
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26528654

Publication citations

  1. Results

    Bockting CL, Schene AH, Spinhoven P, Koeter MW, Wouters LF, Huyser J, Kamphuis JH, Preventing relapse/recurrence in recurrent depression with cognitive therapy: a randomized controlled trial., J Consult Clin Psychol, 2005, 73, 4, 647-657, doi: 10.1037/0022-006X.73.4.647.

  2. Results

    ten Doesschate MC, Bockting CL, Koeter MW, Schene AH, , Prediction of recurrence in recurrent depression: a 5.5-year prospective study., J Clin Psychiatry, 2010, 71, 8, 984-991, doi: 10.4088/JCP.08m04858blu.

  3. Results

    van Rijsbergen GD, Bockting CL, Berking M, Koeter MW, Schene AH, Can a one-item mood scale do the trick? Predicting relapse over 5.5-years in recurrent depression., PLoS ONE, 2012, 7, 10, e46796, doi: 10.1371/journal.pone.0046796.

  4. Results

    van Rijsbergen GD, Bockting CL, Burger H, Spinhoven P, Koeter MW, Ruhé HG, Hollon SD, Schene AH, Mood reactivity rather than cognitive reactivity is predictive of depressive relapse: a randomized study with 5.5-year follow-up., J Consult Clin Psychol, 2013, 81, 3, 508-517, doi: 10.1037/a0032223.

  5. Results

    Mocking RJ, Pellikaan CM, Lok A, Assies J, Ruhé HG, Koeter MW, Visser I, Bockting CL, Olff M, Schene AH, DHEAS and cortisol/DHEAS-ratio in recurrent depression: State, or trait predicting 10-year recurrence?, Psychoneuroendocrinology, 2015, 59, 91-101, doi: 10.1016/j.psyneuen.2015.05.006.

  6. Results

    Figueroa CA, Ruhé HG, Koeter MW, Spinhoven P, Van der Does W, Bockting CL, Schene AH, Cognitive reactivity versus dysfunctional cognitions and the prediction of relapse in recurrent major depressive disorder, J Clin Psychiatry, 2015 , 76, 10, e1306-e1312, doi: 10.4088/JCP.14m09268.

Additional files

Editorial Notes