Trial Outcomes & Findings for Dealing With Intrusive Thoughts in OCD - a Comparison of Detached Mindfulness and Cognitive Restructuring (NCT NCT03002753)

Last Updated: 2019-04-16

Results Overview

German version of the Yale-Brown Obsessive Compulsive Scale (Hand \& Büttner-Westphal, 1991). The mininum value is 0, the maximal value is 40. Higher scores indicate a higher symptom severity of obsessive-compulsive disorder.

Recruitment status

COMPLETED

Study phase

Target enrollment

43 participants

Primary outcome timeframe

Difference score resulting from (a) first baseline minus post-treatment (non-waitlist) or (b) first baseline minus second baseline (waitlist). In both cases, there are 2 weeks between the two measurements.

Results posted on

2019-04-16

Participant Flow

Participants were recruited between December 2016 and June 2018.

Participant milestones

Participant milestones
Measure	Detached Mindfulness Group of patients receiving detached mindfulness (for details, see detailed description of the study)	Cognitive Restructuring Group of patients receiving cognitive restructuring (for details, see detailed description of the study)	Waitlist Group of patients who are re-randomized to either Detached Mindfulness or Cognitive Restructuring after a delay of 2 weeks.
First Randomization STARTED	10	12	21
First Randomization COMPLETED	9	11	21
First Randomization NOT COMPLETED	1	1	0
Second Randomization (Re-randomization) STARTED	11	10	0
Second Randomization (Re-randomization) COMPLETED	11	9	0
Second Randomization (Re-randomization) NOT COMPLETED	0	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dealing With Intrusive Thoughts in OCD - a Comparison of Detached Mindfulness and Cognitive Restructuring

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Detached Mindfulness n=21 Participants Group of patients receiving detached mindfulness (for details, see detailed description of the study)	Cognitive Restructuring n=22 Participants Group of patients receiving cognitive restructuring (for details, see detailed description of the study)	Total n=43 Participants Total of all reporting groups
Age, Continuous	30.81 years STANDARD_DEVIATION 9.48 • n=5 Participants	31.23 years STANDARD_DEVIATION 10.96 • n=7 Participants	31.02 years STANDARD_DEVIATION 10.02 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Germany	21 participants n=5 Participants	22 participants n=7 Participants	43 participants n=5 Participants
Number of participants under parallel psychopharmacological medication	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Difference score resulting from (a) first baseline minus post-treatment (non-waitlist) or (b) first baseline minus second baseline (waitlist). In both cases, there are 2 weeks between the two measurements.

Population: People with obsessive-compulsive disorder

Outcome measures

Outcome measures
Measure	Detached Mindfulness n=9 Participants Group of patients receiving detached mindfulness (for details, see detailed description of the study)	Cognitive Restructuring n=11 Participants Group of patients receiving cognitive restructuring (for details, see detailed description of the study)	Waitlist n=20 Participants Waitlist control group, which, however, is again randomized after the waiting time in order to receive one of the two interventions (DM or CR).
Y-BOCS Change Score (Pre to Post Assessment)	5.11 units on a scale Standard Deviation 5.80	5.09 units on a scale Standard Deviation 5.43	0.25 units on a scale Standard Deviation 2.15

Adverse Events

Detached Mindfulness (DM)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cognitive Restructuring (CR)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist (WL)

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

Christian Rupp, M. Sc.

Christoph-Dornier-Stiftung Münster

Phone: 00492514183440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place