Trial Outcomes & Findings for Mindfulness Based Cognitive Therapy for Recurrent Depression (NCT NCT01038765)

Results Overview

Hamilton Depression Rating Scale. The HAMD is a standardized 17-item interview to measure number and severity of depressive symptoms on a 0-52 score. Higher values indicate a worse outcome. Specifical, HAMD scores can be interpreted as "no depression" (0-7), "mild depression" (8-16), "moderate depression" (17-23) and "severe depression" (24-52).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

220 participants

Primary outcome timeframe

Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis.

Results posted on

2024-01-30

Participant Flow

Patients were referred by their general practitioners or psychiatrists and psychologists in and around Nijmegen, the Netherlands. Alternatively, they were self-referred, informed by local and national advertisements.

Patients were excluded for not having three or more previous depressive episodes (N=19), change in medication within 6 weeks before the start of the study (N=4), previous (hypo)manic episodes (N=2), current substance abuse (N=3), acute need for psychiatric treatment (N=2), unsuitability for groups (N=2), cognitive impairments (N=1).

Participant milestones

Participant milestones
Measure	Mindfulness Based Cognitive Therapy Mindfulness Based Cognitive Therapy Mindfulness Based Cognitive Therapy : 8-weeks group based intervention of mindfulness and cognitive behavioural techniques	Waiting List Control Group (TAU) three month waiting list group receiving treatment as usual
Overall Study STARTED	111	108
Overall Study COMPLETED	102	103
Overall Study NOT COMPLETED	9	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mindfulness Based Cognitive Therapy for Recurrent Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mindfulness Based Cognitive Therapy n=111 Participants Mindfulness Based Cognitive Therapy Mindfulness Based Cognitive Therapy : 8-weeks group based intervention of mindfulness and cognitive behavioural techniques	Waiting List Control Group (TAU) n=108 Participants Three-month waiting list group receiving treatment as usual (TAU)	Total n=219 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	111 Participants n=5 Participants	108 Participants n=7 Participants	219 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	47.3 years STANDARD_DEVIATION 11.5 • n=5 Participants	47.7 years STANDARD_DEVIATION 11.1 • n=7 Participants	47.5 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	74 Participants n=7 Participants	145 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	34 Participants n=7 Participants	74 Participants n=5 Participants
Region of Enrollment Netherlands	111 participants n=5 Participants	108 participants n=7 Participants	219 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis.

Population: Due to missing values, 9 subjects in the MBCT group and 5 from the waiting list control group could not be analysed.

Hamilton Depression Rating Scale. The HAMD is a standardized 17-item interview to measure number and severity of depressive symptoms on a 0-52 score. Higher values indicate a worse outcome. Specifical, HAMD scores can be interpreted as "no depression" (0-7), "mild depression" (8-16), "moderate depression" (17-23) and "severe depression" (24-52).

Outcome measures

Outcome measures
Measure	Mindfulness Based Cognitive Therapy n=102 Participants Mindfulness Based Cognitive Therapy Mindfulness Based Cognitive Therapy : 8-weeks group based intervention of mindfulness and cognitive behavioural techniques	Waiting List Control Group n=103 Participants Waiting list control group, from 0 to 3 months. Patients received usual care but not MBCT.
Depressive Symptoms	7.5 units on a scale Standard Deviation 5.8	10.5 units on a scale Standard Deviation 6.8

SECONDARY outcome

Timeframe: Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis

Beck Depression Inventory (BDI), a 21-item self-report questionnaire to measure depressive symptoms, score range 0-63. Higher scores indicate a worse outcome. Specifically, BDI scores can be interpreted as "minimal depression" (0-13), "mild depression" (14-19), "moderate depression" (20-28) and "severe depression" (29-63).

Outcome measures

Outcome measures
Measure	Mindfulness Based Cognitive Therapy n=102 Participants Mindfulness Based Cognitive Therapy Mindfulness Based Cognitive Therapy : 8-weeks group based intervention of mindfulness and cognitive behavioural techniques	Waiting List Control Group n=103 Participants Waiting list control group, from 0 to 3 months. Patients received usual care but not MBCT.
Self-report Depressive Symptoms	10.3 units on a scale Standard Deviation 7.8	16.2 units on a scale Standard Deviation 9.8

Adverse Events

Mindfulness Based Cognitive Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waiting List Control Group (TAU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anne E.M. Speckens

Radboud University Medical Centre

Phone: 0031243610449

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place